Efficacy Comparison of Dostarlimab Plus Chemotherapy Vers... | NCT04581824

Label	Type	Description	Intervention Names
Participants receiving dostarlimab plus chemotherapy	Experimental	Participants will receive dostarlimab on Day 1 of every 21 Day cycle followed by pemetrexed, and then followed by cisplatin or carboplatin (Cycles 1 to 4 only) as per investigator decision.	Drug: Dostarlimab Drug: Chemotherapy
Participants receiving pembrolizumab plus chemotherapy	Active Comparator	Participants will receive pembrolizumab on Day 1 of every 21 Day cycle followed by pemetrexed, and then followed by cisplatin or carboplatin (Cycles 1 to 4 only) as per investigator decision.	Drug: Pembrolizumab Drug: Chemotherapy

Name	Type	Description	Arm Group Labels	Other Names
Dostarlimab	Drug	Dostarlimab will be administered through a 30 minute infusion at a dose of 500 milligrams (mg) intravenously (IV) every 3 weeks (Q3W) up to a maximum of 35 cycles (each cycle of 21 days).

Measure	Description	Time Frame
Objective Response Rate (ORR)	ORR was defined as the percentage of participants who had a confirmed complete response (CR) or confirmed partial response (PR) as their best overall response (BOR) recorded from the date of randomization until disease progression or initiation of new anti-cancer therapy, whichever is earlier based on blinded independent central review (BICR) evaluation criteria in solid tumors (RECIST) version 1.1 (v1.1). CR was defined as disappearance of all target lesions. Any pathological lymph nodes must be <10 millimeter in the short axis. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters (e.g., percent change from baseline).	Up to approximately 20 months

Measure	Description	Time Frame
Overall Survival (OS)	OS was defined as the time from the date of randomization to the date of death by any cause.	Up to approximately 46 months
Progression-free Survival (PFS)	PFS was defined as the time from the date of randomization to the date of disease progression (PD) or death by any cause, whichever occurs first. PFS was evaluated using Response Evaluation Criteria in Solid Tumors Criteria (RECIST) version 1.1 based on Investigator assessment. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start).

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participant must be greater than equal to (>=) 18 years old, must be able to understand the study procedures, and agrees to participate in the study by providing written informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Participant has histologically- or cytologically-confirmed metastatic non-squamous NSCLC with documented absence of a sensitizing EGFR, ALK, ROS-1, or BRAFV600E mutation or other genomic aberration for which an approved targeted therapy is available. Mixed tumors will be categorized by the predominant cell type; if the tumor has predominantly squamous cell histology or if small cell elements are present, the participant is ineligible.
Participants must have measurable disease, that is (i.e.) presenting with at least 1 measurable lesion per RECIST v1.1 as determined by the local site Investigator/radiology assessment. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions and if there are other target lesions. If there is only 1 target lesion that was previously irradiated, the participant is not eligible.
Participant has documented PD L1 status by the 22C3 pharmDx assay (Agilent/Dako). If no prior PD L1 result is available at the time of Screening, the participant can be tested locally using the stated method, or central PD L1 testing can be completed. Results are needed for stratification and must be available prior to randomization.
Participant has an ECOG performance status score of 0 or 1.
Participant has a life expectancy of at least 3 months.
Participant has adequate organ function.
Participant has recovered to Grade less than equal to (<=)1 from any prior treatment related toxicities at the time of randomization. A participant with Grade 2 alopecia is an exception to this criterion and may qualify for this study.
Contraceptive use by male and female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Male participants are eligible to participate if they agree to the following during the Treatment Period and for at least 150 days after the last dose of study treatment:
Refrain from donating sperm plus, either:
Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent.
Must agree to use contraception/barrier as follows:
Agree to use a male condom (and should also be advised of the benefit for a female partner to use a highly effective method of contraception, as a condom may break or leak) when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant.
Agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person.
A female participant is eligible to participate if she is not pregnant or breastfeeding, and 1 of the following conditions applies:
Is a woman of non childbearing potential (WONCBP),
Is a WOCBP, using a contraceptive method that is highly effective (with a failure rate of <1% per year and, preferably, with low user dependency) during the Treatment Period and for at least 180 days after the last dose of study treatment and agrees not to donate eggs (ova or oocytes) for the purpose of reproduction during this period. The Investigator should evaluate the potential for contraceptive method failure ( for example [e.g.], noncompliance and recently initiated) in relationship to the first dose of study treatment.
A WOCBP must have a negative highly sensitive pregnancy test (urine or serum, as required by local guidelines) within 72 hours before the first dose of study treatment. If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.

