Platform Trial of Novel Regimens Versus Standard of Care... | NCT06926673 | Trialant
NCT06926673
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
Jul 3, 2025Actual
Enrollment
62Actual
Phase
Phase 2
Conditions
Neoplasms
Interventions
Dostarlimab
Belrestotug.
Nelistotug
Countries
United States
Canada
France
Germany
Italy
Spain
Protocol Section
Identification Module
NCT ID
NCT06926673
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
205801-003
Secondary IDs
ID
Type
Description
Link
2018-001316-29
EudraCT Number
Brief Title
Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC) - Sub-study 3
Official Title
A Phase II, Randomized, Open-label Platform Trial Utilizing a Master Protocol to Study Novel Regimens Versus Standard of Care Treatment in NSCLC Participants
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Jun 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 23, 2021Actual
Primary Completion Date
May 2, 2024Actual
Completion Date
May 2, 2024Actual
First Submitted Date
Apr 11, 2025
First Submission Date that Met QC Criteria
Apr 11, 2025
First Posted Date
Apr 14, 2025Actual
Results Waived
Not provided
Results First Submitted Date
May 2, 2025
Results First Submitted that Met QC Criteria
Jun 13, 2025
Results First Posted Date
Jul 3, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 13, 2025
Last Update Posted Date
Jul 3, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study is a sub-study of the master protocol 205801 (NCT03739710). This sub study will assess safety and pharmacokinetics and pharmacodynamics (PK/PD) of novel regimens (Dostarlimab plus belrestotug , and Dostarlimab plus belrestotug plus nelistotug) in participants with previously treated NSCLC.
Detailed Description
Not provided
Conditions Module
Conditions
Neoplasms
Keywords
NSCLC
Dostarlimab
Belrestotug
Nelistotug
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
62Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Dostarlimab plus Belrestotug
Experimental
Drug: Dostarlimab
Drug: Belrestotug.
Dostarlimab plus Belrestotug plus Nelistotug
Experimental
Drug: Dostarlimab
Drug: Belrestotug.
Drug: Nelistotug
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Dostarlimab
Drug
Dostarlimab will be administered
Dostarlimab plus Belrestotug
Dostarlimab plus Belrestotug plus Nelistotug
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part 1: Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Arm 4)
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, is life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/ incapacity, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function. SAEs are subset of AEs. A TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
Up to approximately 97 weeks
Part 1: Number of Participants With Any TEAEs and SAEs (Arm 5)
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, is life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/ incapacity, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function. SAEs are subset of AEs. A TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
Up to approximately 107 weeks
Part 1: Number of Participants With Dose Limiting Toxicity (DLT) (Arm 4 and Arm 5)
A DLT is an AE meeting criteria such as, hematologic toxicities of Grade (G) 4 neutropenia/anemia/thrombocytopenia (G3 if bleeding). Non-hematological toxicities include persistent G2 eye events, colitis/diarrhea (G2 unresolved to ≤ G1 within 7 days despite immunosuppressive therapy, G3 for ≥ 72 hours, any G4), G3 pneumonitis, rash (unresolved to ≤ G2 within 2 weeks despite treatment), hypersensitivity/IRR, liver events meeting Hy's Law criteria. G3 toxicity unresolved to ≤G1 or baseline within 3 days with supportive care, or any G4 toxicity. Exclusions include G3 events of electrolyte imbalances correctable within 72 hours without effects, nausea/vomiting/fatigue resolving within 7 days, lymphopenia, and enzyme elevations without pancreatitis. Considerations for DLTs include permanent treatment discontinuation, investigator/sponsor judgment-based events including post-observation period toxicities.
Secondary Outcomes
Measure
Description
Time Frame
Part 1: Objective Response Rate (ORR) (Arm 4)
ORR is defined as the percentage of participants with a best overall confirmed Complete response (CR) or Partial response (PR) at any time as per disease-specific criteria per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete Response (CR) is defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participants capable of giving signed informed consent/assent.
Male or female, aged 18 years or older at the time consent is obtained.
Participants with histologically or cytologically confirmed diagnosis of NSCLC (squamous or non-squamous) and
Documented disease progression based on radiographic imaging, during or after a maximum of 2 lines of systemic treatment for locally/regionally advanced recurrent, Stage IIIb/Stage IIIc/Stage IV or metastatic disease. Two components of treatment must have been received in the same line or as separate lines of therapy: i) No more than or less than 1 line of platinum-containing chemotherapy regimen, and ii) No more than or less than 1 line of Programmed cell death ligand 1 (PD[L]1) monoclonal antibody (mAb) containing regimen.
Participants with known V-Raf Murine Sarcoma Viral Oncogene Homolog B (BRAF) molecular alterations must have had disease progression after receiving the locally available SoC treatment for the molecular alteration.
Participants who received prior anti-PD(L)1 therapy must fulfill the following requirements: i) Have achieved a CR, PR or SD and subsequently had disease progression (per RECIST 1.1 criteria) either on or after completing PD(L)1 therapy ii) Have not progressed or recurred within the first 12 weeks of PD(L)1 therapy, either clinically or per RECIST 1.1 criteria
Measurable disease, presenting with at least 1 measurable lesion per RECIST 1.1.
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.
A tumor tissue sample obtained at any time from the initial diagnosis of NSCLC to time of study entry is mandatory. Although a fresh tumor tissue sample obtained during screening is preferred, archival tumor specimen is acceptable.
Adequate organ function as defined in the protocol.
A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions apply:
i) Not a woman of childbearing potential (WOCBP) as defined in the protocol or ii) A WOCBP who agrees to follow the protocol defined contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.
Life expectancy of at least 12 weeks.
Exclusion Criteria:
Participants who received prior treatment with the following therapies (calculation is based on date of last therapy to date of first dose of study treatment):
Docetaxel at any time.
Any of the investigational agents being tested in the current study.
Systemic approved or investigational anticancer therapy within 30 days or 5 half-lives of the drug, whichever is shorter. At least 14 days must have elapsed between the last dose of prior anticancer agent and the first dose of study drug administered.
Prior radiation therapy: permissible if at least one non-irradiated measurable lesion is available for assessment per RECIST version 1.1 or if a solitary measurable lesion was irradiated, objective progression is documented. A wash out of at least 2 weeks before start of study drug for radiation of any intended use is required.
Received greater than (>) 2 prior lines of therapy for NSCLC, including participants with BRAF molecular alternations.
Invasive malignancy or history of invasive malignancy other than disease under study within the last 2 years.
Carcinomatous meningitis (regardless of clinical status) and uncontrolled or symptomatic Central nervous system (CNS) metastases.
Major surgery less than or equal to (<=) 28 days of first dose of study treatment.
Autoimmune disease (current or history) or syndrome that required systemic treatment within the past 2 years. Replacement therapies which include physiological doses of corticosteroids for treatment of endocrinopathies (for example, adrenal insufficiency) are not considered systemic treatments.
Receiving systemic steroids (>10 milligrams [mg]) oral prednisone or equivalent) or other immunosuppressive agents within 7 days prior to first dose of study treatment. Steroids as premedication for hypersensitivity reactions (e.g., computed tomography [CT] scan premedication) are permitted.
Prior allogeneic/autologous bone marrow or solid organ transplantation.
Receipt of any live vaccine within 30 days prior to first dose of study treatment.
Toxicity from previous anticancer treatment that includes:
1. Greater than or equal to (>=) Grade 3 toxicity considered related to prior immunotherapy and that led to treatment discontinuation.
2. History of myocarditis of any grade during a previous treatment with immunotherapy 3. Toxicity related to prior treatment that has not resolved to <= Grade 1 (except alopecia, hearing loss, endocrinopathy managed with replacement therapy, and peripheral neuropathy which must be <= Grade 2).
History (current and past) of idiopathic pulmonary fibrosis, pneumonitis (for pastpneumonitis exclusion only if steroids were required for treatment), interstitial lung disease, or organizing pneumonia.
Recent history (within the past 6 months) of uncontrolled symptomatic ascites, pleural or pericardial effusions.
Recent history (within the past 6 months) of gastrointestinal obstruction that required surgery, acute diverticulitis, inflammatory bowel disease, or intra-abdominal abscess.
History or evidence of cardiac abnormalities within the 6 months prior to enrollment which include
Serious, uncontrolled cardiac arrhythmia or clinically significant electrocardiogram abnormalities including second degree (Type II) or third degree atrioventricular block.
Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypo-albuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.
Active infection requiring systemic therapy <=7 days prior to first dose of study treatment.
Participants with known human immunodeficiency virus infection.
Participants with history of severe hypersensitivity to mAbs or hypersensitivity to any of the study treatment(s) or their excipients.
Any serious and/or unstable pre-existing medical (aside from malignancy), psychiatric disorder, or other condition that could interfere with participant's safety, obtaining informed consent, or compliance to the study procedures in the opinion of the investigator.
Pregnant or lactating female participants.
Participant who is currently participating in or has participated in a study of an investigational device within 4 weeks prior to the first dose of study treatment.
Participants with presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to first dose of study intervention.
Participants with positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention.
Participants with positive hepatitis C ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study treatment.
Receipt of transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including granulocyte colony stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor, and recombinant erythropoietin) within 14 days before the first dose of study intervention.
Known hypersensitivity to components or excipients of dostarlimab, belrestotug, and/or nelistotug
Has received prior antibodies or drugs targeting TIGIT, CD96, PVRIG, or other therapies targeting the CD226 axis pathway
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
Access Criteria
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.
This is a sub-study of the master study NCT03739710.The master protocol included two parts -Part 1 (non-randomized, safety and PK/PD evaluation) and Part 2 (randomized part comparing safety and efficacy to SoC). Criteria on whether to advance a study regimen from Part 1 to Part 2 has been built into the study design. Having completed Part 1 with the allowable number of patients per protocol, the decision was taken to not enroll participants in Part 2. Part 1 was therefore considered completed.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Enrolled Set Population included all participants who passed screening and were assigned treatment.
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Apr 26, 2023
May 2, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Belrestotug.
Drug
Belrestotug will be administered
Dostarlimab plus Belrestotug
Dostarlimab plus Belrestotug plus Nelistotug
Nelistotug
Drug
Nelistotug will be administered.
Dostarlimab plus Belrestotug plus Nelistotug
Up to 21 days
Part 1: Number of Participants Requiring Dose Modifications (Arm 4)
Number of participants with dose modifications (missed doses, dose delays and infusion interruptions) is summarized.
Up to approximately 97 weeks
Part 1: Number of Participants Requiring Dose Modifications (Arm 5)
Number of participants with dose modifications (missed doses, dose delays and infusion interruptions) is summarized.
