Tusamitamab Ravtansine (SAR408701) in Combination With Pe... | NCT04524689 | Trialant
NCT04524689
Sponsor
Sanofi
Status
Terminated
Last Update Posted
Oct 29, 2025Actual
Enrollment
57Actual
Phase
Phase 2
Conditions
Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC)
Interventions
SAR408701 (Tusamitamab ravtansine)
Pembrolizumab
Cisplatin
Carboplatin
Pemetrexed
Countries
United States
Brazil
Chile
Czechia
France
Hungary
Israel
Spain
Protocol Section
Identification Module
NCT ID
NCT04524689
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
ACT16146
Secondary IDs
ID
Type
Description
Link
U1111-1233-9798
Registry Identifier
ICTRP
2023-509115-84
Registry Identifier
CTIS
Brief Title
Tusamitamab Ravtansine (SAR408701) in Combination With Pembrolizumab and Tusamitamab Ravtansine (SAR408701) in Combination With Pembrolizumab and Platinum-based Chemotherapy With or Without Pemetrexed in Patients With NSQ NSCLC
Official Title
Open-label, Phase 2 Study of Tusamitamab Ravtansine (SAR408701) Combined With Pembrolizumab and Tusamitamab Ravtansine (SAR408701) Combined With Pembrolizumab and Platinum-based Chemotherapy With or Without Pemetrexed in Patients With CEACAM5 Positive Expression Advanced/Metastatic Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC)
Acronym
CARMEN-LC05
Organization
SanofiINDUSTRY
Status Module
Record Verification Date
Sep 2025
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Sponsor decision, the decision is not related to any safety concern.
Expanded Access Info
No
Start Date
Oct 26, 2020Actual
Primary Completion Date
Mar 12, 2024Actual
Completion Date
Dec 24, 2024Actual
First Submitted Date
Aug 20, 2020
First Submission Date that Met QC Criteria
Aug 20, 2020
First Posted Date
Aug 24, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Feb 5, 2025
Results First Submitted that Met QC Criteria
Mar 7, 2025
Results First Posted Date
Mar 17, 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
Oct 12, 2025
Last Update Posted Date
Oct 29, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
SanofiINDUSTRY
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
Primary Objective:
Safety run-in part: to assess the tolerability and to determine the recommended doses of tusamitamab ravtansine in combination with pembrolizumab and tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy with or without pemetrexed to be tested in the expansion part of the study in the NSQ NSCLC population
Expansion part (including participants treated at the recommended dose for expansion [RDE] from the Safety Run-in part): to assess the antitumor activity of several dose levels (DLs; if applicable) of tusamitamab ravtansine in combination with pembrolizumab and of several DLs of tusamitamab ravtansine in combination with pembrolizumab, platinum-based chemotherapy, and pemetrexed in the NSQ NSCLC population
Secondary Objectives:
To assess the safety and tolerability of several DLs (if applicable) of tusamitamab ravtansine in combination with pembrolizumab and of 1 DL of tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy, and of several DLs of tusamitamab ravtansine in combination with pembrolizumab, and platinum-based chemotherapy with pemetrexed in the NSQ NSCLC population
To assess the antitumor activity of several DLs (if applicable) of tusamitamab ravtansine in combination with pembrolizumab and of 1 DL of tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy, and of several DLs of tusamitamab ravtansine in combination with pembrolizumab, platinum-based chemotherapy, and pemetrexed in the NSQ NSCLC population
To assess the durability of the response to treatment with several DLs (if applicable) of tusamitamab ravtansine in combination with pembrolizumab and of 1 DL of tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy, and of several DLs of tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy, and pemetrexed in the NSQ NSCLC population
To assess the antitumor activity of tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy in the NSQ NSCLC population
To assess the pharmacokinetics (PK) of tusamitamab ravtansine, pembrolizumab, pemetrexed, cisplatin, and carboplatin, each when given in combination as a doublet (tusamitamab ravtansine + pembrolizumab) or a triplet (tusamitamab ravtansine + pembrolizumab + platinum-based chemotherapy) or a quadruplet (tusamitamab ravtansine + pembrolizumab + platinum-based chemotherapy + pemetrexed)
To assess the immunogenicity of tusamitamab ravtansine in combination with pembrolizumab and tusamitamab ravtansine in combination with pembrolizumab and platinum based chemotherapy with or without pemetrexed
Detailed Description
The expected duration of study intervention for participants may vary, based on disease progression date; median expected duration of study per participant is estimated at 10 months (up to 1 month for screening, a median of 6 months for treatment, a median of 1 month for EOT, and follow-up visit 90 days after the last IMP administration).
Conditions Module
Conditions
Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC)
Keywords
Not provided
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
57Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Tusamitamab ravtasine 150 mg/m^2 + Pembrolizumab
Experimental
Pembrolizumab dose will be administered intravenously prior to intravenous administration of tusamitamab ravtansine dose every 3 weeks.
Drug: SAR408701 (Tusamitamab ravtansine)
Drug: Pembrolizumab
Tusamitamab ravtasine 170 mg/m^2 + Pembrolizumab
Experimental
Pembrolizumab dose will be administered intravenously prior to intravenous administration of tusamitamab ravtansine dose every 3 weeks.
Drug: SAR408701 (Tusamitamab ravtansine)
Drug: Pembrolizumab
Tusamitamab ravtansine 150 mg/m^2 + Pembrolizumab + carboplatin or cisplatin
Experimental
Pembrolizumab dose will be administered intravenously prior to intravenous adminstration of tusamitamab ravtansine dose every 3 weeks. Carboplatin will be infused over 15 to 60 minutes immediately after tusamitamab ravtansine infusion on Day 1 and Q3W for the first 4 cycles. Cisplatin will be infused approximately 30 minutes after tusamitamab ravtansine infusion on Day 1 and Q3W for the first 4 cycles.