Exclusion Criteria:

Participant has received prior systemic therapy for the treatment of metastatic NSCLC. Participants who have received neoadjuvant or adjuvant chemotherapy are eligible if the neoadjuvant/adjuvant therapy was completed at least 12 months prior to the development of metastatic disease.
Participant has received prior therapy with a PD (L)1 or PD L2 inhibitor, a cytotoxic T lymphocyte associated protein 4 (CTLA 4) inhibitor, a T cell immunoglobulin and mucin domain containing 3 (TIM 3) inhibitor, or any other immunotherapy agent (eg, OX40) for the treatment of cancer.
Participant has received radiation to the lung that is >30 Gray (Gy) within 6 months of the first dose of study treatment.
Participant has completed palliative radiotherapy within 7 days of the first dose of study treatment.
Participant is ineligible if any of the following hepatic characteristics are present:
Alanine aminotransferase (ALT) >2.5 times upper limit of normal (ULN) without liver metastases/tumor infiltration.
ALT >5 times ULN with liver metastases/tumor infiltration.
Bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%)
Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, liver metastases, or otherwise stable chronic liver disease per Investigator assessment)
Participant has a corrected QT interval (QTc) >450 milliseconds (msec) (or QTc >480 msec for participants with bundle branch block).
Participant has had major surgery within 3 weeks of the first dose of study treatment or has not adequately recovered from any AEs (Grade <=1) and/or complications from any major surgery. Surgical implantation of a port catheter is not exclusionary.
Participant has an additional malignancy or a history of prior malignancy, with the exception of adequately treated basal or squamous skin cancer, cervical carcinoma in situ, or bladder carcinoma in situ without evidence of disease, or had a malignancy treated with curative intent and with no evidence of disease recurrence for 5 years since the initiation of that therapy.
Participant has known active brain metastases and/or leptomeningeal metastases. Participants who have received prior therapy for their brain metastases and have radiographically stable central nervous system disease may participate, provided they are neurologically stable for at least 2 weeks before study entry and must be off corticosteroids within 3 days prior to the first dose of study treatment. Stable brain metastases by this definition should be established prior to the first dose of study treatment. Participants with known untreated, asymptomatic brain metastases (i.e., no neurological symptoms, no requirements for corticosteroids, no or minimal surrounding edema, and no lesions >1.5 centimeters [cm]) may participate, but will require regular imaging of the brain as a site of disease.
Participant has tested positive for the presence of hepatitis B surface antigen or has a positive hepatitis C antibody test result at Screening, or within 3 months prior to first dose of study treatment. For potent immunosuppressive agents, participants who test positive for the presence of hepatitis B core antibody should also be excluded.
Participant has an active infection requiring systemic therapy within 1 week prior to the anticipated first dose of study treatment.
Participant has known human immunodeficiency virus (HIV) (positive for HIV 1 or HIV 2 antibodies).
Participant has active autoimmune disease that required systemic treatment in the past 2 years, is immunocompromised in the opinion of the Investigator, or is receiving systemic immunosuppressive treatment. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
Participant has received systemic steroid therapy within 3 days prior to the first dose of the study treatment or is receiving any other form of immunosuppressive medication. Replacement therapy is not considered a form of systemic therapy. Use of inhaled corticosteroids, local steroid injection, or steroid eye drops is allowed.
Participant has symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment of these conditions (including therapeutic thoraco or paracentesis) is eligible.
Participant has current interstitial lung disease, current pneumonitis, or a history of pneumonitis that required the use of oral or IV glucocorticoids to assist with management. Lymphangitic spread of the NSCLC is not exclusionary.
Participant has a history or current evidence of any medical condition, therapy, or laboratory abnormality that might confound the study results, interfere with their participation for the full duration of the study treatment, or indicate it is not in the best interest of the participant to participate, in the opinion of the Investigator.
Participant has clinically active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, or peritoneal carcinomatosis.
Participant has preexisting peripheral neuropathy that is Grade >=2 by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 criteria.
Participant has received a live vaccine within 30 days of the first dose of study treatment. Seasonal flu vaccines that do not contain live virus are permitted.
Participant does not meet requirements per local prescribing guidelines for receiving treatment with either pemetrexed and cisplatin or carboplatin.
Participant has sensitivity to any of the study treatments, or components thereof, or a history of drug or other allergy that, in the opinion of the Investigator or GlaxoSmithKline (GSK) Medical Monitor, contraindicates their participation.
Participant is unable to interrupt aspirin or other nonsteroidal antiinflammatory drugs (NSAIDs), other than an aspirin dose <=1.3 gram (g) per day, for a 5 day period (8 day period for long acting agents, such as piroxicam).