Up to approximately 107 weeks
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4)
Performance Status was assessed using the ECOG scale (Grades 0-5), where 0: Fully active, able to carry on all pre-disease performance without restriction. Grade 1: Restricted in physically strenuous activity but ambulatory & able to carry out work of light or sedentary nature; Grade 2 - Ambulatory & capable of all self-care but unable to carry out any work activities. Up and about more than (>) 50% of waking hours; Grade 3 -Capable of only limited self-care, confined to bed or chair > 50% of waking hours; Grade 4 -Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; Grade 5 -Dead.
Up to approximately 97 weeks
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Performance Status was assessed using the ECOG scale (Grades 0-5), where 0: Fully active, able to carry on all pre-disease performance without restriction. Grade 1: Restricted in physically strenuous activity but ambulatory & able to carry out work of light or sedentary nature; Grade 2 - Ambulatory & capable of all self-care but unable to carry out any work activities. Up and about more than (>) 50% of waking hours; Grade 3 -Capable of only limited self-care, confined to bed or chair > 50% of waking hours; Grade 4 -Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; Grade 5 -Dead
Up to approximately 107 weeks
Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4)
Vital signs including systolic blood pressure (SBP), diastolic BP (DBP), pulse rate (PR) and body temperature (BT) were measured for the participants. DBP: Grade 0 (<80 millimeters of mercury [mmHg]), Grade 1 (80-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (>=100 mmHg); SBP: Grade 0 (<120 mmHg), Grade 1 (120-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (>=160 mmHg); PR categories include: 'Decrease to < 60 beats per minutes [bpm]', 'Change to Normal' or 'No Change', and 'Increase to >100 bpm'; BT categories include 'Decrease to <=35 degrees Celsius °C', 'Change to Normal' or 'No Change', and 'Increase to >=38 °C'. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Up to approximately 97 weeks
Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5)
Vital signs including systolic blood pressure (SBP), diastolic BP (DBP), pulse rate (PR) and body temperature (BT) were measured for the participants. DBP: Grade 0 (<80 millimeters of mercury [mmHg]), Grade 1 (80-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (>=100 mmHg); SBP: Grade 0 (<120 mmHg), Grade 1 (120-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (>=160 mmHg); PR categories include: 'Decrease to < 60 beats per minutes [bpm]', 'Change to Normal' or 'No Change', and 'Increase to >100 bpm'; BT categories include 'Decrease to <=35 degrees Celsius °C', 'Change to Normal' or 'No Change', and 'Increase to >=38 °C'. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Up to approximately 107 weeks
Part 1: Number of Participants Who Received Concomitant Medications (Arm 4)
Number of participants who received Concomitant medications is summarized.
Up to approximately 97 weeks
Part 1: Number of Participants Who Received Concomitant Medications (Arm 5)
Number of participants who received Concomitant medications is summarized.
Up to approximately 107 weeks
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline Electrocardiogram (ECG) Findings (Arm 4)
Number of participants with worst-case post baseline (WCPB) from baseline ECG findings is summarized as clinically significant. Data is summarized as Normal, Abnormal - Not Clinically Significant (NCS) and Abnormal - Clinically Significant (CS). Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Up to approximately 97 weeks
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline ECG Findings (Arm 5)
Number of participants with worst-case post baseline (WCPB) from baseline ECG findings is summarized as clinically significant. Data is summarized as Normal, Abnormal - Not Clinically Significant (NCS) and Abnormal - Clinically Significant (CS). Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Up to approximately 107 weeks
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 4)
The QTcF values based on Fridericia formula were rounded to the integer and the values are categorized into the following ranges, inclusively: Grade 0 (<450 millisecond (msec)), Grade 1 (≥450-≤480 msec), Grade 2 (≥481-≤500 msec), and Grade 3 (≥501 msec). Missing baseline grades were assumed to be Grade 0. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Up to approximately 97 weeks
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 5)
The QTcF values based on Fridericia formula were rounded to the integer and the values are categorized into the following ranges, inclusively: Grade 0 (<450 millisecond (msec)), Grade 1 (≥450-≤480 msec), Grade 2 (≥481-≤500 msec), and Grade 3 (≥501 msec). Missing baseline grades were assumed to be Grade 0. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Up to approximately 107 weeks
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 4)
Number of participants with worst case post-baseline in LVEF from baseline is summarized as 'any decrease (>0%-<10% Decrease, 10%-19% Decrease, >=20% Decrease)', '>=10% Decrease and >= Lower limit of normal (LLN)', '>=10% Decrease and < LLN', '>=20% Decrease and >= LLN' and '>=20% Decrease and < LLN' . An increase is defined as an increase in grade relative to Baseline grade. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Up to approximately 97 weeks
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 5)
Number of participants with worst case post-baseline in LVEF from baseline is summarized as 'any decrease (>0%-<10% Decrease, 10%-19% Decrease, >=20% Decrease)', '>=10% Decrease and >= Lower limit of normal (LLN)', '>=10% Decrease and < LLN', '>=20% Decrease and >= LLN' and '>=20% Decrease and < LLN' . An increase is defined as an increase in grade relative to Baseline grade. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Up to approximately 107 weeks
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Blood samples were collected for the analysis of hematology parameters and are categorized in alignment with Common Terminology Criteria for Adverse Events (CTCAE) version 5 as Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; and Grade 4: life-threatening consequences. Higher grade indicates greater severity. An increase in grade is defined relative to the Baseline grade. Participants with missing baseline values are assumed to have baseline value of grade 0. Any worst-case post baseline increase in grade along with any increase to a maximum grade of 3 and 4 is summarized. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Up to approximately 97 weeks
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Blood samples were collected for the analysis of hematology parameters and are categorized in alignment with Common Terminology Criteria for Adverse Events (CTCAE) version 5 as Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; and Grade 4: life-threatening consequences. Higher grade indicates greater severity. An increase in grade is defined relative to the Baseline grade. Participants with missing baseline values are assumed to have baseline value of grade 0. Any worst-case post baseline increase in grade along with any increase to a maximum grade of 3 and 4 is summarized. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Up to approximately 107 weeks
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Blood samples were collected for the analysis of clinical chemistry parameters and are categorized in alignment with Common Terminology Criteria for Adverse Events (CTCAE) version 5 as Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; and Grade 4: life-threatening consequences. Higher grade indicates greater severity. An increase in grade is defined relative to the Baseline grade. Participants with missing baseline values are assumed to have baseline value of grade 0. Any worst-case post baseline increase in grade along with any increase to a maximum grade of 3 and 4 is summarized. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Up to approximately 97 weeks
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Blood samples were collected for the analysis of clinical chemistry parameters and are categorized in alignment with Common Terminology Criteria for Adverse Events (CTCAE) version 5 as Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; and Grade 4: life-threatening consequences. Higher grade indicates greater severity. An increase in grade is defined relative to the Baseline grade. Participants with missing baseline values are assumed to have baseline value of grade 0. Any worst-case post baseline increase in grade along with any increase to a maximum grade of 3 and 4 is summarized. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Up to approximately 107 weeks
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Blood samples were collected for analysis of clinical chemistry. The summaries of worst-case post baseline (WCPB) from baseline (B) with respect to normal range was analyzed. Data is presented as "XXX B YYY, WCPB YYY", where XXX denotes lab parameter and YYY is high/normal/low. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Up to approximately 97 weeks
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Blood samples were collected for analysis of clinical chemistry. The summaries of worst-case post baseline (WCPB) from baseline (B) with respect to normal range was analyzed. Data is presented as "XXX B YYY, WCPB YYY", where XXX denotes lab parameter and YYY is high/normal/low. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Up to approximately 107 weeks
Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 4)
Urinalysis was performed. Participants with missing value at baseline are assumed to be negative at baseline. All increases are from baseline. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Up to approximately 97 weeks
Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 5)
Urinalysis was performed. Participants with missing value at baseline are assumed to be negative at baseline. All increases are from baseline. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Up to approximately 107 weeks
Part 2: Overall Survival (OS)
OS is defined as the time from date of randomization to the date of death, irrespective of the cause of death.
Up to approximately 107 weeks
Up to approximately 97 weeks
Part 1: Objective Response Rate (ORR) (Arm 5)
ORR is defined as the percentage of participants with a best overall confirmed CR or PR at any time as per disease-specific criteria per RECIST version 1.1. CR is defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline).
Up to approximately 107 weeks
Part 1: Disease Control Rate (DCR) (Arm 4)
DCR is defined as the percentage of participants with a confirmed CR + PR at any time, plus SD =>12 weeks as per RECIST v1.1. Complete Response (CR) is defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
Up to approximately 97 weeks
Part 1: Disease Control Rate (DCR) (Arm 5)
DCR is defined as the percentage of participants with a confirmed CR + PR at any time, plus SD =>12 weeks as per RECIST v1.1. Complete Response (CR) is defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
Up to approximately 107 weeks
Part 1: Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Belrestotug (Arm 4)
Blood samples were collected for pharmacokinetic analysis of Belrestotug.
Up to 21 days (Cycle 1)
Part 1: Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Belrestotug (Arm 5)
Blood samples were collected for pharmacokinetic analysis of Belrestotug.
Up to 21 days (Cycle 1)
Part 1: Cmax and Cmin of Dostarlimab (Arm 4)
Blood samples were collected for pharmacokinetic analysis of Dostarlimab.
Up to 21 days (Cycle 1)
Part 1: Cmax and Cmin of Dostarlimab (Arm 5)
Blood samples were collected for pharmacokinetic analysis of Dostarlimab.
Up to 21 days (Cycle 1)
Part 1: Cmax and Cmin of Nelistotug (Arm 5)
Blood samples were collected for pharmacokinetic analysis of Nelistotug.
Up to 21 days (Cycle 1)
Part 2: Survival Rate at 12 and 18 Months
Survival rate was planned to be anaysed at 12 and 18 months
At 12 and 18 months
Part 2: Number of Participants With Complete Response (CR), Partial Response (PR), Stable Disease (SD) and Progressive Disease (PD)
CR, PR, SD and PD was planned to be evaluated as per RECIST version 1.1 criteria. Complete Response (CR) is defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5mm.
Up to approximately 107 weeks
Part 2: Progression-free Survival (PFS)
PFS is defined as time from the date of randomization to the date of disease progression as per RECIST v1.1. or death whichever occurs earlier. Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5mm.
Up to approximately 107 weeks
Part 2: Objective Response Rate (ORR)
ORR is defined as the percentage of participants with a best overall confirmed Complete response (CR) or Partial response (PR) at any time as per disease-specific criteria per RECIST version 1.1. Complete Response (CR) is defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline).