Drug: SAR408701 (Tusamitamab ravtansine)
Drug: Pembrolizumab
Drug: Cisplatin
Drug: Carboplatin
Tusamitamab ravtansine 170 mg/m^2 + Pembrolizumab + carboplatin or cisplatin
Experimental
Pembrolizumab dose will be administered intravenously prior to intravenous adminstration of tusamitamab ravtansine dose every 3 weeks. Carboplatin will be infused over 15 to 60 minutes immediately after tusamitamab ravtansine infusion on Day 1 and Q3W for the first 4 cycles. Cisplatin will be infused approximately 30 minutes after tusamitamab ravtansine infusion on Day 1 and Q3W for the first 4 cycles.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
SAR408701 (Tusamitamab ravtansine)
Drug
Pharmaceutical form:Concentrate for solution for infusion Route of administration: Intravenous
Tusamitamab ravtansine 150 mg/m^2 + Pembrolizumab + carboplatin or cisplatin
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
All Cohorts: Number of Participants With Study Drug-Related Dose-Limiting Toxicities (DLTs)
DLTs were defined as: a) Hematological abnormalities: grade 4 neutropenia for 7 or more consecutive days, grade 3 to 4 neutropenia complicated by fever (temperature ≥38.5 degree Celsius on more than 1 occasion) or microbiologically or radiographically documented infection, grade ≥3 thrombocytopenia associated with clinically significant bleeding requiring clinical intervention; b) Non-hematological abnormalities: grade 4 non-hematologic adverse event (AE), except AE symptoms related to the underlying disease as per the Investigator's judgment, grade ≥3 keratopathy. In addition, any other AE that the recruiting Investigators and sponsor deemed to be dose-limiting, regardless of its grade, was also considered as DLT.
Cycle 1 Day 1 up to Cycle 1 Day 21 (cycle duration=3 weeks)
Doublet Cohort: Objective Response Rate (ORR)
ORR was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) as best overall response (BOR) per response evaluation criteria in solid tumors (RECIST) version (v) 1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Tumor assessments performed at baseline, then every 6 weeks for first 24 weeks, and every 9 weeks thereafter, approximately 158.4 weeks
Quadruplet Cohort: Objective Response Rate
ORR was defined as the percentage of participants with a confirmed CR or PR as per RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Tumor assessments performed at baseline, then every 6 weeks for first 24 weeks, and every 9 weeks thereafter, approximately 139.9 weeks
Secondary Outcomes
Measure
Description
Time Frame
All Cohorts: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. A serious AE was defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity or was a congenital anomaly/birth defect. A TEAE was defined as an AE that developed, worsened or became serious during the treatment-emergent period.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion criteria :
Histologically- or cytologically-confirmed diagnosis of advanced or metastatic NSQ NSCLC with no EGFR sensitizing mutation or BRAF mutation or ALK/ROS alterations.
No prior systemic chemotherapy for the treatment of the participant's advanced or metastatic disease (treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as completed at least 6 months prior to diagnosis of advanced or metastatic disease).
Expression of CEACAM5 as demonstrated prospectively by a centrally assessed Immunohistochemistry (IHC) assay of ≥2+ in intensity involving at least 1% of the tumor cell population in archival tumor sample (or if not available fresh biopsy sample).
Measurable disease based on RECIST 1.1.
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
Life expectancy of at least 3 months
Exclusion criteria:
Medical condition requiring concomitant administration of a medication with a strong CYP3A inhibitor.
Uncontrolled brain metastases and history of leptomeningeal disease.
Significant concomitant illness, including any severe medical condition that, in the opinion of the investigator or Sponsor, would impair the patient's participation in the study or interpretation of the results.
History within the last 3 years of an invasive malignancy other than the one treated in this study, with the exception of resected/ablated basal or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix, or other local tumors considered cured by local treatment.
History of known acquired immunodeficiency syndrome (AIDS) related illnesses or known HIV disease requiring antiretroviral treatment, or active hepatitis A, B, or C infection.
History of active autoimmune disease that has required systemic treatment in the past 2 years.
History of allogeneic tissue/solid organ transplantation.
Active infection requiring IV systemic therapy within 2 weeks prior to randomization or active tuberculosis.
Interstitial lung disease or history of pneumonitis that has required oral or IV steroids
Non-resolution of any prior treatment-related toxicity to < Grade 2 according to NCI CTCAE V5.0, with the exception of alopecia, vitiligo, or active thyroiditis controlled with hormone replacement therapy.
Unresolved corneal disorder or any previous corneal disorder considered by an ophthalmologist to predict higher risk of drug-induced keratopathy. The use of contact lenses is not permitted.
Symptomatic herpes zoster within 3 months prior to screening.
Significant allergies to humanized monoclonal antibodies.
Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A [IgA] dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).
Concurrent treatment with any other anticancer therapy.
Have received prior chemotherapy treatment for advanced/metastatic NSCLC.
The patient is a candidate for a curative treatment with either surgical resection and/or chemoradiation
Washout period before the first administration of study intervention of less than 3 weeks or less than 5 times the half-life, whichever is shorter, for any investigational treatment).
Any prior therapy targeting CEACAM5.
Any prior treatment with any other anti-PD-1, or PD-L1 or programmed death ligand 2 (PD-L2), anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4.