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Denver	North Carolina	80128	United States
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
36317409	Background	Austin D, Melhem M, Gandhi Y, Lu S, Visser S. Comparative analysis of PD-1 target engagement of dostarlimab and pembrolizumab in advanced solid tumors using ex vivo IL-2 stimulation data. CPT Pharmacometrics Syst Pharmacol. 2023 Jan;12(1):87-94. doi: 10.1002/psp4.12878. Epub 2022 Nov 16.
37951954	Background

ID	Title	Description
FG000	Dostarlimab + Chemotherapy	Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received dostarlimab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of dostarlimab was administered as a 30-minute intravenous (IV) infusion every three weeks (Q3W). 500 mg/meter^2 (m^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 14, 2023	Jul 18, 2025

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

Secondary

Overall Survival (OS)

OS was defined as the time from the date of randomization to the date of death by any cause.

Intent-to-treat (ITT) population

Posted

Median

95% Confidence Interval

Months

Up to approximately 46 months

ID	Title	Description
OG000	Dostarlimab + Chemotherapy	Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received dostarlimab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of dostarlimab was administered as a 30-minute intravenous (IV) infusion every three weeks (Q3W). 500 mg/meter^2 (m^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
OG001	Pembrolizumab + Chemotherapy	Participants with metastatic NSCLC received pembrolizumab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: pembrolizumab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 200 mg of pembrolizumab was administered as a 30-minute IV infusion Q3W. 500 mg/meter^2 (m^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.

Units	Counts
Participants	OG000121 OG001122

Title

Denominators

Categories

Title	Measurements
	OG00020.2(14.5 to 27.3) OG00115.9(11.6 to 19.3)

Secondary

Progression-free Survival (PFS)

PFS was defined as the time from the date of randomization to the date of disease progression (PD) or death by any cause, whichever occurs first. PFS was evaluated using Response Evaluation Criteria in Solid Tumors Criteria (RECIST) version 1.1 based on Investigator assessment. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start).

Intent-to-treat (ITT) population

Posted

Median

95% Confidence Interval

Months

Up to approximately 46 months

ID	Title	Description
OG000	Dostarlimab + Chemotherapy	Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received dostarlimab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of dostarlimab was administered as a 30-minute intravenous (IV) infusion every three weeks (Q3W). 500 mg/meter^2 (m^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
OG001

Secondary

Number of Participants With Treatment-emergent Adverse Event (TEAEs), TEAEs Leading to Death and TEAEs Leading to Treatment Discontinuation

AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A TEAE is an event that emerges during treatment having been absent pretreatment or worsens relative to the pretreatment state. Number of participants with TEAEs, TEAEs leading to death, and TEAEs leading to treatment discontinuation are presented. AEs were coded using the Medical Dictionary for Regulatory Affairs (MedDRA dictionary).

Safety population included all participants who received at least 1 dose of study treatment.

Posted

Count of Participants

Participants

Up to 46 months

ID	Title	Description
OG000	Dostarlimab + Chemotherapy	Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received dostarlimab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of dostarlimab was administered as a 30-minute intravenous (IV) infusion every three weeks (Q3W). 500 mg/meter^2 (m^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.

Secondary

Number of Participants With Treatment Emergent Immune-related Adverse Event (irAE)

The irAEs are events which are severe or fatal and can occur in participants treated with monoclonal antibodies directed against immune checkpoints, including pembrolizumab and dostarlimab. While irAEs (eg, diarrhea/colitis, pneumonitis, nephritis, hypophysitis, adrenalitis, thyroiditis, severe skin reactions, uveitis, myocarditis, and hepatotoxicity) usually occur during treatment, symptoms can also manifest after discontinuation of treatment. AEs were coded using the MedDRA dictionary.

Safety population

Posted

Count of Participants

Participants

Up to 46 months

ID	Title	Description
OG000	Dostarlimab + Chemotherapy	Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received dostarlimab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of dostarlimab was administered as a 30-minute intravenous (IV) infusion every three weeks (Q3W). 500 mg/meter^2 (m^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
OG001	Pembrolizumab + Chemotherapy

Secondary

Number of Participants With Serious AEs

An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is an important medical event that may jeopardize the participant or may require medical or surgical intervention to prevent one of the above outcomes. SAEs are subset of AEs. AEs were coded using the MedDRA dictionary.

Safety population

Posted

Count of Participants

Participants

Up to approximately 46 months

ID	Title	Description
OG000	Dostarlimab + Chemotherapy	Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received dostarlimab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of dostarlimab was administered as a 30-minute intravenous (IV) infusion every three weeks (Q3W). 500 mg/meter^2 (m^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
OG001	Pembrolizumab + Chemotherapy

Secondary

Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline

Normal ranges were 30 to 110 units per liter (U/L) (Amylase); 4. 5 to 5. 6 milligram/deciliters (mg/dL) (Calcium); 96 to 100 milliequivalents (mEq)/ L (Chloride); 2. 5 to 4.5 mg/dL (Phosphate); 6 to 8.3 grams/L (protein); 6 to 24 millimoles/L (Urea) and 7 to 20 mg/dL (Urea nitrogen). Participants were counted in worst case category that their value changes to low, normal or no change [NC] or high), unless there is NC in their category. Participants whose laboratory value category was unchanged (e.g. High to High) or whose value became normal, were recorded in "To Normal or No Change" category. Participants were counted twice if participant had values that changed To Low and To High, so percentages may not add to 100%.