Up to approximately 107 weeks
Part 2: Duration of Response (DOR)
DOR is defined as the time for first documented evidence of CR or PR until disease progression or death, per RECIST 1.1 criteria. Complete Response (CR) is defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
Up to approximately 107 weeks
Part 2: Disease Control Rate (DCR)
DCR is defined as the percentage of participants with a confirmed CR + PR at any time, plus SD =>12 weeks as per RECIST v1.1. Complete Response (CR) is defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
Up to approximately 107 weeks
Part 2: Number of Participants With Immune-based (i) Complete Response (iCR), Partial Response (iPR), Unconfirmed Progressive Disease (iUPD), Confirmed Progressive Disease (iCPD), and Stable Disease (iSD)
Modified RECIST 1.1 for immune-based therapeutics (iRECIST) is based on RECIST v 1.1 but adapted to account for the unique tumor response seen with immunotherapeutic drugs. iRECIST is used to assess tumor response and progression and make treatment decisions. iCR: disappearance of all target lesions; iPR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). iCPD: either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; iSD: stable disease in the absence of CR or PD and iUPD: unconfirmed progressive disease when PD is unconfirmed and NE: not evaluable.
Up to approximately 107 weeks
Part 2: Progression-free Survival (iPFS)
iPFS is defined as time from the date of randomization to the date of disease progression or death, whichever occurs earlier, per iRECIST criteria. Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5mm.
Up to approximately 107 weeks
Part 2: Objective Response Rate (iORR)
iORR is defined as the percentage of participants with a confirmed iCR or iPR at any time per iRECIST criteria. iCR is defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. iPR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
Up to approximately 107 weeks
Part 2: Duration of Response (iDOR)
iDOR is defined as the time from first documented evidence of CR or PR until disease progression or death, per iRECIST criteria. iCR is defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. iPR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
Up to approximately 107 weeks
Part 2: Number of Participants With AEs, SAEs, Adverse Events of Special Interest (AESI), AE/SAEs Leading to Dose Modifications/Delays/Withdrawals
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, any other situation such as important medical events according to medical or scientific judgement. AESI are considered to be Infusion Related Reactions (IRRs) and those of potential immunologic etiology. AEs were planned to be coded using the MedDRA coding system.
Up to approximately 107 weeks
Part 2: Number of Participants With Clinically Significant Changes in Vital Signs and Laboratory Parameters
Clinically significant changes in vital signs were planned to be assessed. Blood samples were planned to be collected for the analysis of laboratory parameters.
Up to approximately 107 weeks
Part 2: Cmax and Cmin for Dostarlimab
Blood samples were planned to be collected to assess the pharmacokinetics of Dostarlimab.
Up to approximately 107 weeks
Part 2: Cmax and Cmin for Belrestotug
Blood samples were planned to be collected to assess the pharmacokinetics of Belrestotug.
Up to approximately 107 weeks
Part 2: Number of Participants With Positive Anti-drug Antibodies (ADA)
Serum samples were planned to be collected for the analysis of the presence of ADAs using validated immunoassays.
Up to approximately 107 weeks
Edmonton
Alberta
T6G 1Z2
Canada
GSK Investigational Site
Brampton
Ontario
L6R 3J7
Canada
GSK Investigational Site
Toronto
Ontario
M5G 2M9
Canada
GSK Investigational Site
Bordeaux
33076
France
GSK Investigational Site
Paris
75018
France
GSK Investigational Site
Paris
75248
France
GSK Investigational Site
Villejuif
94805
France
GSK Investigational Site
Großhansdorf
22927
Germany
GSK Investigational Site
Meldola FC
47014
Italy
GSK Investigational Site
Milan
20133
Italy
GSK Investigational Site
Siena
53100
Italy
GSK Investigational Site
Barcelona
08035
Spain
GSK Investigational Site
Madrid
28034
Spain
GSK Investigational Site
Málaga
29010
Spain
FG001
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
FG002
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug MD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
FG004
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
FG006
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
FG0006 subjects
FG0019 subjects
FG0029 subjects
FG00310 subjects
FG0047 subjects
FG00511 subjects
FG00610 subjects
DLT Evaluable Population
All participants who took at least one dose of study treatment and followed for the DLT observation period or were withdrew within the DLT observation period due to meeting the DLT criteria and no resolution/recovery.
FG0000 subjects
FG0014 subjects
FG0024 subjects
FG0034 subjects
FG0047 subjects
FG0050 subjects
FG0060 subjects
COMPLETED
Participants who completed follow-up or who died were considered to have completed the study.
FG0006 subjects2 participants completed follow-up and 4 died
FG0016 subjects1 participant completed follow-up and 5 died
FG0027 subjects7 participants died
FG0038 subjects1 participant completed follow-up and 7 died
FG0047 subjects3 participants completed follow-up and 4 died
FG0059 subjects2 participant completed follow-up and 7 died
FG0069 subjects3 participants completed follow-up and 6 died
NOT COMPLETED
FG0000 subjects
FG0013 subjects
FG0022 subjects
FG0032 subjects
FG0040 subjects
FG0052 subjects
FG0061 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0013 subjects
FG0022 subjects
FG0031 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
BG001
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
BG002
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug MD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
BG004
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
BG006
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0006
BG0019
BG0029
BG00310
BG0047
BG00511
BG00610
BG00762
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
18 to >=85 years
BG0006
BG0019
BG0029
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0013
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Part 1: Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Arm 4)
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, is life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/ incapacity, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function. SAEs are subset of AEs. A TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
Posted
Count of Participants
Participants
Up to approximately 97 weeks
ID
Title
Description
OG000
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG001
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG002
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Units
Counts
Participants
OG0006
OG0019
OG0029
Title
Denominators
Categories
Any TEAEs
Title
Measurements
OG0006
OG0019
OG0028
Any SAEs
Primary
Part 1: Number of Participants With Any TEAEs and SAEs (Arm 5)
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, is life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/ incapacity, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function. SAEs are subset of AEs. A TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug MD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
OG001
Primary
Part 1: Number of Participants With Dose Limiting Toxicity (DLT) (Arm 4 and Arm 5)
A DLT is an AE meeting criteria such as, hematologic toxicities of Grade (G) 4 neutropenia/anemia/thrombocytopenia (G3 if bleeding). Non-hematological toxicities include persistent G2 eye events, colitis/diarrhea (G2 unresolved to ≤ G1 within 7 days despite immunosuppressive therapy, G3 for ≥ 72 hours, any G4), G3 pneumonitis, rash (unresolved to ≤ G2 within 2 weeks despite treatment), hypersensitivity/IRR, liver events meeting Hy's Law criteria. G3 toxicity unresolved to ≤G1 or baseline within 3 days with supportive care, or any G4 toxicity. Exclusions include G3 events of electrolyte imbalances correctable within 72 hours without effects, nausea/vomiting/fatigue resolving within 7 days, lymphopenia, and enzyme elevations without pancreatitis. Considerations for DLTs include permanent treatment discontinuation, investigator/sponsor judgment-based events including post-observation period toxicities.
DLT-evaluable participants included all participants who took at least 1 dose of study intervention and were followed for the DLT observation period or were withdrawn within the DLT observation period due to meeting the DLT criteria and no resolution/recovery per dose modifications and toxicity management guidelines.
Posted
Count of Participants
Participants
Up to 21 days
ID
Title
Description
OG000
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Primary
Part 1: Number of Participants Requiring Dose Modifications (Arm 4)
Number of participants with dose modifications (missed doses, dose delays and infusion interruptions) is summarized.
Safety Population.
Posted
Count of Participants
Participants
Up to approximately 97 weeks
ID
Title
Description
OG000
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG001
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG002
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
Primary
Part 1: Number of Participants Requiring Dose Modifications (Arm 5)
Number of participants with dose modifications (missed doses, dose delays and infusion interruptions) is summarized.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug MD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
OG001
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
OG002
Primary
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4)
Performance Status was assessed using the ECOG scale (Grades 0-5), where 0: Fully active, able to carry on all pre-disease performance without restriction. Grade 1: Restricted in physically strenuous activity but ambulatory & able to carry out work of light or sedentary nature; Grade 2 - Ambulatory & capable of all self-care but unable to carry out any work activities. Up and about more than (>) 50% of waking hours; Grade 3 -Capable of only limited self-care, confined to bed or chair > 50% of waking hours; Grade 4 -Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; Grade 5 -Dead.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Count of Participants
Participants
Up to approximately 97 weeks
ID
Title
Description
OG000
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG001
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
Primary
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Performance Status was assessed using the ECOG scale (Grades 0-5), where 0: Fully active, able to carry on all pre-disease performance without restriction. Grade 1: Restricted in physically strenuous activity but ambulatory & able to carry out work of light or sedentary nature; Grade 2 - Ambulatory & capable of all self-care but unable to carry out any work activities. Up and about more than (>) 50% of waking hours; Grade 3 -Capable of only limited self-care, confined to bed or chair > 50% of waking hours; Grade 4 -Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; Grade 5 -Dead
Safety Population. Only those participants with data available at specified time points have been analyzed.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug MD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
OG001
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Primary
Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4)
Vital signs including systolic blood pressure (SBP), diastolic BP (DBP), pulse rate (PR) and body temperature (BT) were measured for the participants. DBP: Grade 0 (<80 millimeters of mercury [mmHg]), Grade 1 (80-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (>=100 mmHg); SBP: Grade 0 (<120 mmHg), Grade 1 (120-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (>=160 mmHg); PR categories include: 'Decrease to < 60 beats per minutes [bpm]', 'Change to Normal' or 'No Change', and 'Increase to >100 bpm'; BT categories include 'Decrease to <=35 degrees Celsius °C', 'Change to Normal' or 'No Change', and 'Increase to >=38 °C'. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Safety Population. Only those participants with data available at specified parameters have been analyzed.
Posted
Count of Participants
Participants
Up to approximately 97 weeks
ID
Title
Description
OG000
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG001
Primary
Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5)
Vital signs including systolic blood pressure (SBP), diastolic BP (DBP), pulse rate (PR) and body temperature (BT) were measured for the participants. DBP: Grade 0 (<80 millimeters of mercury [mmHg]), Grade 1 (80-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (>=100 mmHg); SBP: Grade 0 (<120 mmHg), Grade 1 (120-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (>=160 mmHg); PR categories include: 'Decrease to < 60 beats per minutes [bpm]', 'Change to Normal' or 'No Change', and 'Increase to >100 bpm'; BT categories include 'Decrease to <=35 degrees Celsius °C', 'Change to Normal' or 'No Change', and 'Increase to >=38 °C'. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Safety Population. Only those participants with data available at specified parameters have been analyzed.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug MD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
Primary
Part 1: Number of Participants Who Received Concomitant Medications (Arm 4)
Number of participants who received Concomitant medications is summarized.