Any prior maytansinoid treatment (DM1 or DM4 ADC).
Is receiving systemic steroid therapy ≤3 days prior to the first dose of study therapy or receiving any other form of immunosuppressive medication. Daily steroid replacement therapy or any corticosteroid premedication if applicable are allowed.
Any radiation therapy to lung >30 Gy within 6 months of first study intervention administration.
Has received or will receive a live vaccine within 30 days prior to the first study intervention administration.
Any major surgery within the preceding 3 weeks of the first study intervention administration.
Prior/concurrent clinical study experience
Current participation in any other clinical study involving an investigational study treatment or any other type of medical research.
Poor organ function
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Clinical Sciences & Operations
Sanofi
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
KU Medical Center_Investigational Site Number :8400002
Westwood
Kansas
66205
United States
Centro Avancado de Oncologia CECAN - Liga Contra o Cancer Site Number : 0760004
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
A total of 57 participants were enrolled in either Part A [doublet cohort (tusamitamab ravtansine + pembrolizumab)], Part B [triplet cohort (tusamitamab ravtansine + pembrolizumab + platinum-based chemotherapy i.e., cisplatin or carboplatin)] or Part C [quadruplet cohort (tusamitamab ravtansine + pembrolizumab + platinum-based chemotherapy + pemetrexed)] of the study per Investigator's choice.
Recruitment Details
The study was conducted at 22 centers in 8 countries. A total of 68 participants were screened from 26 October 2020 to 19 December 2023, of which 11 were screen failures. Screen failures were mainly due to not meeting the eligibility criteria. The study was terminated due to the discontinuation of the overall development of tusamitamab ravtansine by the Sponsor.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab
In Part A (doublet cohort), participants received tusamitamab ravtansine 150 milligram per square meter (mg/m^2) along with pembrolizumab 200 milligram (mg) via intravenous (IV) infusion on Day 1 and then every 3 weeks (Q3W) until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
Pembrolizumab dose will be administered intravenously prior to intravenous adminstration of tusamitamab ravtansine dose every 3 weeks. Pemetrexed will be infused over 10 minutes after tusamitamab ravtansine infusion on Day 1 and then Q3W. Carboplatin will be infused over 15 to 60 minutes immediately after pemetrexed infusion on Day 1 and Q3W for the first 4 cycles. Cisplatin will be infused approximately 30 minutes after pemetrexed infusion after pemetrexed infusion on Day 1 and Q3W for the first 4 cycles.
Pembrolizumab dose will be administered intravenously prior to intravenous adminstration of tusamitamab ravtansine dose every 3 weeks. Pemetrexed will be infused over 10 minutes after tusamitamab ravtansine infusion on Day 1 and then Q3W. Carboplatin will be infused over 15 to 60 minutes immediately after pemetrexed infusion on Day 1 and Q3W for the first 4 cycles. Cisplatin will be infused approximately 30 minutes after pemetrexed infusion after pemetrexed infusion on Day 1 and Q3W for the first 4 cycles.
From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet)
Doublet and Quadruplet Cohorts: Progression-free Survival (PFS)
PFS was defined as the time from the first study treatment administration to the date of the first documented progressive disease (PD) or death due to any cause, whichever came first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of 1 or more new lesions was also considered progression.
Tumor assessments performed at baseline, then every 6 weeks for first 24 weeks, and every 9 weeks thereafter, approximately 158.4 weeks (doublet) and 139.9 weeks (quadruplet)
All Cohorts: Disease Control Rate (DCR)
DCR was defined as percentage of participants with a confirmed CR, confirmed PR or stable disease (SD) as BOR per RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage from the baseline study to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of 1 or more new lesions was also considered progression.
Tumor assessments performed at baseline, then every 6 weeks for first 24 weeks, and every 9 weeks thereafter, approximately 158.4 weeks (doublet), 113 weeks (triplet), and 139.9 weeks (quadruplet)
All Cohorts: Duration of Response (DOR)
DOR was defined as the time from first documented evidence of CR or PR until PD determined per RECIST v1.1 or death from any cause, whichever occurred first. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of 1 or more new lesions was also considered progression.
Tumor assessments performed at baseline, then every 6 weeks for first 24 weeks, and every 9 weeks thereafter, approximately 158.4 weeks (doublet), 113 weeks (triplet), and 139.9 weeks (quadruplet)
Triplet Cohort: Objective Response Rate
ORR was defined as the percentage of participants with a confirmed CR or PR as per RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Tumor assessments performed at baseline, then every 6 weeks for first 24 weeks, and every 9 weeks thereafter, approximately 113 weeks
All Cohorts: Trough Concentration (Ctrough) of Tusamitamab Ravtansine
Blood samples were collected for the measurement of tusamitamab ravtansine concentrations.
Pre-dose on Day 1 of Cycle 2 (cycle duration=3 weeks)
All Cohorts: Ctrough of Pembrolizumab
Blood samples were collected for the measurement of pembrolizumab concentrations.
Pre-dose on Day 1 of Cycle 2 (cycle duration=3 weeks)
Quadruplet Cohort: Plasma Concentration of Pemetrexed
Blood samples were collected for the measurement of pemetrexed concentrations.
30 minutes post-dose on Day 1 of Cycle 1 (cycle duration=3 weeks)
Triplet and Quadruplet Cohorts: Total Plasma Concentration Observed at the End of Infusion (Ceoi) of Cisplatin
Blood samples were collected for the measurement of cisplatin concentrations.