Safety population. Only those participants with data available at specified categories have been analyzed.

Posted

Count of Participants

Participants

Up to approximately 46 months

ID	Title	Description
OG000	Dostarlimab + Chemotherapy	Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received dostarlimab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of dostarlimab was administered as a 30-minute intravenous (IV) infusion every three weeks (Q3W). 500 mg/meter^2 (m^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.

Secondary

Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline

Normal ranges were 0.01 to 0.3*10^9 cells/L (basophils); 41 to 50 percentage of red blood cells (RBC) in blood (hematocrit); 80-100 femtoliters (fl) (erythrocytes [referred as Ery] mean corpuscular volume (EMCV)); 2 to 8 percentage of WBC (monocytes); and Women: 4.2 to 5.4 million RBC/ microliter (mcL) of blood and Men: 4.7 to 6.1 million RBC/ mcL (erythrocytes). Participants were counted in worst case category that their value changes to low, normal or no change [NC] or high), unless there is NC in their category. Participants whose laboratory value category was unchanged (e.g. High to High) or whose value became normal, were recorded in "To Normal or No Change" category. Participants were counted twice if participant had values that changed To Low and To High, so percentages may not add to 100%.

Safety population. Only those participants with data available at specified categories have been analyzed.

Posted

Count of Participants

Participants

Up to approximately 46 months

ID	Title	Description
OG000	Dostarlimab + Chemotherapy	Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received dostarlimab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of dostarlimab was administered as a 30-minute intravenous (IV) infusion every three weeks (Q3W). 500 mg/meter^2 (m^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.

Secondary

Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline

Urine samples were collected to assess urine Bilirubin, glucose, ketones, Leukocyte Esterase, Nitrite, occult blood and Protein using dipstick method. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as No Change/Decreased, Increase to TRACE, Increase to +, Increase to ++, Increase to +++ and Increase to ++++. Baseline (Day 1) was defined as the most recent, non-missing value prior to or on the first study treatment dose date.

Safety population. Only those participants with data available at specified categories have been analyzed

Posted

Count of Participants

Participants

Up to approximately 46 months

ID	Title	Description
OG000	Dostarlimab + Chemotherapy	Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received dostarlimab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of dostarlimab was administered as a 30-minute intravenous (IV) infusion every three weeks (Q3W). 500 mg/meter^2 (m^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.

Secondary

Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4)

Blood samples were collected for the assessment Free Triiodothyronine (T3) and Free Thyroxine (T4).

Safety population. Only those participants with data available at specified categories have been analyzed

Posted

Mean

Standard Deviation

Picomoles per liter(pmol/L)

Up to approximately 46 months

ID	Title	Description
OG000	Dostarlimab + Chemotherapy	Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received dostarlimab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of dostarlimab was administered as a 30-minute intravenous (IV) infusion every three weeks (Q3W). 500 mg/meter^2 (m^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
OG001	Pembrolizumab + Chemotherapy	Participants with metastatic NSCLC received pembrolizumab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: pembrolizumab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 200 mg of pembrolizumab was administered as a 30-minute IV infusion Q3W. 500 mg/meter^2 (m^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.

Secondary

Change From Baseline in Thyroid Function: Thyrotropin (TSH)

Blood samples were collected for the assessment of Thyroid Function Thyrotropin (TSH).

Safety population. Only those participants with data available at specified categories have been analyzed

Posted

Mean

Standard Deviation

Milli-international Units/ Liter

Up to approximately 46 months

ID	Title	Description
OG000	Dostarlimab + Chemotherapy	Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received dostarlimab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of dostarlimab was administered as a 30-minute intravenous (IV) infusion every three weeks (Q3W). 500 mg/meter^2 (m^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
OG001	Pembrolizumab + Chemotherapy	Participants with metastatic NSCLC received pembrolizumab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: pembrolizumab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 200 mg of pembrolizumab was administered as a 30-minute IV infusion Q3W. 500 mg/meter^2 (m^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.

Secondary

Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4)

Blood samples were collected for the assessment of Triiodothyronine (T3) and Thyroxine (T4).

Safety population. Only those participants with data available at specified categories have been analyzed

Posted

Mean

Standard Deviation

Nanomoles per liter (nmol/L)

Up to approximately 46 months

ID	Title	Description
OG000	Dostarlimab + Chemotherapy	Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received dostarlimab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of dostarlimab was administered as a 30-minute intravenous (IV) infusion every three weeks (Q3W). 500 mg/meter^2 (m^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
OG001	Pembrolizumab + Chemotherapy	Participants with metastatic NSCLC received pembrolizumab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: pembrolizumab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 200 mg of pembrolizumab was administered as a 30-minute IV infusion Q3W. 500 mg/meter^2 (m^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.