Intent To Treat (ITT) population included all participants who were randomized to treatment regardless of whether the participants actually received study treatment.
Posted
Count of Participants
Participants
Up to approximately 97 weeks
ID
Title
Description
OG000
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG001
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG002
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
Primary
Part 1: Number of Participants Who Received Concomitant Medications (Arm 5)
Number of participants who received Concomitant medications is summarized.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug MD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
OG001
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
OG002
Primary
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline Electrocardiogram (ECG) Findings (Arm 4)
Number of participants with worst-case post baseline (WCPB) from baseline ECG findings is summarized as clinically significant. Data is summarized as Normal, Abnormal - Not Clinically Significant (NCS) and Abnormal - Clinically Significant (CS). Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Count of Participants
Participants
Up to approximately 97 weeks
ID
Title
Description
OG000
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG001
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Primary
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline ECG Findings (Arm 5)
Number of participants with worst-case post baseline (WCPB) from baseline ECG findings is summarized as clinically significant. Data is summarized as Normal, Abnormal - Not Clinically Significant (NCS) and Abnormal - Clinically Significant (CS). Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug MD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
OG001
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
Primary
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 4)
The QTcF values based on Fridericia formula were rounded to the integer and the values are categorized into the following ranges, inclusively: Grade 0 (<450 millisecond (msec)), Grade 1 (≥450-≤480 msec), Grade 2 (≥481-≤500 msec), and Grade 3 (≥501 msec). Missing baseline grades were assumed to be Grade 0. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Count of Participants
Participants
Up to approximately 97 weeks
ID
Title
Description
OG000
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG001
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Primary
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 5)
The QTcF values based on Fridericia formula were rounded to the integer and the values are categorized into the following ranges, inclusively: Grade 0 (<450 millisecond (msec)), Grade 1 (≥450-≤480 msec), Grade 2 (≥481-≤500 msec), and Grade 3 (≥501 msec). Missing baseline grades were assumed to be Grade 0. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug MD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
OG001
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
Primary
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 4)
Number of participants with worst case post-baseline in LVEF from baseline is summarized as 'any decrease (>0%-<10% Decrease, 10%-19% Decrease, >=20% Decrease)', '>=10% Decrease and >= Lower limit of normal (LLN)', '>=10% Decrease and < LLN', '>=20% Decrease and >= LLN' and '>=20% Decrease and < LLN' . An increase is defined as an increase in grade relative to Baseline grade. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Posted
Count of Participants
Participants
Up to approximately 97 weeks
ID
Title
Description
OG000
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG001
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
Primary
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 5)
Number of participants with worst case post-baseline in LVEF from baseline is summarized as 'any decrease (>0%-<10% Decrease, 10%-19% Decrease, >=20% Decrease)', '>=10% Decrease and >= Lower limit of normal (LLN)', '>=10% Decrease and < LLN', '>=20% Decrease and >= LLN' and '>=20% Decrease and < LLN' . An increase is defined as an increase in grade relative to Baseline grade. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Safety Population. Only those participants with data available at specified time points have been analyzed.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug MD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
OG001
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Primary
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Blood samples were collected for the analysis of hematology parameters and are categorized in alignment with Common Terminology Criteria for Adverse Events (CTCAE) version 5 as Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; and Grade 4: life-threatening consequences. Higher grade indicates greater severity. An increase in grade is defined relative to the Baseline grade. Participants with missing baseline values are assumed to have baseline value of grade 0. Any worst-case post baseline increase in grade along with any increase to a maximum grade of 3 and 4 is summarized. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Safety Population. Only those participants with data available at specified parameters have been analyzed.
Posted
Count of Participants
Participants
Up to approximately 97 weeks
ID
Title
Description
OG000
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Primary
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Blood samples were collected for the analysis of hematology parameters and are categorized in alignment with Common Terminology Criteria for Adverse Events (CTCAE) version 5 as Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; and Grade 4: life-threatening consequences. Higher grade indicates greater severity. An increase in grade is defined relative to the Baseline grade. Participants with missing baseline values are assumed to have baseline value of grade 0. Any worst-case post baseline increase in grade along with any increase to a maximum grade of 3 and 4 is summarized. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Safety Population. Only those participants with data available at specified parameters have been analyzed.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug MD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
Primary
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Blood samples were collected for the analysis of clinical chemistry parameters and are categorized in alignment with Common Terminology Criteria for Adverse Events (CTCAE) version 5 as Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; and Grade 4: life-threatening consequences. Higher grade indicates greater severity. An increase in grade is defined relative to the Baseline grade. Participants with missing baseline values are assumed to have baseline value of grade 0. Any worst-case post baseline increase in grade along with any increase to a maximum grade of 3 and 4 is summarized. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Safety Population. Only those participants with data available at specified parameters have been analyzed.
Posted
Count of Participants
Participants
Up to approximately 97 weeks
ID
Title
Description
OG000
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Primary
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Blood samples were collected for the analysis of clinical chemistry parameters and are categorized in alignment with Common Terminology Criteria for Adverse Events (CTCAE) version 5 as Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; and Grade 4: life-threatening consequences. Higher grade indicates greater severity. An increase in grade is defined relative to the Baseline grade. Participants with missing baseline values are assumed to have baseline value of grade 0. Any worst-case post baseline increase in grade along with any increase to a maximum grade of 3 and 4 is summarized. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Safety Population. Only those participants with data available at specified parameters have been analyzed.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug MD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
Primary
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Blood samples were collected for analysis of clinical chemistry. The summaries of worst-case post baseline (WCPB) from baseline (B) with respect to normal range was analyzed. Data is presented as "XXX B YYY, WCPB YYY", where XXX denotes lab parameter and YYY is high/normal/low. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Safety Population. Only those participants with data available at specified parameters have been analyzed. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%.When lab values were not analyzed for some participants, the Number of Participants Analyzed will be less than the total across categories, allowing for a direct comparison without adding an "Unknown" or "Data missing" category.
Posted
Count of Participants
Participants
Up to approximately 97 weeks
ID
Title
Description
OG000
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Primary
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Blood samples were collected for analysis of clinical chemistry. The summaries of worst-case post baseline (WCPB) from baseline (B) with respect to normal range was analyzed. Data is presented as "XXX B YYY, WCPB YYY", where XXX denotes lab parameter and YYY is high/normal/low. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Safety Population. Only those participants with data available at specified parameters have been analyzed. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%. When lab values were not analyzed for some participants, the Number of Participants Analyzed will be less than the total across categories, allowing for a direct comparison without adding an "Unknown" or "Data missing" category.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug MD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
Primary
Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 4)
Urinalysis was performed. Participants with missing value at baseline are assumed to be negative at baseline. All increases are from baseline. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Safety Population. Only those participants with data available at specified parameters have been analyzed.
Posted
Count of Participants
Participants
Up to approximately 97 weeks
ID
Title
Description
OG000
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG001
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Primary
Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 5)
Urinalysis was performed. Participants with missing value at baseline are assumed to be negative at baseline. All increases are from baseline. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Safety Population. Only those participants with data available at specified parameters have been analyzed.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug MD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
OG001
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
Primary
Part 2: Overall Survival (OS)
OS is defined as the time from date of randomization to the date of death, irrespective of the cause of death.
No participants were enrolled in Part 2 of the study. Hence, data was not collected.
Posted
Up to approximately 107 weeks
ID
Title
Description
OG000
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG001
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG002
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Secondary
Part 1: Objective Response Rate (ORR) (Arm 4)
ORR is defined as the percentage of participants with a best overall confirmed Complete response (CR) or Partial response (PR) at any time as per disease-specific criteria per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete Response (CR) is defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline).
Intent To Treat (ITT) population.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 97 weeks
ID
Title
Description
OG000
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG001
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Secondary
Part 1: Objective Response Rate (ORR) (Arm 5)
ORR is defined as the percentage of participants with a best overall confirmed CR or PR at any time as per disease-specific criteria per RECIST version 1.1. CR is defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline).
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug MD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
OG001
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
Secondary
Part 1: Disease Control Rate (DCR) (Arm 4)
DCR is defined as the percentage of participants with a confirmed CR + PR at any time, plus SD =>12 weeks as per RECIST v1.1. Complete Response (CR) is defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
Intent To Treat (ITT) population
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 97 weeks
ID
Title
Description
OG000
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG001
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Secondary
Part 1: Disease Control Rate (DCR) (Arm 5)
DCR is defined as the percentage of participants with a confirmed CR + PR at any time, plus SD =>12 weeks as per RECIST v1.1. Complete Response (CR) is defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug MD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
OG001
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
Secondary
Part 1: Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Belrestotug (Arm 4)
Blood samples were collected for pharmacokinetic analysis of Belrestotug.
Pharmacokinetic (PK) population included all participants from the ITT Population from whom a blood sample is obtained and analyzed for PK concentration. PK parameters were only calculated for treatment cycles in which sufficient data were available to do so.
Posted
Mean
Standard Deviation
Microgram/ millilitre (ug/mL)
Up to 21 days (Cycle 1)
ID
Title
Description
OG000
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG001
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Secondary
Part 1: Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Belrestotug (Arm 5)
Blood samples were collected for pharmacokinetic analysis of Belrestotug.
Pharmacokinetic (PK) population. PK parameters were only calculated for treatment cycles in which sufficient data were available to do so.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug MD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
OG001
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
Secondary
Part 1: Cmax and Cmin of Dostarlimab (Arm 4)
Blood samples were collected for pharmacokinetic analysis of Dostarlimab.
Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed. PK parameters were only calculated for treatment cycles in which sufficient data were available to do so.
Posted
Mean
Standard Deviation
ug/mL
Up to 21 days (Cycle 1)
ID
Title
Description
OG000
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG001
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG002
Secondary
Part 1: Cmax and Cmin of Dostarlimab (Arm 5)
Blood samples were collected for pharmacokinetic analysis of Dostarlimab.
Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed. PK parameters were only calculated for treatment cycles in which sufficient data were available to do so.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug MD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
OG001
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
Secondary
Part 1: Cmax and Cmin of Nelistotug (Arm 5)
Blood samples were collected for pharmacokinetic analysis of Nelistotug.
Pharmacokinetic (PK) population. PK parameters were only calculated for treatment cycles in which sufficient data were available to do so.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug MD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
OG001
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
Secondary
Part 2: Survival Rate at 12 and 18 Months
Survival rate was planned to be anaysed at 12 and 18 months
No participants were enrolled in Part 2 of the study. Hence, data was not collected.