At end of infusion on Day 1 of Cycle 1 (cycle duration=3 weeks)
Triplet and Quadruplet Cohorts: Total Plasma Concentration Observed at the End of Infusion of Carboplatin
Blood samples were collected for the measurement of carboplatin concentrations.
At end of infusion on Day 1 of Cycle 1 (cycle duration=3 weeks)
All Cohorts: Number of Participants With Treatment-emergent Anti-Therapeutic Antibodies (ATAs) Against Tusamitamab Ravtansine
Blood samples were collected to assess the presence of treatment-emergent ATA against tusamitamab ravtansine. ATA incidence was defined as the number of participants found to have treatment-emergent ATA response during the study.
From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet)
Natal
Rio Grande do Norte
59062-000
Brazil
Centro de Investigacion y Desarrollo Oncologico (CIDO) Hochstetter 599 of. 602-603-1001, Temuco_Investigational Site Number :1520005
Temuco
La AraucanÃa
4780000
Chile
ONCOCENTRO APYS Av. La Marina 1702, 2do piso, Viña del Mar_Investigational Site Number :1520003
Viña del Mar
Valparaiso
2520598
Chile
Orlandi Oncologia General Salvo 159, Providencia_Investigational Site Number :1520002
Santiago
7500713
Chile
ICEGCLINIC Avenida SerafÃn Zamora 190 Torre B, piso 4. La Florida_Investigational Site Number :1520006
Santiago
8241470
Chile
Fakultnà nemocnice Olomouc Onkologická klinika I.P. Pavlova 6_Site Number :2030001
In Part A (doublet cohort), participants received tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
In Part B (triplet cohort), participants received tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m^2 or carboplatin area under the curve (AUC) 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
In Part B (triplet cohort), participants received tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
In Part C (quadruplet cohort), participants received tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m^2, and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
In Part C (quadruplet cohort), participants received tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m^2, and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
FG00023 subjects
FG0012 subjects
FG0026 subjects
FG0031 subjects
FG00422 subjects
FG0053 subjects
COMPLETED
FG0007 subjects
FG0011 subjects
FG0024 subjects
FG0031 subjects
FG00416 subjects
FG0052 subjects
NOT COMPLETED
FG00016 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG0046 subjects
FG0051 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0042 subjects
FG0050 subjects
Study terminated by Sponsor
FG0006 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Not related to Coronavirus disease 2019
FG0009 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
All-treated population included all participants assigned to study treatment and who actually received at least 1 dose of study treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab
In Part A (doublet cohort), participants received tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
BG001
Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab
In Part A (doublet cohort), participants received tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
In Part B (triplet cohort), participants received tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
In Part B (triplet cohort), participants received tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
In Part C (quadruplet cohort), participants received tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m^2, and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
In Part C (quadruplet cohort), participants received tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m^2, and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00023
BG0012
BG0026
BG0031
BG00422
BG0053
BG00657
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
< 65 years
BG00010
BG0010
BG0023
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00011
BG0011
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
White
BG00020
BG0012
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
All Cohorts: Number of Participants With Study Drug-Related Dose-Limiting Toxicities (DLTs)
DLTs were defined as: a) Hematological abnormalities: grade 4 neutropenia for 7 or more consecutive days, grade 3 to 4 neutropenia complicated by fever (temperature ≥38.5 degree Celsius on more than 1 occasion) or microbiologically or radiographically documented infection, grade ≥3 thrombocytopenia associated with clinically significant bleeding requiring clinical intervention; b) Non-hematological abnormalities: grade 4 non-hematologic adverse event (AE), except AE symptoms related to the underlying disease as per the Investigator's judgment, grade ≥3 keratopathy. In addition, any other AE that the recruiting Investigators and sponsor deemed to be dose-limiting, regardless of its grade, was also considered as DLT.
DLT-evaluable population included participants who received 1 cycle with at least 80% of the intended dose for each study treatment of the combination during the safety run-in at both doses of tusamitamab ravtansine in Part A (doublet cohort), Part B (triplet cohort) or Part C (quadruplet cohort).
Posted
Count of Participants
Participants
Cycle 1 Day 1 up to Cycle 1 Day 21 (cycle duration=3 weeks)
ID
Title
Description
OG000
Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab
In Part A (doublet cohort), participants received tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
OG001
Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab
In Part A (doublet cohort), participants received tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
In Part B (triplet cohort), participants received tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
In Part B (triplet cohort), participants received tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
ORR was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) as best overall response (BOR) per response evaluation criteria in solid tumors (RECIST) version (v) 1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
All-treated population included all participants assigned to study treatment and who actually received at least 1 dose of study treatment. Data is reported for Part A (doublet cohort) at both tusamitamab ravtansine doses.
Posted
Number
95% Confidence Interval
percentage of participants
Tumor assessments performed at baseline, then every 6 weeks for first 24 weeks, and every 9 weeks thereafter, approximately 158.4 weeks
ID
Title
Description
OG000
Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab
In Part A (doublet cohort), participants received tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
OG001
Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab
Primary
Quadruplet Cohort: Objective Response Rate
ORR was defined as the percentage of participants with a confirmed CR or PR as per RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
All-treated population included all participants assigned to study treatment and who actually received at least 1 dose of study treatment. Data is reported for Part C (quadruplet cohort) at both tusamitamab ravtansine doses.
Posted
Number
95% Confidence Interval
percentage of participants
Tumor assessments performed at baseline, then every 6 weeks for first 24 weeks, and every 9 weeks thereafter, approximately 139.9 weeks
In Part C (quadruplet cohort), participants received tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m^2, and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
OG001
Secondary
All Cohorts: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. A serious AE was defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity or was a congenital anomaly/birth defect. A TEAE was defined as an AE that developed, worsened or became serious during the treatment-emergent period.