Secondary

Number of Participants With Worst-case Grade Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)

DBP and SBP were measured in a semi-supine position after 5 minutes rest. Grades were derived based on numeric criteria as defined in Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Systolic Blood Pressure (SBP): Grade 0 (<120 Millimetre of mercury (mmHg)), Grade 1 (120-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (>=160 mmHg). Diastolic Blood Pressure (DBP): Grade 0 (<80 mmHg), Grade 1 (80-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (>=100 mmHg). An increase is defined as an increase in the CTCAE grade relative to the Baseline grade. Only those participants with grade increase have been presented. Participants with missing Baseline values were assumed to have a Baseline value of G0.

Safety population. Only those participants with data available at specified categories have been analyzed.

Posted

Count of Participants

Participants

Up to approximately 46 months

ID	Title	Description
OG000	Dostarlimab + Chemotherapy	Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received dostarlimab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of dostarlimab was administered as a 30-minute intravenous (IV) infusion every three weeks (Q3W). 500 mg/meter^2 (m^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.

Secondary

Number of Participants With Worst Case Pulse Rate Results Post-Baseline Relative to Baseline Based on Potential Clinical Importance (PCI)

Normal range of Pulse Rate was 60 to 100 beats/min. Participants were counted in worst case category that their value changes to low, to within [w/in] Range or No Change [NC] or high, unless there is NC in their category. Participants whose laboratory value category was unchanged (e.g. High to High) or whose value became normal, were recorded in "To Normal or No Change" category.

Safety population. Only those participants with data available at specified categories have been analyzed.

Posted

Count of Participants

Participants

Up to approximately 46 months

ID	Title	Description
OG000	Dostarlimab + Chemotherapy	Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received dostarlimab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of dostarlimab was administered as a 30-minute intravenous (IV) infusion every three weeks (Q3W). 500 mg/meter^2 (m^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
OG001

Secondary

Number of Participants With Worst-Case Post-Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status

Performance status was assessed using the ECOG scale (Grade 0-5). Grades: 0: Fully active, able to carry on all pre-disease performance without restriction. 1: Restricted in physically strenuous activity but ambulatory, able to carry out work of light nature. 2: Ambulatory, capable of self-care, unable to carry out work activities. Up and about more than 50% waking hours. 3: Capable of limited self-care, confined to bed/chair more than 50% waking hours. 4: Completely disabled. Cannot carry on any self-care. Totally confined to bed/chair. 5: Dead.

Safety population.

Posted

Count of Participants

Participants

Up to approximately 46 months

ID	Title	Description
OG000	Dostarlimab + Chemotherapy	Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received dostarlimab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of dostarlimab was administered as a 30-minute intravenous (IV) infusion every three weeks (Q3W). 500 mg/meter^2 (m^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.

Secondary

Mean Change From Baseline in Electrocardiogram (ECG) Parameters

Participants were in a supine or semi recumbent position (about 30 degrees of elevation) and rested for approximately 2 minutes before ECGs were recorded. Single 12-lead ECG was recorded using an ECG machine. PR, QRS, QT, QTcF, and RR intervals were recorded

Safety population. Only those participants with data available at specified categories have been analyzed

Posted

Mean

Standard Deviation

Millisecond (msec)

Baseline (Day 1), Cycle 1 Day 1, and end of treatment (Up to approximately 46 months)

ID	Title	Description
OG000	Dostarlimab + Chemotherapy	Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received dostarlimab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of dostarlimab was administered as a 30-minute intravenous (IV) infusion every three weeks (Q3W). 500 mg/meter^2 (m^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
OG001	Pembrolizumab + Chemotherapy

Secondary

Mean Change From Baseline in ECG Mean Heart Rate

Safety population. Only those participants with data available at specified categories have been analyzed

Posted

Mean

Standard Deviation

beats/min

Baseline (Day 1), Cycle 1 Day 1, and end of treatment (Up to approximately 46 months)

ID	Title	Description
OG000	Dostarlimab + Chemotherapy	Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received dostarlimab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of dostarlimab was administered as a 30-minute intravenous (IV) infusion every three weeks (Q3W). 500 mg/meter^2 (m^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
OG001	Pembrolizumab + Chemotherapy	Participants with metastatic NSCLC received pembrolizumab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: pembrolizumab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 200 mg of pembrolizumab was administered as a 30-minute IV infusion Q3W. 500 mg/meter^2 (m^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.

Secondary

Number Participant Who Used Concomitant Medications

Number of participants received concomitant medications were summarized.

Safety population

Posted

Count of Participants

Participants

Up to approximately 46 months

ID	Title	Description
OG000	Dostarlimab + Chemotherapy	Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received dostarlimab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of dostarlimab was administered as a 30-minute intravenous (IV) infusion every three weeks (Q3W). 500 mg/meter^2 (m^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
OG001	Pembrolizumab + Chemotherapy	Participants with metastatic NSCLC received pembrolizumab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: pembrolizumab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 200 mg of pembrolizumab was administered as a 30-minute IV infusion Q3W. 500 mg/meter^2 (m^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.