Posted
At 12 and 18 months
ID
Title
Description
OG000
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG001
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG002
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Secondary
Part 2: Number of Participants With Complete Response (CR), Partial Response (PR), Stable Disease (SD) and Progressive Disease (PD)
CR, PR, SD and PD was planned to be evaluated as per RECIST version 1.1 criteria. Complete Response (CR) is defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5mm.
No participants were enrolled in Part 2 of the study. Hence, data was not collected.
Posted
Up to approximately 107 weeks
ID
Title
Description
OG000
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Secondary
Part 2: Progression-free Survival (PFS)
PFS is defined as time from the date of randomization to the date of disease progression as per RECIST v1.1. or death whichever occurs earlier. Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5mm.
No participants were enrolled in Part 2 of the study. Hence, data was not collected.
Posted
Up to approximately 107 weeks
ID
Title
Description
OG000
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG001
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Secondary
Part 2: Objective Response Rate (ORR)
ORR is defined as the percentage of participants with a best overall confirmed Complete response (CR) or Partial response (PR) at any time as per disease-specific criteria per RECIST version 1.1. Complete Response (CR) is defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline).
No participants were enrolled in Part 2 of the study. Hence, data was not collected.
Posted
Up to approximately 107 weeks
ID
Title
Description
OG000
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG001
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Secondary
Part 2: Duration of Response (DOR)
DOR is defined as the time for first documented evidence of CR or PR until disease progression or death, per RECIST 1.1 criteria. Complete Response (CR) is defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
No participants were enrolled in Part 2 of the study. Hence, data was not collected.
Posted
Up to approximately 107 weeks
ID
Title
Description
OG000
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG001
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Secondary
Part 2: Disease Control Rate (DCR)
DCR is defined as the percentage of participants with a confirmed CR + PR at any time, plus SD =>12 weeks as per RECIST v1.1. Complete Response (CR) is defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
No participants were enrolled in Part 2 of the study. Hence, data was not collected.
Posted
Up to approximately 107 weeks
ID
Title
Description
OG000
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG001
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Secondary
Part 2: Number of Participants With Immune-based (i) Complete Response (iCR), Partial Response (iPR), Unconfirmed Progressive Disease (iUPD), Confirmed Progressive Disease (iCPD), and Stable Disease (iSD)
Modified RECIST 1.1 for immune-based therapeutics (iRECIST) is based on RECIST v 1.1 but adapted to account for the unique tumor response seen with immunotherapeutic drugs. iRECIST is used to assess tumor response and progression and make treatment decisions. iCR: disappearance of all target lesions; iPR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). iCPD: either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; iSD: stable disease in the absence of CR or PD and iUPD: unconfirmed progressive disease when PD is unconfirmed and NE: not evaluable.
No participants were enrolled in Part 2 of the study. Hence, data was not collected.
Posted
Up to approximately 107 weeks
ID
Title
Description
OG000
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG001
Secondary
Part 2: Progression-free Survival (iPFS)
iPFS is defined as time from the date of randomization to the date of disease progression or death, whichever occurs earlier, per iRECIST criteria. Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5mm.
No participants were enrolled in Part 2 of the study. Hence, data was not collected.
Posted
Up to approximately 107 weeks
ID
Title
Description
OG000
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG001
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Secondary
Part 2: Objective Response Rate (iORR)
iORR is defined as the percentage of participants with a confirmed iCR or iPR at any time per iRECIST criteria. iCR is defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. iPR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
No participants were enrolled in Part 2 of the study. Hence, data was not collected.
Posted
Up to approximately 107 weeks
ID
Title
Description
OG000
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG001
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Secondary
Part 2: Duration of Response (iDOR)
iDOR is defined as the time from first documented evidence of CR or PR until disease progression or death, per iRECIST criteria. iCR is defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. iPR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
No participants were enrolled in Part 2 of the study. Hence, data was not collected.
Posted
Up to approximately 107 weeks
ID
Title
Description
OG000
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG001
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Secondary
Part 2: Number of Participants With AEs, SAEs, Adverse Events of Special Interest (AESI), AE/SAEs Leading to Dose Modifications/Delays/Withdrawals
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, any other situation such as important medical events according to medical or scientific judgement. AESI are considered to be Infusion Related Reactions (IRRs) and those of potential immunologic etiology. AEs were planned to be coded using the MedDRA coding system.
No participants were enrolled in Part 2 of the study. Hence, data was not collected.
Posted
Up to approximately 107 weeks
ID
Title
Description
OG000
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG001
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
Secondary
Part 2: Number of Participants With Clinically Significant Changes in Vital Signs and Laboratory Parameters
Clinically significant changes in vital signs were planned to be assessed. Blood samples were planned to be collected for the analysis of laboratory parameters.
No participants were enrolled in Part 2 of the study. Hence, data was not collected.
Posted
Up to approximately 107 weeks
ID
Title
Description
OG000
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG001
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG002
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
Secondary
Part 2: Cmax and Cmin for Dostarlimab
Blood samples were planned to be collected to assess the pharmacokinetics of Dostarlimab.
No participants were enrolled in Part 2 of the study. Hence, data was not collected.
Posted
Up to approximately 107 weeks
ID
Title
Description
OG000
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG001
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG002
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Secondary
Part 2: Cmax and Cmin for Belrestotug
Blood samples were planned to be collected to assess the pharmacokinetics of Belrestotug.
No participants were enrolled in Part 2 of the study. Hence, data was not collected.
Posted
Up to approximately 107 weeks
ID
Title
Description
OG000
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG001
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG002
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Secondary
Part 2: Number of Participants With Positive Anti-drug Antibodies (ADA)
Serum samples were planned to be collected for the analysis of the presence of ADAs using validated immunoassays.
No participants were enrolled in Part 2 of the study. Hence, data was not collected.
Posted
Up to approximately 107 weeks
ID
Title
Description
OG000
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG001
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG002
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
Time Frame
All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Description
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
4
6
0
6
6
6
EG001
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
5
9
3
9
9
9
EG002
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)])
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug MD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
7
10
3
10
10
10
EG004
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
7
11
3
11
11
11
EG006
Arm 5 Randomized Part: Belrestotug(MD) + Dostarlimab + Nelistotug (HD)
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received various dose levels.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Cranial nerve disorder
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Dizziness
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Dysaesthesia
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected9 at risk
EG003
Headache
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected9 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Migraine
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Sensory loss
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Somnolence
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Abnormal dreams
Psychiatric disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected9 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events2 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Depression
Psychiatric disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Azotaemia
Renal and urinary disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Nephritis
Renal and urinary disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected9 at risk
EG003
Gynaecomastia
Reproductive system and breast disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected9 at risk
EG003
Bronchial fistula
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Bronchial obstruction
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events2 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Immune-mediated lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected9 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected9 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Capillaritis
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected9 at risk
EG003
Dermatitis psoriasiform
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected9 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0021 events1 affected9 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0004 events2 affected6 at risk
EG0013 events3 affected9 at risk
EG0022 events2 affected9 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0002 events2 affected6 at risk
EG0011 events1 affected9 at risk
EG0021 events1 affected9 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0003 events1 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected9 at risk
EG003
Rash vesicular
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Skin disorder
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected9 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected9 at risk
EG003
Skin plaque
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Hypertension
Vascular disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Hypotension
Vascular disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
OG003
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
Units
Counts
Participants
OG00010
OG0017
OG00211
OG00310
Title
Denominators
Categories
Any TEAEs
Title
Measurements
OG00010
OG0016
OG00211
OG0039
Any SAEs
Title
Measurements
OG0003
OG0013
OG0023
OG003
OG001
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug MD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
OG003
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
Units
Counts
Participants
OG0004
OG0014
OG0024
OG0037
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0031
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
OG003
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
Units
Counts
Participants
OG00010
OG0017
OG00211
OG00310
Title
Denominators
Categories
Missed Doses
Title
Measurements
OG0006
OG0012
OG0025
OG0036
Dose Delays
Title
Measurements
OG0001
OG0010
OG0020
OG003
Infusion Interruptions
Title
Measurements
OG0000
OG0012
OG0020
OG003
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG002
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Units
Counts
Participants
OG0006
OG0019
OG0029
Title
Denominators
Categories
Baseline, Grade 0
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0029
Title
Measurements
OG0000
OG0015
OG0023
Baseline, Grade 1
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0029
Title
Measurements
OG000
Week 4, Grade 0
ParticipantsOG0006
ParticipantsOG0018
ParticipantsOG0028
Title
Measurements
OG000
Week 4, Grade 1
ParticipantsOG0006
ParticipantsOG0018
ParticipantsOG0028
Title
Measurements
OG000
Week 4, Grade 2
ParticipantsOG0006
ParticipantsOG0018
ParticipantsOG0028
Title
Measurements
OG000
Week 7, Grade 0
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0026
Title
Measurements
OG000
Week 7, Grade 1
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0026
Title
Measurements
OG000
Week 10, Grade 0
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0024
Title
Measurements
OG000
Week 10, Grade 1
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0024
Title
Measurements
OG000
Week 13, Grade 0
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0022
Title
Measurements
OG000
Week 13, Grade 1
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0022
Title
Measurements
OG000
Week 16, Grade 0
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0021
Title
Measurements
OG000
Week 16, Grade 1
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0021
Title
Measurements
OG000
Week 19, Grade 0
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0021
Title
Measurements
OG000
Week 19, Grade 1
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0021
Title
Measurements
OG000
Week 22, Grade 0
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0021
Title
Measurements
OG000
Week 22, Grade 1
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0021
Title
Measurements
OG000
Week 25, Grade 0