All-treated population included all participants assigned to study treatment and who actually received at least 1 dose of study treatment. Data is reported for Part A (doublet cohort), Part B (triplet cohort) and Part C (quadruplet cohort) at both tusamitamab ravtansine doses.
Posted
Count of Participants
Participants
From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet)
ID
Title
Description
OG000
Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab
In Part A (doublet cohort), participants received tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
Secondary
Doublet and Quadruplet Cohorts: Progression-free Survival (PFS)
PFS was defined as the time from the first study treatment administration to the date of the first documented progressive disease (PD) or death due to any cause, whichever came first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of 1 or more new lesions was also considered progression.
All-treated population included all participants assigned to study treatment and who actually received at least 1 dose of study treatment. Data is reported for Part A (doublet cohort) and Part C (quadruplet cohort) at both tusamitamab ravtansine doses.
Posted
Median
95% Confidence Interval
months
Tumor assessments performed at baseline, then every 6 weeks for first 24 weeks, and every 9 weeks thereafter, approximately 158.4 weeks (doublet) and 139.9 weeks (quadruplet)
ID
Title
Description
OG000
Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab
In Part A (doublet cohort), participants received tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
OG001
Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab
Secondary
All Cohorts: Disease Control Rate (DCR)
DCR was defined as percentage of participants with a confirmed CR, confirmed PR or stable disease (SD) as BOR per RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage from the baseline study to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of 1 or more new lesions was also considered progression.
All-treated population included all participants assigned to study treatment and who actually received at least 1 dose of study treatment. Data is reported for Part A (doublet cohort), Part B (triplet cohort) and Part C (quadruplet cohort) at both tusamitamab ravtansine doses.
Posted
Number
95% Confidence Interval
percentage of participants
Tumor assessments performed at baseline, then every 6 weeks for first 24 weeks, and every 9 weeks thereafter, approximately 158.4 weeks (doublet), 113 weeks (triplet), and 139.9 weeks (quadruplet)
ID
Title
Description
OG000
Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab
In Part A (doublet cohort), participants received tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
Secondary
All Cohorts: Duration of Response (DOR)
DOR was defined as the time from first documented evidence of CR or PR until PD determined per RECIST v1.1 or death from any cause, whichever occurred first. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of 1 or more new lesions was also considered progression.
All-treated population included all participants assigned to study treatment and who actually received at least 1 dose of study treatment. Only participants with confirmed CR or PR as BOR were included in the analysis. Data is reported for Part A (doublet cohort), Part B (triplet cohort) and Part C (quadruplet cohort) at both tusamitamab ravtansine doses.
Posted
Median
95% Confidence Interval
months
Tumor assessments performed at baseline, then every 6 weeks for first 24 weeks, and every 9 weeks thereafter, approximately 158.4 weeks (doublet), 113 weeks (triplet), and 139.9 weeks (quadruplet)
ID
Title
Description
OG000
Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab
In Part A (doublet cohort), participants received tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
Secondary
Triplet Cohort: Objective Response Rate
ORR was defined as the percentage of participants with a confirmed CR or PR as per RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
All-treated population included all participants assigned to study treatment and who actually received at least 1 dose of study treatment. Data is reported for Part B (triplet cohort) at both tusamitamab ravtansine doses.
Posted
Number
95% Confidence Interval
percentage of participants
Tumor assessments performed at baseline, then every 6 weeks for first 24 weeks, and every 9 weeks thereafter, approximately 113 weeks
In Part B (triplet cohort), participants received tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
All Cohorts: Trough Concentration (Ctrough) of Tusamitamab Ravtansine
Blood samples were collected for the measurement of tusamitamab ravtansine concentrations.
PK population included all participants from the all-treated population with at least 1 post-baseline PK concentration with adequate documentation of dosing and sampling dates and times. Only those participants with data collected at the specified timepoint are reported. Data is reported for Part A (doublet cohort), Part B (triplet cohort) and Part C (quadruplet cohort) at both tusamitamab ravtansine doses.
Posted
Mean
Standard Deviation
microgram per milliliter (mcg/mL)
Pre-dose on Day 1 of Cycle 2 (cycle duration=3 weeks)
ID
Title
Description
OG000
Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab
In Part A (doublet cohort), participants received tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
OG001
Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab
In Part A (doublet cohort), participants received tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
Secondary
All Cohorts: Ctrough of Pembrolizumab
Blood samples were collected for the measurement of pembrolizumab concentrations.
PK population included all participants from the all-treated population with at least 1 post-baseline PK concentration with adequate documentation of dosing and sampling dates and times. Only those participants with data collected at the specified timepoint are reported. Data is reported for Part A (doublet cohort), Part B (triplet cohort) and Part C (quadruplet cohort) at both tusamitamab ravtansine doses.
Posted
Mean
Standard Deviation
mcg/mL
Pre-dose on Day 1 of Cycle 2 (cycle duration=3 weeks)
ID
Title
Description
OG000
Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab
In Part A (doublet cohort), participants received tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
OG001
Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab
In Part A (doublet cohort), participants received tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
Secondary
Quadruplet Cohort: Plasma Concentration of Pemetrexed
Blood samples were collected for the measurement of pemetrexed concentrations.
PK population included all participants from the all-treated population with at least 1 post-baseline PK concentration with adequate documentation of dosing and sampling dates and times. Only those participants with data collected at the specified timepoint are reported. Data is reported for Part C (quadruplet cohort) at both tusamitamab ravtansine doses.