Primary

Objective Response Rate (ORR)

ORR was defined as the percentage of participants who had a confirmed complete response (CR) or confirmed partial response (PR) as their best overall response (BOR) recorded from the date of randomization until disease progression or initiation of new anti-cancer therapy, whichever is earlier based on blinded independent central review (BICR) evaluation criteria in solid tumors (RECIST) version 1.1 (v1.1). CR was defined as disappearance of all target lesions. Any pathological lymph nodes must be <10 millimeter in the short axis. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters (e.g., percent change from baseline).

Intent-to-treat (ITT) population included all participants who were randomized.

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to approximately 20 months

ID	Title	Description
OG000	Dostarlimab + Chemotherapy	Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received dostarlimab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of dostarlimab was administered as a 30-minute intravenous (IV) infusion every three weeks (Q3W). 500 mg/meter^2 (m^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v 27.0	Systematic Assessment	EG00011 events9 affected121 at risk EG0017 events6 affected122 at risk
Autoimmune haemolytic anaemia	Blood and lymphatic system disorders	MedDRA v 27.0	Systematic Assessment	EG0001 events1 affected121 at risk EG0010 events0 affected122 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA v 27.0	Systematic Assessment	EG0004 events4 affected121 at risk EG0014 events4 affected122 at risk
Myelosuppression	Blood and lymphatic system disorders	MedDRA v 27.0	Systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected122 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA v 27.0	Systematic Assessment	EG0000 events0 affected121 at risk EG0013 events3 affected122 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA v 27.0	Systematic Assessment	EG0000 events0 affected121 at risk EG0012 events2 affected122 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA v 27.0	Systematic Assessment	EG0003 events3 affected121 at risk EG0013 events3 affected122 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA v 27.0	Systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected122 at risk
Cardiac arrest	Cardiac disorders	MedDRA v 27.0	Systematic Assessment	EG0000 events0 affected121 at risk EG0012 events2 affected122 at risk
Cardiac failure	Cardiac disorders	MedDRA v 27.0	Systematic Assessment	EG0001 events1 affected121 at risk EG0011 events1 affected122 at risk
Pericardial effusion	Cardiac disorders	MedDRA v 27.0	Systematic Assessment	EG0002 events1 affected121 at risk EG0012 events2 affected122 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA v 27.0	Systematic Assessment	EG0001 events1 affected121 at risk EG0010 events0 affected122 at risk
Colitis	Gastrointestinal disorders	MedDRA v 27.0	Systematic Assessment	EG0002 events1 affected121 at risk EG0012 events2 affected122 at risk
Constipation	Gastrointestinal disorders	MedDRA v 27.0	Systematic Assessment	EG0001 events1 affected121 at risk EG0012 events2 affected122 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA v 27.0	Systematic Assessment	EG0002 events2 affected121 at risk EG0012 events2 affected122 at risk
Dysphagia	Gastrointestinal disorders	MedDRA v 27.0	Systematic Assessment	EG0001 events1 affected121 at risk EG0010 events0 affected122 at risk
Enteritis	Gastrointestinal disorders	MedDRA v 27.0	Systematic Assessment	EG0001 events1 affected121 at risk EG0010 events0 affected122 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA v 27.0	Systematic Assessment	EG0001 events1 affected121 at risk EG0010 events0 affected122 at risk
Nausea	Gastrointestinal disorders	MedDRA v 27.0	Systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected122 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA v 27.0	Systematic Assessment	EG0001 events1 affected121 at risk EG0010 events0 affected122 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA v 27.0	Systematic Assessment	EG0001 events1 affected121 at risk EG0010 events0 affected122 at risk
Vomiting	Gastrointestinal disorders	MedDRA v 27.0	Systematic Assessment	EG0001 events1 affected121 at risk EG0011 events1 affected122 at risk
Asthenia	General disorders	MedDRA v 27.0	Systematic Assessment	EG0003 events3 affected121 at risk EG0011 events1 affected122 at risk
Chest pain	General disorders	MedDRA v 27.0	Systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected122 at risk
Disease progression	General disorders	MedDRA v 27.0	Systematic Assessment	EG0001 events1 affected121 at risk EG0010 events0 affected122 at risk
General physical health deterioration	General disorders	MedDRA v 27.0	Systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected122 at risk
Pain	General disorders	MedDRA v 27.0	Systematic Assessment	EG0002 events2 affected121 at risk EG0010 events0 affected122 at risk
Pyrexia	General disorders	MedDRA v 27.0	Systematic Assessment	EG0001 events1 affected121 at risk EG0014 events4 affected122 at risk
Sudden cardiac death	General disorders	MedDRA v 27.0	Systematic Assessment	EG0001 events1 affected121 at risk EG0010 events0 affected122 at risk
Sudden death	General disorders	MedDRA v 27.0	Systematic Assessment	EG0003 events3 affected121 at risk EG0010 events0 affected122 at risk
Hepatitis	Hepatobiliary disorders	MedDRA v 27.0	Systematic Assessment	EG0001 events1 affected121 at risk EG0010 events0 affected122 at risk
Hypersensitivity	Immune system disorders	MedDRA v 27.0	Systematic Assessment	EG0001 events1 affected121 at risk EG0010 events0 affected122 at risk
COVID-19	Infections and infestations	MedDRA v 27.0	Systematic Assessment	EG0005 events4 affected121 at risk EG0013 events3 affected122 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA v 27.0	Systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected122 at risk
Cellulitis	Infections and infestations	MedDRA v 27.0	Systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected122 at risk
Clostridium difficile infection	Infections and infestations	MedDRA v 27.0	Systematic Assessment	EG0000 events0 affected121 at risk EG0012 events1 affected122 at risk
Gastroenteritis salmonella	Infections and infestations	MedDRA v 27.0	Systematic Assessment	EG0001 events1 affected121 at risk EG0010 events0 affected122 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA v 27.0	Systematic Assessment	EG0002 events1 affected121 at risk EG0011 events1 affected122 at risk
Pneumonia	Infections and infestations	MedDRA v 27.0	Systematic Assessment	EG0004 events4 affected121 at risk EG00115 events15 affected122 at risk
Pulmonary sepsis	Infections and infestations	MedDRA v 27.0	Systematic Assessment	EG0001 events1 affected121 at risk EG0010 events0 affected122 at risk
Respiratory tract infection	Infections and infestations	MedDRA v 27.0	Systematic Assessment	EG0003 events3 affected121 at risk EG0011 events1 affected122 at risk
Sepsis	Infections and infestations	MedDRA v 27.0	Systematic Assessment	EG0002 events2 affected121 at risk EG0012 events2 affected122 at risk
Septic shock	Infections and infestations	MedDRA v 27.0	Systematic Assessment	EG0002 events2 affected121 at risk EG0012 events2 affected122 at risk
Strongyloidiasis	Infections and infestations	MedDRA v 27.0	Systematic Assessment	EG0001 events1 affected121 at risk EG0010 events0 affected122 at risk
Urinary tract infection	Infections and infestations	MedDRA v 27.0	Systematic Assessment	EG0001 events1 affected121 at risk EG0010 events0 affected122 at risk
Urosepsis	Infections and infestations	MedDRA v 27.0	Systematic Assessment	EG0001 events1 affected121 at risk EG0010 events0 affected122 at risk