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0021
Title
Measurements
OG001
Week 25, Grade 1
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0021
Title
Measurements
OG001
Week 28, Grade 0
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0021
Title
Measurements
OG001
Week 28 Grade 1
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0021
Title
Measurements
OG001
Week 31, Grade 0
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0021
Title
Measurements
OG001
Week 34, Grade 0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
Title
Measurements
OG002
Week 37, Grade 0
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0021
Title
Measurements
OG001
Week 40, Grade 0
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
Title
Measurements
OG001
Week 43, Grade 0
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
Title
Measurements
OG001
Week 46, Grade 0
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
Title
Measurements
OG001
Week 49, Grade 0
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
Title
Measurements
OG001
Week 52, Grade 1
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
Title
Measurements
OG001
Week 55, Grade 1
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
Title
Measurements
OG001
Week 58, Grade 0
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
Title
Measurements
OG001
Week 61, Grade 0
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
Title
Measurements
OG001
Week 64, Grade 1
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
Title
Measurements
OG001
Week 67, Grade 1
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
Title
Measurements
OG001
Week 70, Grade 1
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
Title
Measurements
OG001
Treatment Discontinuation (up to 97 weeks), Grade 0
ParticipantsOG0006
ParticipantsOG0017
ParticipantsOG0026
Title
Measurements
OG000
Treatment Discontinuation (up to 97 weeks), Grade 1
ParticipantsOG0006
ParticipantsOG0017
ParticipantsOG0026
Title
Measurements
OG000
Treatment Discontinuation (up to 97 weeks), Grade 2
ParticipantsOG0006
ParticipantsOG0017
ParticipantsOG0026
Title
Measurements
OG000
Treatment Discontinuation (up to 97 weeks), Grade 3
ParticipantsOG0006
ParticipantsOG0017
ParticipantsOG0026
Title
Measurements
OG000
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
OG003
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
Units
Counts
Participants
OG00010
OG0017
OG00211
OG00310
Title
Denominators
Categories
Baseline, Grade 0
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
Title
Measurements
OG0004
OG0012
OG0027
OG003
Baseline, Grade 1
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
Week 4, Grade 0
ParticipantsOG00010
ParticipantsOG0016
ParticipantsOG00211
ParticipantsOG0039
Week 4, Grade 1
ParticipantsOG00010
ParticipantsOG0016
ParticipantsOG00211
ParticipantsOG0039
Week 4, Grade 2
ParticipantsOG00010
ParticipantsOG0016
ParticipantsOG00211
ParticipantsOG0039
Week 7, Grade 0
ParticipantsOG0008
ParticipantsOG0014
ParticipantsOG0028
ParticipantsOG0037
Week 7, Grade 1
ParticipantsOG0008
ParticipantsOG0014
ParticipantsOG0028
ParticipantsOG0037
Week 7, Grade 2
ParticipantsOG0008
ParticipantsOG0014
ParticipantsOG0028
ParticipantsOG0037
Week 10, Grade 0
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0026
ParticipantsOG0034
Week 10, Grade 1
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0026
ParticipantsOG0034
Week 10, Grade 2
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0026
ParticipantsOG0034
Week 13, Grade 0
ParticipantsOG0005
ParticipantsOG0012
ParticipantsOG0024
ParticipantsOG0034
Week 13, Grade 1
ParticipantsOG0005
ParticipantsOG0012
ParticipantsOG0024
ParticipantsOG0034
Week 16, Grade 0
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0024
ParticipantsOG0033
Week 16, Grade 1
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0024
ParticipantsOG0033
Week 19, Grade 0
ParticipantsOG0005
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0032
Week 19, Grade 1
ParticipantsOG0005
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0032
Week 22, Grade 0
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0031
Week 22, Grade 1
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0031
Week 25, Grade 0
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0031
Week 25, Grade 1
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0031
Week 28, Grade 0
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0031
Week 28, Grade 1
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0031
Week 31, Grade 0
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0030
Week 34, Grade 0
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0030
Week 37, Grade 0
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Week 37, Grade 1
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Week 40, Grade 0
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Week 40, Grade 1
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Week 43, Grade 0
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Week 43, Grade 1
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Week 46, Grade 0
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Week 46, Grade 1
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Week 49, Grade 0
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Week 49, Grade 2
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Week 52, Grade 0
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 55, Grade 0
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 58, Grade 0
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Treatment Discontinuation (up to 107 weeks), Grade 0
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG003
Treatment Discontinuation (up to 107 weeks), Grade 1
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG003
Treatment Discontinuation (up to 107 weeks), Grade 2
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG003
Treatment Discontinuation (up to 107 weeks), Grade 3
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG003
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG002
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Units
Counts
Participants
OG0006
OG0019
OG0028
Title
Denominators
Categories
Diastolic Blood Pressure, Any Grade Increase
Title
Measurements
OG0000
OG0012
OG0022
Diastolic Blood Pressure, Increase to Grade 2
Title
Measurements
OG0000
OG0011
OG0020
Diastolic Blood Pressure, Increase to Grade 3
Title
Measurements
OG0000
OG0010
OG0021
Systolic Blood Pressure, Any Grade Increase
Title
Measurements
OG0001
OG0012
OG0023
Systolic Blood Pressure, Increase to Grade 2
Title
Measurements
OG0001
OG0012
OG0022
Systolic Blood Pressure, Increase to Grade 3
Title
Measurements
OG0000
OG0010
OG0021
Heart Rate, Decrease to <60 bpm
Title
Measurements
OG0000
OG0010
OG0020
Heart Rate, Change to Normal or No Change
Title
Measurements
OG0004
OG0017
OG0026
Heart Rate, Increase to >100 bpm
Title
Measurements
OG0002
OG0012
OG0022
Temperature, Decrease to <=35 °C
Title
Measurements
OG0000
OG0010
OG0020
Temperature, Change to Normal or No Change
Title
Measurements
OG0006
OG0019
OG0026
Temperature, Increase to >=38 °C
Title
Measurements
OG0000
OG0010
OG0022
OG001
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
OG003
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
Units
Counts
Participants
OG00010
OG0017
OG00211
OG0039
Title
Denominators
Categories
Diastolic Blood Pressure, Any Grade Increase
Title
Measurements
OG0005
OG0011
OG0024
OG0035
Diastolic Blood Pressure, Increase to Grade 2
Title
Measurements
OG0003
OG0010
OG0021
OG003
Diastolic Blood Pressure, Increase to Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Systolic Blood Pressure, Any Grade Increase
Title
Measurements
OG0004
OG0012
OG0025
OG003
Systolic Blood Pressure, Increase to Grade 2
Title
Measurements
OG0001
OG0011
OG0022
OG003
Systolic Blood Pressure, Increase to Grade 3
Title
Measurements
OG0001
OG0010
OG0020
OG003
Heart Rate, Decrease to <60 bpm
Title
Measurements
OG0000
OG0010
OG0020
OG003
Heart Rate, Change to Normal or No Change
Title
Measurements
OG0007
OG0017
OG0029
OG003
Heart Rate, Increase to >100 bpm
Title
Measurements
OG0003
OG0010
OG0022
OG003
Temperature, Decrease to <=35 C
Title
Measurements
OG0000
OG0010
OG0020
OG003
Temperature, Change to Normal or No Change
Title
Measurements
OG00010
OG0016
OG00211
OG003
Temperature, Increase to >=38 C
Title
Measurements
OG0000
OG0011
OG0020
OG003
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
OG003
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
Units
Counts
Participants
OG00010
OG0017
OG00211
OG00310
Title
Denominators
Categories
Title
Measurements
OG00010
OG0017
OG00211
OG00310
OG002
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
OG003
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
Units
Counts
Participants
OG00010
OG0017
OG00211
OG00310
Title
Denominators
Categories
Baseline
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
Title
Measurements
Normal
OG0005
OG0015
OG0025
OG003
Worst-case post baseline
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG0039
OG002
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
OG003
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
Units
Counts
Participants
OG00010
OG0017
OG00211
OG00310
Title
Denominators
Categories
Baseline, Grade 0
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG0039
Title
Measurements
OG00010
OG0016
OG00210
OG003
Baseline, Grade 1
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG0039
Baseline, Grade 2
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG0039
Baseline, Grade 3
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG0039
WCPB, No Grade Increase
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG0039
WCPB, Increase to Grade 2
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG0039
WCPB, Increase to Grade 3
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG0039
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG002
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Units
Counts
Participants
OG0000
OG0011
OG0020
Title
Denominators
Categories
No change or any increase
Title
Measurements
OG0011
Any Decrease
Title
Measurements
OG0010
>=10% Decrease and >= LLN
Title
Measurements
OG0010
>=10% Decrease and < LLN
Title
Measurements
OG0010
>=20% Decrease and >= LLN
Title
Measurements
OG0010
>=20% Decrease and < LLN
Title
Measurements
OG0010
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
OG003
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
Units
Counts
Participants
OG0002
OG0010
OG0022
OG0031
Title
Denominators
Categories
No change or any increase
Title
Measurements
OG0002
OG0020
OG0030
Any Decrease
Title
Measurements
OG0000
OG0022
OG0031
>=10% Decrease and >= LLN
Title
Measurements
OG0000
OG0020
OG0030
>=10% Decrease and < LLN
Title
Measurements
OG0000
OG0020
OG0030
>=20% Decrease and >= LLN
Title
Measurements
OG0000
OG0020
OG0030
>=20% Decrease and < LLN
Title
Measurements
OG0000
OG0020
OG0030
OG001
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG002
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Units
Counts
Participants
OG0006
OG0019
OG0028
Title
Denominators
Categories
Eosinophils, Any Grade Increase
ParticipantsOG0005
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG0001
OG0012
OG0020
Eosinophils, Increase to Grade 3
ParticipantsOG0005
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
Eosinophils, Increase to Grade 4
ParticipantsOG0005
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
Lymphocyte count decreased, Any Grade Increase
ParticipantsOG0005
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
Lymphocyte count decreased, Increase to Grade 3
ParticipantsOG0005
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
Lymphocyte count decreased, Increase to Grade 4
ParticipantsOG0005
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
Lymphocyte count increased, Any Grade Increase
ParticipantsOG0005
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
Lymphocyte count increased, Increase to Grade 3
ParticipantsOG0005
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
Lymphocyte count increased, Increase to Grade 4
ParticipantsOG0005
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
Platelet count decreased, Any Grade Increase
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
Platelet count decreased, Increase to Grade 3
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
Platelet count decreased, Increase to Grade 4
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
White blood cell decreased, Any Grade Increase
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
White blood cell decreased, Increase to Grade 3
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
White blood cell decreased, Increase to Grade 4
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
Anemia, Any Grade Increase
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
Anemia, Increase to Grade 3
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
Anemia, Increase to Grade 4
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
Hemoglobin increased, Any Grade Increase
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
Hemoglobin increased, Increase to Grade 3
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
Hemoglobin increased, Increase to Grade 4
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
Neutrophil count decreased, Any Grade Increase
ParticipantsOG0005
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
Neutrophil count decreased, Increase to Grade 3
ParticipantsOG0005
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
Neutrophil count decreased, Increase to Grade 4
ParticipantsOG0005
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
OG001
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
OG003
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
Units
Counts
Participants
OG00010
OG0017
OG00211
OG00310
Title
Denominators
Categories
Eosinophils, Any Grade Increase
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
Title
Measurements
OG0001
OG0012
OG0023
OG003
Eosinophils, Increase to Grade 3
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
Eosinophils, Increase to Grade 4
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
Lymphocyte count decreased, Any Grade Increase
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG00210
ParticipantsOG00310
Lymphocyte count decreased, Increase to Grade 3
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG00210
ParticipantsOG00310