Posted
Mean
Standard Deviation
mcg/mL
30 minutes post-dose on Day 1 of Cycle 1 (cycle duration=3 weeks)
In Part C (quadruplet cohort), participants received tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m^2, and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
In Part C (quadruplet cohort), participants received tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m^2, and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
Secondary
Triplet and Quadruplet Cohorts: Total Plasma Concentration Observed at the End of Infusion (Ceoi) of Cisplatin
Blood samples were collected for the measurement of cisplatin concentrations.
PK population included all participants from the all-treated population with at least 1 post-baseline PK concentration with adequate documentation of dosing and sampling dates and times. Only those participants with data collected at the specified timepoint are reported. Data is reported for Part B (triplet cohort) and Part C (quadruplet cohort) at both tusamitamab ravtansine doses.
Posted
Mean
Standard Deviation
mcg/mL
At end of infusion on Day 1 of Cycle 1 (cycle duration=3 weeks)
In Part B (triplet cohort), participants received tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
In Part B (triplet cohort), participants received tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
Secondary
Triplet and Quadruplet Cohorts: Total Plasma Concentration Observed at the End of Infusion of Carboplatin
Blood samples were collected for the measurement of carboplatin concentrations.
PK population included all participants from the all-treated population with at least 1 post-baseline PK concentration with adequate documentation of dosing and sampling dates and times. Only those participants with data collected at the specified timepoint are reported. Data is reported for Part B (triplet cohort) and Part C (quadruplet cohort) at both tusamitamab ravtansine doses.
Posted
Mean
Standard Deviation
mcg/mL
At end of infusion on Day 1 of Cycle 1 (cycle duration=3 weeks)
In Part B (triplet cohort), participants received tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
In Part B (triplet cohort), participants received tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
Secondary
All Cohorts: Number of Participants With Treatment-emergent Anti-Therapeutic Antibodies (ATAs) Against Tusamitamab Ravtansine
Blood samples were collected to assess the presence of treatment-emergent ATA against tusamitamab ravtansine. ATA incidence was defined as the number of participants found to have treatment-emergent ATA response during the study.
ATA population included all participants from the all-treated population with at least 1 post-baseline ATA result (negative, positive, or inconclusive). Data is reported for Part A (doublet cohort), Part B (triplet cohort) and Part C (quadruplet cohort) at both tusamitamab ravtansine doses.
Posted
Count of Participants
Participants
From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet)
ID
Title
Description
OG000
Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab
In Part A (doublet cohort), participants received tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
OG001
Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab
In Part A (doublet cohort), participants received tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
Time Frame
From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks.
Description
Analysis was performed on all-treated population.
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
Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab
In Part A (doublet cohort), participants received tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
5
23
9
23
22
23
EG001
Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab
In Part A (doublet cohort), participants received tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
In Part B (triplet cohort), participants received tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
In Part B (triplet cohort), participants received tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
In Part C (quadruplet cohort), participants received tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m^2, and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
In Part C (quadruplet cohort), participants received tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m^2, and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
0
3
2
3
3
3
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pneumonia
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0002 events2 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected3 at risk
Pneumonia Aspiration
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Septic Shock
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Vascular Device Infection
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Metastases To Meninges
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Myocarditis
Cardiac disorders
MedDra 27.1
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDra 27.1
Systematic Assessment
EG0002 events2 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Respiratory Failure
Respiratory, thoracic and mediastinal disorders
MedDra 27.1
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Colitis
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Colitis Ulcerative
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Oesophageal Fistula
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Pneumoperitoneum
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Cholestasis
Hepatobiliary disorders
MedDra 27.1
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Hepatic Cytolysis
Hepatobiliary disorders
MedDra 27.1
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Immune-Mediated Hepatitis
Hepatobiliary disorders
MedDra 27.1
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Bone Pain
Musculoskeletal and connective tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Asthenia
General disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Disease Progression
General disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
General Physical Health Deterioration
General disorders
MedDra 27.1
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Non-Cardiac Chest Pain
General disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Pyrexia
General disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected6 at risk
EG003
Sudden Death
General disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Femoral Neck Fracture
Injury, poisoning and procedural complications
MedDra 27.1
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Toxicity To Various Agents
Injury, poisoning and procedural complications
MedDra 27.1
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nasopharyngitis
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected1 at risk
EG0041 events1 affected22 at risk
EG0050 events0 affected3 at risk
Purulence
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected6 at risk
EG003
Respiratory Tract Infection
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0023 events1 affected6 at risk
EG003
Respiratory Tract Infection Viral
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected6 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected6 at risk
EG003
Viral Infection
Infections and infestations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDra 27.1
Systematic Assessment
EG0002 events2 affected23 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected6 at risk
EG003
Anaemia Megaloblastic
Blood and lymphatic system disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDra 27.1
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDra 27.1
Systematic Assessment
EG0002 events1 affected23 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected6 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0022 events2 affected6 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDra 27.1
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Immune-Mediated Hypothyroidism
Endocrine disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected6 at risk
EG003
Decreased Appetite
Metabolism and nutrition disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0023 events2 affected6 at risk
EG003
Anxiety
Psychiatric disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected6 at risk
EG003
Depressed Mood
Psychiatric disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0022 events1 affected6 at risk
EG003
Insomnia
Psychiatric disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected6 at risk
EG003
Dysaesthesia
Nervous system disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected6 at risk
EG003
Headache
Nervous system disorders
MedDra 27.1
Systematic Assessment
EG0003 events2 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Monoparesis
Nervous system disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Neuropathy Peripheral
Nervous system disorders
MedDra 27.1
Systematic Assessment
EG0007 events6 affected23 at risk
EG0010 events0 affected2 at risk
EG0022 events1 affected6 at risk
EG003
Paraesthesia
Nervous system disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected6 at risk
EG003
Peripheral Sensory Neuropathy
Nervous system disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected6 at risk
EG003
Polyneuropathy
Nervous system disorders
MedDra 27.1
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected6 at risk
EG003
Cataract
Eye disorders
MedDra 27.1
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected6 at risk
EG003
Conjunctivitis Allergic
Eye disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Dry Eye