Viral infection	Infections and infestations	MedDRA v 27.0	Systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected122 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA v 27.0	Systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected122 at risk
Gastroenteritis radiation	Injury, poisoning and procedural complications	MedDRA v 27.0	Systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected122 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA v 27.0	Systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected122 at risk
Wound complication	Injury, poisoning and procedural complications	MedDRA v 27.0	Systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected122 at risk
Alanine aminotransferase increased	Investigations	MedDRA v 27.0	Systematic Assessment	EG0003 events2 affected121 at risk EG0011 events1 affected122 at risk
Aspartate aminotransferase increased	Investigations	MedDRA v 27.0	Systematic Assessment	EG0002 events1 affected121 at risk EG0010 events0 affected122 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA v 27.0	Systematic Assessment	EG0001 events1 affected121 at risk EG0010 events0 affected122 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA v 27.0	Systematic Assessment	EG0001 events1 affected121 at risk EG0010 events0 affected122 at risk
Platelet count decreased	Investigations	MedDRA v 27.0	Systematic Assessment	EG0000 events0 affected121 at risk EG0012 events2 affected122 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA v 27.0	Systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected122 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA v 27.0	Systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected122 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA v 27.0	Systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected122 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA v 27.0	Systematic Assessment	EG0000 events0 affected121 at risk EG0012 events2 affected122 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA v 27.0	Systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected122 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA v 27.0	Systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected122 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA v 27.0	Systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected122 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v 27.0	Systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected122 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v 27.0	Systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected122 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA v 27.0	Systematic Assessment	EG0001 events1 affected121 at risk EG0010 events0 affected122 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA v 27.0	Systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected122 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA v 27.0	Systematic Assessment	EG0001 events1 affected121 at risk EG0010 events0 affected122 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 27.0	Systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected122 at risk
Gastrointestinal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 27.0	Systematic Assessment	EG0001 events1 affected121 at risk EG0010 events0 affected122 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA v 27.0	Systematic Assessment	EG0001 events1 affected121 at risk EG0010 events0 affected122 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA v 27.0	Systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected122 at risk
Dysarthria	Nervous system disorders	MedDRA v 27.0	Systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected122 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA v 27.0	Systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected122 at risk
Immune-mediated encephalitis	Nervous system disorders	MedDRA v 27.0	Systematic Assessment	EG0001 events1 affected121 at risk EG0010 events0 affected122 at risk
Ischaemic stroke	Nervous system disorders	MedDRA v 27.0	Systematic Assessment	EG0001 events1 affected121 at risk EG0010 events0 affected122 at risk
Monoparesis	Nervous system disorders	MedDRA v 27.0	Systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected122 at risk
Seizure	Nervous system disorders	MedDRA v 27.0	Systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected122 at risk
Transient aphasia	Nervous system disorders	MedDRA v 27.0	Systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected122 at risk
Confusional state	Psychiatric disorders	MedDRA v 27.0	Systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected122 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA v 27.0	Systematic Assessment	EG0001 events1 affected121 at risk EG0011 events1 affected122 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA v 27.0	Systematic Assessment	EG0001 events1 affected121 at risk EG0010 events0 affected122 at risk
Pollakiuria	Renal and urinary disorders	MedDRA v 27.0	Systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected122 at risk
Renal failure	Renal and urinary disorders	MedDRA v 27.0	Systematic Assessment	EG0001 events1 affected121 at risk EG0010 events0 affected122 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA v 27.0	Systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected122 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA v 27.0	Systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected122 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA v 27.0	Systematic Assessment	EG0002 events2 affected121 at risk EG0013 events3 affected122 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA v 27.0	Systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected122 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v 27.0	Systematic Assessment	EG0005 events5 affected121 at risk EG0014 events4 affected122 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA v 27.0	Systematic Assessment	EG0000 events0 affected121 at risk EG0013 events3 affected122 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA v 27.0	Systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected122 at risk
Immune-mediated lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA v 27.0	Systematic Assessment	EG0001 events1 affected121 at risk EG0010 events0 affected122 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA v 27.0	Systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected122 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA v 27.0	Systematic Assessment	EG0005 events4 affected121 at risk EG0011 events1 affected122 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA v 27.0	Systematic Assessment	EG0003 events3 affected121 at risk EG0015 events5 affected122 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA v 27.0	Systematic Assessment	EG0002 events2 affected121 at risk EG0012 events2 affected122 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA v 27.0	Systematic Assessment	EG0001 events1 affected121 at risk EG0010 events0 affected122 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA v 27.0	Systematic Assessment	EG0000 events0 affected121 at risk EG0014 events3 affected122 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA v 27.0	Systematic Assessment	EG0001 events1 affected121 at risk EG0010 events0 affected122 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA v 27.0	Systematic Assessment	EG0001 events1 affected121 at risk EG0010 events0 affected122 at risk
Embolism	Vascular disorders	MedDRA v 27.0	Systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected122 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA v 27.0	Systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected122 at risk