Lymphocyte count decreased, Increase to Grade 4
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG00210
ParticipantsOG00310
Lymphocyte count increased, Any Grade Increase
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG00210
ParticipantsOG00310
Lymphocyte count increased, Increase to Grade 3
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG00210
ParticipantsOG00310
Lymphocyte count increased, Increase to Grade 4
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG00210
ParticipantsOG00310
Platelet count decreased, Any Grade Increase
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
Platelet count decreased, Increase to Grade 3
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
Platelet count decreased, Increase to Grade 4
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
White blood cell decreased, Any Grade Increase
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
White blood cell decreased, Increase to Grade 3
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG003
White blood cell decreased, Increase to Grade 4
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG003
Anemia, Any Grade Increase
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
Anemia, Increase to Grade 3
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
Anemia, Increase to Grade 4
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
Hemoglobin increased, Any Grade Increase
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
Hemoglobin increased, Increase to Grade 3
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
Hemoglobin increased, Increase to Grade 4
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
Neutrophil count decreased, Any Grade Increase
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
Neutrophil count decreased, Increase to Grade 3
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG003
Neutrophil count decreased, Increase to Grade 4
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG003
OG001
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG002
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Units
Counts
Participants
OG0006
OG0019
OG0028
Title
Denominators
Categories
Activated Partial Thromboplastin Time (aPTT), Any Grade Increase
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG0000
OG0010
OG0020
aPTT, Increase to Grade 3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
aPTT, Increase to Grade 4
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
Glucose, Any Grade Increase
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
Glucose, Increase to Grade 3
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
Glucose, Increase to Grade 4
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
International normalized ratio (INR) increased, Any Grade Increase
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
INR increased, Increase to Grade 3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
INR increased, Increase to Grade 4
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
Alkaline phosphatase (AP), Any Grade Increase
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
AP, Increase to Grade 3
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
AP, Increase to Grade 4
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
Alanine aminotransferase (ALT), Any Grade Increase
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0027
Title
Measurements
OG000
ALT, Increase to Grade 3
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0027
Title
Measurements
OG000
ALT, Increase to Grade 4
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0027
Title
Measurements
OG000
Aspartate aminotransferase (AST), Any Grade Increase
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
AST, Increase to Grade 3
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
AST, Increase to Grade 4
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
Bilirubin, Any Grade Increase
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
Bilirubin, Increase to Grade 3
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
Bilirubin, Increase to Grade 4
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
Creatinine, Any Grade Increase
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
Creatinine, Increase to Grade 3
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
Creatinine, Increase to Grade 4
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
Potassium, Any Grade Increase
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
Potassium, Increase to Grade 3
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
Potassium, Increase to Grade 4
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
Lactate Dehydrogenase, Any Grade Increase
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
Lactate Dehydrogenase, Increase to Grade 3
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
Lactate Dehydrogenase, Increase to Grade 4
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
Sodium, Any Grade Increase
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
Sodium, Increase to Grade 3
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
Sodium, Increase to Grade 4
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
Albumin, Any Grade Increase
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
Albumin, Increase to Grade 3
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
Albumin, Increase to Grade 4
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0028
Title
Measurements
OG000
OG001
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
OG003
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
Units
Counts
Participants
OG00010
OG0017
OG00211
OG00310
Title
Denominators
Categories
aPTT, Any Grade Increase
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Title
Measurements
OG0000
OG0010
OG0020
OG003
aPTT, Increase to Grade 3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
aPTT, Increase to Grade 4
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Glucose, Any Grade Increase
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG0039
Glucose, Increase to Grade 3
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG0039
Glucose, Increase to Grade 4
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG0039
INR increased, Any Grade Increase
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
INR increased, Increase to Grade 3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
INR increased, Increase to Grade 4
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
AP, Any Grade Increase
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
AP, Increase to Grade 3
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
AP, Increase to Grade 4
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
ALT, Any Grade Increase
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
ALT, Increase to Grade 3
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
ALT, Increase to Grade 4
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
AST, Any Grade Increase
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
AST, Increase to Grade 3
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
AST, Increase to Grade 4
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
Bilirubin, Any Grade Increase
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
Bilirubin, Increase to Grade 3
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
Bilirubin, Increase to Grade 4
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
Creatinine, Any Grade Increase
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
Creatinine, Increase to Grade 3
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
Creatinine, Increase to Grade 4
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
Potassium, Any Grade Increase
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
Potassium, Increase to Grade 3
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
Potassium, Increase to Grade 4
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
Lactate Dehydrogenase, Any Grade Increase
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
Lactate Dehydrogenase, Increase to Grade 3
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
Lactate Dehydrogenase, Increase to Grade 4
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
Sodium, Any Grade Increase
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
Sodium, Increase to Grade 3
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
Sodium, Increase to Grade 4
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
Albumin, Any Grade Increase
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
Albumin, Increase to Grade 3
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
Albumin, Increase to Grade 4
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
OG001
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG002
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Units
Counts
Participants
OG0006
OG0019
OG0029
Title
Denominators
Categories
Calcium, B High, WCPB High
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0029
Title
Measurements
OG0000
OG0011
OG0021
Calcium, B High, WCPB Normal
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0029
Title
Measurements
OG000
Calcium, B High, WCPB Low
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0029
Title
Measurements
OG000
Calcium, B Normal, WCPB High
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0029
Title
Measurements
OG000
Calcium, B Normal, WCPB Normal
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0029
Title
Measurements
OG000
Calcium, B Normal, WCPB Low
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0029
Title
Measurements
OG000
Calcium, B Low, WCPB High
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0029
Title
Measurements
OG000
Calcium, B Low, WCPB Normal
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0029
Title
Measurements
OG000
Calcium, B Low, WCPB Low
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0029
Title
Measurements
OG000
Lipase, B High, WCPB High
ParticipantsOG0005
ParticipantsOG0017
ParticipantsOG0027
Title
Measurements
OG000
Lipase, B High, WCPB Normal
ParticipantsOG0005
ParticipantsOG0017
ParticipantsOG0027
Title
Measurements
OG000
Lipase, B High, WCPB Low
ParticipantsOG0005
ParticipantsOG0017
ParticipantsOG0027
Title
Measurements
OG000
Lipase, B Normal, WCPB High
ParticipantsOG0005
ParticipantsOG0017
ParticipantsOG0027
Title
Measurements
OG000
Lipase, B Normal, WCPB Normal
ParticipantsOG0005
ParticipantsOG0017
ParticipantsOG0027
Title
Measurements
OG000
Lipase, B Normal, WCPB Low
ParticipantsOG0005
ParticipantsOG0017
ParticipantsOG0027
Title
Measurements
OG000
Lipase, B Low, WCPB High
ParticipantsOG0005
ParticipantsOG0017
ParticipantsOG0027
Title
Measurements
OG000
Lipase, B Low, WCPB Normal
ParticipantsOG0005
ParticipantsOG0017
ParticipantsOG0027
Title
Measurements
OG000
Lipase, B Low, WCPB Low
ParticipantsOG0005
ParticipantsOG0017
ParticipantsOG0027
Title
Measurements
OG000
Amylase, B High, WCPB High
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0027
Title
Measurements
OG000
Amylase, B High, WCPB Normal
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0027
Title
Measurements
OG000
Amylase, B High, WCPB Low
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0027
Title
Measurements
OG000
Amylase, B Normal, WCPB High
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0027
Title
Measurements
OG000
Amylase, B Normal, WCPB Normal
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0027
Title
Measurements
OG000
Amylase, B Normal, WCPB Low
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0027
Title
Measurements
OG000
Amylase, B Low, WCPB High
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0027
Title
Measurements
OG000
Amylase, B Low, WCPB Normal
ParticipantsOG0005
ParticipantsOG0019
ParticipantsOG0027
Title
Measurements
OG000
Amylase, B Low, WCPB Low
ParticipantsOG0005
ParticipantsOG0019
ParticipantsOG0027
Title
Measurements
OG000
Urea, B High, WCPB High
ParticipantsOG0004
ParticipantsOG0015
ParticipantsOG0026
Title
Measurements
OG000
Urea, B High, WCPB Normal
ParticipantsOG0004
ParticipantsOG0015
ParticipantsOG0026
Title
Measurements
OG000
Urea, B High, WCPB Low
ParticipantsOG0004
ParticipantsOG0015
ParticipantsOG0026
Title
Measurements
OG000
Urea, B Normal, WCPB High
ParticipantsOG0004
ParticipantsOG0015
ParticipantsOG0026
Title
Measurements
OG000
Urea, B Normal, WCPB Normal
ParticipantsOG0004
ParticipantsOG0015
ParticipantsOG0026
Title
Measurements
OG000
Urea, B Normal, WCPB Low
ParticipantsOG0004
ParticipantsOG0015
ParticipantsOG0026
Title
Measurements
OG000
Urea, B Low, WCPB High
ParticipantsOG0004
ParticipantsOG0015
ParticipantsOG0026
Title
Measurements
OG000
Urea, B Low, WCPB Normal
ParticipantsOG0004
ParticipantsOG0015
ParticipantsOG0026
Title
Measurements
OG000
Urea, B Low, WCPB Low
ParticipantsOG0004
ParticipantsOG0015
ParticipantsOG0026
Title
Measurements
OG000
Free Triiodothyronine (T3), B High, WCPB High
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG0026
Title
Measurements
OG000
T3, B High, WCPB Normal
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG0026
Title
Measurements
OG000
T3, B High, WCPB Low
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG0026
Title
Measurements
OG000
T3, B Normal, WCPB High
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG0026
Title
Measurements
OG000
T3, B Normal, WCPB Normal
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG0026
Title
Measurements
OG000
T3, B Normal, WCPB Low
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG0026
Title
Measurements
OG000
T3, B Low, WCPB High
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG0026
Title
Measurements
OG000
T3, B Low, WCPB Normal
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG0026
Title
Measurements
OG000
T3, B Low, WCPB Low
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG0026
Title
Measurements
OG000
Free Thyroxine (T4), B High, WCPB High
ParticipantsOG0004
ParticipantsOG0017
ParticipantsOG0026
Title
Measurements
OG000
T4, B High, WCPB Normal
ParticipantsOG0004
ParticipantsOG0017
ParticipantsOG0026
Title
Measurements
OG000
T4, B High, WCPB Low
ParticipantsOG0004
ParticipantsOG0017
ParticipantsOG0026
Title
Measurements
OG000
T4, B Normal, WCPB High
ParticipantsOG0004
ParticipantsOG0017
ParticipantsOG0026
Title
Measurements
OG000
T4, B Normal, WCPB Normal
ParticipantsOG0004
ParticipantsOG0017
ParticipantsOG0026
Title
Measurements
OG000
T4, B Normal, WCPB Low
ParticipantsOG0004
ParticipantsOG0017
ParticipantsOG0026