Eye disorders
MedDra 27.1
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected2 at risk
EG0023 events2 affected6 at risk
EG003
Keratitis
Eye disorders
MedDra 27.1
Systematic Assessment
EG00018 events10 affected23 at risk
EG0012 events1 affected2 at risk
EG0021 events1 affected6 at risk
EG003
Keratopathy
Eye disorders
MedDra 27.1
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Lacrimation Increased
Eye disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Punctate Keratitis
Eye disorders
MedDra 27.1
Systematic Assessment
EG0002 events2 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Vision Blurred
Eye disorders
MedDra 27.1
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected6 at risk
EG003
Visual Acuity Reduced
Eye disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0012 events1 affected2 at risk
EG0022 events2 affected6 at risk
EG003
Visual Impairment
Eye disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected6 at risk
EG003
Hyperaemia
Vascular disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Hypertension
Vascular disorders
MedDra 27.1
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected2 at risk
EG0022 events2 affected6 at risk
EG003
Hypertensive Crisis
Vascular disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected6 at risk
EG003
Hypotension
Vascular disorders
MedDra 27.1
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDra 27.1
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Dry Throat
Respiratory, thoracic and mediastinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDra 27.1
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected6 at risk
EG003
Dyspnoea Exertional
Respiratory, thoracic and mediastinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected6 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected6 at risk
EG003
Interstitial Lung Disease
Respiratory, thoracic and mediastinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Malignant Pleural Effusion
Respiratory, thoracic and mediastinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Nasal Congestion
Respiratory, thoracic and mediastinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Nasal Dryness
Respiratory, thoracic and mediastinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDra 27.1
Systematic Assessment
EG0002 events2 affected23 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected6 at risk
EG003
Productive Cough
Respiratory, thoracic and mediastinal disorders
MedDra 27.1
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected6 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0022 events2 affected6 at risk
EG003
Sputum Discoloured
Respiratory, thoracic and mediastinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected6 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Constipation
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0002 events2 affected23 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0004 events4 affected23 at risk
EG0010 events0 affected2 at risk
EG0024 events2 affected6 at risk
EG003
Dry Mouth
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected6 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected6 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected6 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Gastrooesophageal Reflux Disease
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0001 events1 affected23 at risk
EG0011 events1 affected2 at risk
EG0021 events1 affected6 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0022 events2 affected6 at risk
EG003
Tongue Blistering
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Dry Skin
Skin and subcutaneous tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Palmar-Plantar Erythrodysaesthesia Syndrome
Skin and subcutaneous tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDra 27.1
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDra 27.1
Systematic Assessment
EG0002 events2 affected23 at risk
EG0011 events1 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Skin Hyperpigmentation
Skin and subcutaneous tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected6 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDra 27.1
Systematic Assessment
EG0004 events4 affected23 at risk
EG0011 events1 affected2 at risk
EG0021 events1 affected6 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDra 27.1
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected2 at risk
EG0022 events2 affected6 at risk
EG003
Musculoskeletal Chest Pain
Musculoskeletal and connective tissue disorders
MedDra 27.1
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Musculoskeletal Discomfort
Musculoskeletal and connective tissue disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected6 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDra 27.1
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected6 at risk
EG003
Nephritis
Renal and urinary disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected6 at risk
EG003
Renal Failure
Renal and urinary disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Vulvovaginal Pruritus
Reproductive system and breast disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Asthenia
General disorders
MedDra 27.1
Systematic Assessment
EG0008 events8 affected23 at risk
EG0010 events0 affected2 at risk
EG0028 events4 affected6 at risk
EG003
Chills
General disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Device Related Thrombosis
General disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected6 at risk
EG003
Fatigue
General disorders
MedDra 27.1
Systematic Assessment
EG0002 events2 affected23 at risk
EG0011 events1 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Mucosal Inflammation
General disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected6 at risk
EG003
Non-Cardiac Chest Pain
General disorders
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Oedema Peripheral
General disorders
MedDra 27.1
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Pyrexia
General disorders
MedDra 27.1
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected6 at risk
EG003
Aspartate Aminotransferase Increased
Investigations
MedDra 27.1
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Blood Creatinine Increased
Investigations
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected6 at risk
EG003
Weight Decreased
Investigations
MedDra 27.1
Systematic Assessment
EG0002 events2 affected23 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected6 at risk
EG003
Infusion Related Reaction
Injury, poisoning and procedural complications
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected6 at risk
EG003
Rib Fracture
Injury, poisoning and procedural complications
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected6 at risk
EG003
Device Material Opacification
Product Issues
MedDra 27.1
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected6 at risk
EG003
The study was terminated due to the discontinuation of the overall development of tusamitamab ravtansine by the Sponsor and the enrollment of new participants in this study had been stopped on 21 December 2023.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
In Part C (quadruplet cohort), participants received tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m^2, and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
In Part C (quadruplet cohort), participants received tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m^2, and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
1
OG00421
OG0053
0
OG0040
OG0051
In Part A (doublet cohort), participants received tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
In Part C (quadruplet cohort), participants received tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m^2, and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
Units
Counts
Participants
OG00022
OG0013
Title
Denominators
Categories
Title
Measurements
OG00059.1(36.35 to 79.29)
OG00166.7(9.43 to 99.16)
OG001
Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab
In Part A (doublet cohort), participants received tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
In Part B (triplet cohort), participants received tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
In Part B (triplet cohort), participants received tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
In Part C (quadruplet cohort), participants received tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m^2, and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
In Part C (quadruplet cohort), participants received tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m^2, and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
Units
Counts
Participants
OG00023
OG0012
OG0026
OG0031
OG00422
OG0053
Title
Denominators
Categories
Any TEAE
Title
Measurements
OG00023
OG0012
OG0026
OG0031
OG00422
OG0053
Any TESAE
Title
Measurements
OG0009
OG0010
OG0021
OG003
In Part A (doublet cohort), participants received tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
In Part C (quadruplet cohort), participants received tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m^2, and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
In Part C (quadruplet cohort), participants received tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m^2, and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
Units
Counts
Participants
OG00023
OG0012
OG00222
OG0033
Title
Denominators
Categories
Title
Measurements
OG00028.45(4.107 to NA)NA indicates that the upper limit of 95% confidence interval (CI) was not estimable due to insufficient number of participants with events.