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Title	Description
BG000	Dostarlimab + Chemotherapy	Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received dostarlimab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of dostarlimab was administered as a 30-minute intravenous (IV) infusion every three weeks (Q3W). 500 mg/meter^2 (m^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
BG001	Pembrolizumab + Chemotherapy	Participants with metastatic NSCLC received pembrolizumab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: pembrolizumab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 200 mg of pembrolizumab was administered as a 30-minute IV infusion Q3W. 500 mg/meter^2 (m^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Dostarlimab + Chemotherapy	Participants with metastatic non-squamous non-small cell lung cancer (NSCLC) received dostarlimab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: dostarlimab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 500 milligram (mg) of dostarlimab was administered as a 30-minute intravenous (IV) infusion every three weeks (Q3W). 500 mg/meter^2 (m^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.	80	121	51	121	117	121
EG001	Pembrolizumab + Chemotherapy	Participants with metastatic NSCLC received pembrolizumab and chemotherapy on Day 1 of every 21-day cycle beginning with Cycle 1. The order of administration of the investigational treatments was: pembrolizumab first, immediately followed by pemetrexed, followed by cisplatin or carboplatin (Cycles 1 to 4 only). 200 mg of pembrolizumab was administered as a 30-minute IV infusion Q3W. 500 mg/meter^2 (m^2) pemetrexed was administered as a 10-minute IV infusion Q3W. 75 mg/m^2 cisplatin was administered via IV infusion approximately 30 minutes after pemetrexed infusion for Q3W or carboplatin at area under the concentration-time curve (AUC) 5 mg/milliliter/minute Q3W immediately following the pemetrexed infusion.	91	122	61	122	114	122

ID	Term
C000719628	dostarlimab
C582435	pembrolizumab
D004358	Drug Therapy