Title
Measurements
OG000
T4, B Low, WCPB High
ParticipantsOG0004
ParticipantsOG0017
ParticipantsOG0026
Title
Measurements
OG000
T4, B Low, WCPB Normal
ParticipantsOG0004
ParticipantsOG0017
ParticipantsOG0026
Title
Measurements
OG000
T4, B Low, WCPB Low
ParticipantsOG0004
ParticipantsOG0017
ParticipantsOG0026
Title
Measurements
OG000
Troponin I, B High, WCPB High
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0023
Title
Measurements
OG000
Troponin I, B High, WCPB Normal
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0023
Title
Measurements
OG000
Troponin I, B High, WCPB Low
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0023
Title
Measurements
OG000
Troponin I, B Normal, WCPB High
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0023
Title
Measurements
OG000
Troponin I, B Normal, WCPB Normal
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0023
Title
Measurements
OG000
Troponin I, B Normal, WCPB Low
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0023
Title
Measurements
OG000
Troponin I, B Low, WCPB High
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0023
Title
Measurements
OG000
Troponin I, B Low, WCPB Normal
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0023
Title
Measurements
OG000
Troponin I, B Low, WCPB Low
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0023
Title
Measurements
OG000
Thyrotropin, B High, WCPB High
ParticipantsOG0005
ParticipantsOG0017
ParticipantsOG0027
Title
Measurements
OG000
Thyrotropin, B High, WCPB Normal
ParticipantsOG0005
ParticipantsOG0017
ParticipantsOG0027
Title
Measurements
OG000
Thyrotropin, B High, WCPB Low
ParticipantsOG0005
ParticipantsOG0017
ParticipantsOG0027
Title
Measurements
OG000
Thyrotropin, B Normal, WCPB High
ParticipantsOG0005
ParticipantsOG0017
ParticipantsOG0027
Title
Measurements
OG000
Thyrotropin, B Normal, WCPB Normal
ParticipantsOG0005
ParticipantsOG0017
ParticipantsOG0027
Title
Measurements
OG000
Thyrotropin, B Normal, WCPB Low
ParticipantsOG0005
ParticipantsOG0017
ParticipantsOG0027
Title
Measurements
OG000
Thyrotropin, B Low, WCPB High
ParticipantsOG0005
ParticipantsOG0017
ParticipantsOG0027
Title
Measurements
OG000
Thyrotropin, B Low, WCPB Normal
ParticipantsOG0005
ParticipantsOG0017
ParticipantsOG0027
Title
Measurements
OG000
Thyrotropin, B Low, WCPB Low
ParticipantsOG0005
ParticipantsOG0017
ParticipantsOG0027
Title
Measurements
OG000
OG001
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
OG003
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
Units
Counts
Participants
OG00010
OG0017
OG00211
OG00310
Title
Denominators
Categories
Calcium, B High, WCPB High
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
Title
Measurements
OG0000
OG0010
OG0020
OG003
Calcium, B High, WCPB Normal
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
Calcium, B High, WCPB Low
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
Calcium, B Normal, WCPB High
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
Calcium, B Normal, WCPB Normal
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
Calcium, B Normal, WCPB Low
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
Calcium, B Low, WCPB High
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
Calcium, B Low, WCPB Normal
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
Calcium, B Low, WCPB Low
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00211
ParticipantsOG00310
Lipase, B High, WCPB High
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG00210
ParticipantsOG0039
Lipase, B High, WCPB Normal
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG00210
ParticipantsOG0039
Lipase, B High, WCPB Low
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG00210
ParticipantsOG0039
Lipase, B Normal, WCPB High
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG00210
ParticipantsOG0039
Lipase, B Normal, WCPB Normal
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG00210
ParticipantsOG0039
Lipase, B Normal, WCPB Low
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG00210
ParticipantsOG0039
Lipase, B Low, WCPB High
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG00210
ParticipantsOG0039
Lipase, B Low, WCPB Normal
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG00210
ParticipantsOG0039
Lipase, B Low, WCPB Low
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG00210
ParticipantsOG0039
Amylase, B High, WCPB High
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG00210
ParticipantsOG0039
Amylase, B High, WCPB Normal
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00210
ParticipantsOG0039
Amylase, B High, WCPB Low
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00210
ParticipantsOG0039
Amylase, B Normal, WCPB High
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG00210
ParticipantsOG0039
Amylase, B Normal, WCPB Normal
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG00210
ParticipantsOG0039
Amylase, B Normal, WCPB Low
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG00210
ParticipantsOG0039
Amylase, B Low, WCPB High
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG00210
ParticipantsOG0039
Amylase, B Low, WCPB Normal
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG00210
ParticipantsOG0039
Amylase, B Low, WCPB Low
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG00210
ParticipantsOG0039
Urea, B High, WCPB High
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0038
Urea, B High, WCPB Normal
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0038
Urea, B High, WCPB Low
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0038
Urea, B Normal, WCPB High
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0038
Urea, B Normal, WCPB Normal
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0038
Urea, B Normal, WCPB Low
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0038
Urea, B Low, WCPB High
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0038
Urea, B Low, WCPB Normal
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0038
Urea, B Low, WCPB Low
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0038
Free Triiodothyronine (T3), B High, WCPB High
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0039
T3, B High, WCPB Normal
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0039
T3, B High, WCPB Low
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0039
T3, B Normal, WCPB High
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0039
T3, B Normal, WCPB Normal
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0039
T3, B Normal, WCPB Low
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0039
T3, B Low, WCPB High
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0039
T3, B Low, WCPB Normal
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0039
T3, B Low, WCPB Low
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0039
Free Thyroxine (T4), B High, WCPB High
ParticipantsOG0008
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0039
T4, B High, WCPB Normal
ParticipantsOG0008
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0039
T4, B High, WCPB Low
ParticipantsOG0008
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0039
T4, B Normal, WCPB High
ParticipantsOG0008
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0039
T4, B Normal, WCPB Normal
ParticipantsOG0008
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0039
T4, B Normal, WCPB Low
ParticipantsOG0008
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0039
T4, B Low, WCPB High
ParticipantsOG0008
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0039
T4, B Low, WCPB Normal
ParticipantsOG0008
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0039
T4, B Low, WCPB Low
ParticipantsOG0008
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0039
Troponin I, B High, WCPB High
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0026
ParticipantsOG0036
Troponin I, B High, WCPB Normal
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0026
ParticipantsOG0036
Troponin I, B High, WCPB Low
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0026
ParticipantsOG0036
Troponin I, B Normal, WCPB High
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0026
ParticipantsOG0036
Troponin I, B Normal, WCPB Normal
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0026
ParticipantsOG0036
Troponin I, B Normal, WCPB Low
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0026
ParticipantsOG0036
Troponin I, B Low, WCPB High
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0026
ParticipantsOG0036
Troponin I, B Low, WCPB Normal
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0026
ParticipantsOG0036
Troponin I, B Low, WCPB Low
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0026
ParticipantsOG0036
Thyrotropin, B High, WCPB High
ParticipantsOG0009
ParticipantsOG0015
ParticipantsOG0029
ParticipantsOG0039
Thyrotropin, B High, WCPB Normal
ParticipantsOG0009
ParticipantsOG0015
ParticipantsOG0029
ParticipantsOG0039
Thyrotropin, B High, WCPB Low
ParticipantsOG0009
ParticipantsOG0015
ParticipantsOG0029
ParticipantsOG0039
Thyrotropin, B Normal, WCPB High
ParticipantsOG0009
ParticipantsOG0015
ParticipantsOG0029
ParticipantsOG0039
Thyrotropin, B Normal, WCPB Normal
ParticipantsOG0009
ParticipantsOG0015
ParticipantsOG0029
ParticipantsOG0039
Thyrotropin, B Normal, WCPB Low
ParticipantsOG0009
ParticipantsOG0015
ParticipantsOG0029
ParticipantsOG0039
Thyrotropin, B Low, WCPB High
ParticipantsOG0009
ParticipantsOG0015
ParticipantsOG0029
ParticipantsOG0039
Thyrotropin, B Low, WCPB Normal
ParticipantsOG0009
ParticipantsOG0015
ParticipantsOG0029
ParticipantsOG0039
Thyrotropin, B Low, WCPB Low
ParticipantsOG0009
ParticipantsOG0015
ParticipantsOG0029
ParticipantsOG0039
OG002
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
OG003
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug MD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
OG004
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
OG006
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG002
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
OG003
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
Units
Counts
Participants
OG00010
OG0017
OG00211
OG00310
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 30.8)
OG0010(0.0 to 41.0)
OG0029(0.2 to 41.3)
OG0030(0.0 to 30.8)
OG002
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
OG003
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
Units
Counts
Participants
OG00010
OG0017
OG00211
OG00310
Title
Denominators
Categories
Title
Measurements
OG00040(12.2 to 73.8)
OG00114(0.4 to 57.9)
OG00227(6.0 to 61.0)
OG0030(0.0 to 30.8)
OG002
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
OG003
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
Units
Counts
Participants
OG00010
OG0017
OG00210
OG00310
Title
Denominators
Categories
Cmax
Title
Measurements
OG000126.386± 21.8676
OG001137.837± 34.5390
OG002153.377± 33.5154
OG00322.967± 7.0701
Cmin
Title
Measurements
OG00019.408± 6.4103
OG00120.752± 11.5836
OG002153.069± 54.3450
OG003
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
OG003
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
OG003
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug MD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
OG004
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
OG006
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG001
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG002
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug MD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
OG004
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
OG006
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG002
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug MD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
OG004
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
OG006
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG002
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug MD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
OG004
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
OG006
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG002
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug MD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
OG004
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
OG006
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG002
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug MD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
OG004
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
OG006
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG002
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug MD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
OG004
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
OG006
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG002
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug MD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
OG004
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
OG006
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG002
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug MD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
OG004
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
OG006
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG002
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug MD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
OG004
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
OG006
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
OG002
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug MD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
OG004
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
OG006
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug MD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
OG004
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
OG006
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug MD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
OG004
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
OG006
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug MD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
OG004
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
OG006
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug MD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
OG004
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
OG006
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.