OG001NA(2.891 to NA)NA indicates that the median and upper limit of 95% CI were not estimable due to insufficient number of participants with events.
OG00211.56(5.520 to 15.869)
OG003NA(5.388 to NA)NA indicates that the median and upper limit of 95% CI were not estimable due to insufficient number of participants with events.
OG001
Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab
In Part A (doublet cohort), participants received tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
In Part B (triplet cohort), participants received tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
In Part B (triplet cohort), participants received tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
In Part C (quadruplet cohort), participants received tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m^2, and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
In Part C (quadruplet cohort), participants received tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m^2, and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
Units
Counts
Participants
OG00023
OG0012
OG0026
OG0031
OG00422
OG0053
Title
Denominators
Categories
Title
Measurements
OG00082.6(61.22 to 95.05)
OG001100(15.81 to 100.00)
OG002100(54.07 to 100.00)
OG003100(2.50 to 100.00)
OG00481.8(59.72 to 94.81)
OG005100(29.24 to 100.00)
OG001
Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab
In Part A (doublet cohort), participants received tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
In Part B (triplet cohort), participants received tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
In Part B (triplet cohort), participants received tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
In Part C (quadruplet cohort), participants received tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m^2, and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
In Part C (quadruplet cohort), participants received tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m^2, and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
Units
Counts
Participants
OG00011
OG0010
OG0024
OG0030
OG00413
OG0052
Title
Denominators
Categories
Title
Measurements
OG000NA(7.688 to NA)NA indicates that the median and upper limit of 95% CI were not estimable due to insufficient number of participants with events.
OG00210.45(7.589 to NA)NA indicates that the upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG00412.02(8.345 to 19.220)
OG005NA(4.074 to NA)NA indicates that the median and upper limit of 95% CI were not estimable due to insufficient number of participants with events.
In Part B (triplet cohort), participants received tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
In Part B (triplet cohort), participants received tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
In Part B (triplet cohort), participants received tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
In Part C (quadruplet cohort), participants received tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m^2, and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
In Part C (quadruplet cohort), participants received tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m^2, and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
Units
Counts
Participants
OG00016
OG0012
OG0024
OG0031
OG00417
OG0052
Title
Denominators
Categories
Title
Measurements
OG0008.0± 3.5
OG00111.7± 1.5
OG0027.6± 8.0
OG0030.0± NANA indicates that the standard deviation was not estimable for only 1 participant.
In Part B (triplet cohort), participants received tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
In Part B (triplet cohort), participants received tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
In Part C (quadruplet cohort), participants received tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m^2, and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
In Part C (quadruplet cohort), participants received tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m^2, and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
Units
Counts
Participants
OG0003
OG0012
OG0024
OG0031
OG00417
OG0052
Title
Denominators
Categories
Title
Measurements
OG00014.0± 2.2
OG00116.9± 4.8
OG00213.4± 5.7
OG00314.1± NANA indicates that the standard deviation was not estimable for only 1 participant.
In Part C (quadruplet cohort), participants received tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m^2, and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
In Part C (quadruplet cohort), participants received tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m^2, and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
Units
Counts
Participants
OG0001
OG0010
OG0028
OG0030
Title
Denominators
Categories
Title
Measurements
OG0003.3± NANA indicates that the standard deviation was not estimable for only 1 participant.
In Part C (quadruplet cohort), participants received tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m^2, and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
In Part C (quadruplet cohort), participants received tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m^2, and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
Units
Counts
Participants
OG0004
OG0011
OG00210
OG0032
Title
Denominators
Categories
Title
Measurements
OG00033.4± 5.0
OG00120.8± NANA indicates that the standard deviation was not estimable for only 1 participant.
In Part B (triplet cohort), participants received tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
In Part B (triplet cohort), participants received tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
In Part C (quadruplet cohort), participants received tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m^2, and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
In Part C (quadruplet cohort), participants received tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m^2, and either cisplatin 75 mg/m^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.