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RECRUITINGPhase 3INTERVENTIONAL

A Study to Compare the Efficacy of Nivolumab and Relatlimab Plus Chemotherapy vs Pembrolizumab Plus Chemotherapy for Stage IV/Recurrent Non-squamous Non-small Cell Lung Cancer With PD-L1 Expression ≥ 1%

A Phase 3, Randomized, Open-label Study of Nivolumab + Relatlimab Fixed-dose Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy as First-line Treatment for Participants With Non-squamous (NSQ), Stage IV or Recurrent Non-small Cell Lung Cancer and With Tumor Cell PD-L1 Expression ≥ 1%

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The purpose of this study is to compare the efficacy of Nivolumab and Relatlimab in combination with chemotherapy to Pembrolizumab with Chemotherapy in participants with stage IV or recurrent Non-squamous Non-small Cell Lung Cancer with PD-L1 expression ≥ 1%

Who May Be Eligible (Plain English)

Inclusion Criteria - Participants must have diagnosed by tissue sample (biopsy-confirmed) Stage IV or recurrent Non-small Cell Lung Cancer (NSCLC) of non-squamous (NSQ) histology with no prior systemic anti-cancer therapy given as primary therapy for advanced or metastatic disease. - Participants must have measurable PD-L1 ≥ 1% Tumor Cell (TC) score by the investigational PD-L1 immunohistochemistry (IHC) assay VENTANA PD-L1 (SP263) CDx Assay conducted by central laboratory during the screening period prior to randomization. - Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria. - Participants must have an Easter Cooperative Oncology Group (ECOG) performance status of ≤ 1 at screening. - Participants must have a expected to live at least 3 months at the time of randomization. Exclusion Criteria - Participants must not be pregnant and/or breastfeeding. - Participants with epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS-1 mutations that are sensitive to available targeted inhibitor therapy. Participants with unknown EGFR, ALK, or ROS-1 status are excluded. - Participants with known BRAFV600E mutations, that are sensitive to available targeted inhibitor therapy; participants with known activating rearranged during transfection (RET) mutations or neurotrophic tyrosine receptor kinase (NTRK) fusion gene alterations are excluded. Participants with unknown or indeterminate BRAF mutation, activating RET mutations or NTRK fusion gene alterations are eligible. - Participants must not have untreated central nervous system (CNS) metastases. - Participants must not have leptomeningeal metastases (carcinomatous meningitis). - Participants must not have concurrent malignancy requiring treatment. - Participants must not have an active autoimmune conditions (where your immune system attacks your own body). ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria * Participants must have histologically confirmed Stage IV or recurrent Non-small Cell Lung Cancer (NSCLC) of non-squamous (NSQ) histology with no prior systemic anti-cancer therapy given as primary therapy for advanced or metastatic disease. * Participants must have measurable PD-L1 ≥ 1% Tumor Cell (TC) score by the investigational PD-L1 immunohistochemistry (IHC) assay VENTANA PD-L1 (SP263) CDx Assay conducted by central laboratory during the screening period prior to randomization. * Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria. * Participants must have an Easter Cooperative Oncology Group (ECOG) performance status of ≤ 1 at screening. * Participants must have a life expectancy of at least 3 months at the time of randomization. Exclusion Criteria * Participants must not be pregnant and/or breastfeeding. * Participants with epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS-1 mutations that are sensitive to available targeted inhibitor therapy. Participants with unknown EGFR, ALK, or ROS-1 status are excluded. * Participants with known BRAFV600E mutations, that are sensitive to available targeted inhibitor therapy; participants with known activating rearranged during transfection (RET) mutations or neurotrophic tyrosine receptor kinase (NTRK) fusion gene alterations are excluded. Participants with unknown or indeterminate BRAF mutation, activating RET mutations or NTRK fusion gene alterations are eligible. * Participants must not have untreated central nervous system (CNS) metastases. * Participants must not have leptomeningeal metastases (carcinomatous meningitis). * Participants must not have concurrent malignancy requiring treatment. * Participants must not have an active autoimmune disease. * Participants must not have history of interstitial lung disease or pneumonitis that required oral or intravenous (IV) glucocorticoids to assist with management. * Participants must not have a history of myocarditis. * Participants must not have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or other antibody or drug targeting T-cell co-stimulation or checkpoint pathways. * Other protocol-defined Inclusion/Exclusion criteria apply.

Treatments Being Tested

DRUG

Nivolumab

Specified dose on specified days

DRUG

Relatlimab

Specified dose on specified days

DRUG

Pembrolizumab

Specified dose on specified days

DRUG

Carboplatin

Specified dose on specified days

DRUG

Pemetrexed

Specified dose on specified days

DRUG

Cisplatin

Specified dose on specified days

Locations (20)

Southern Arizona VA Health Care System
Tucson, Arizona, United States
Local Institution - 0112
Los Angeles, California, United States
University of California Davis (UC Davis) Comprehensive Cancer Center
Sacramento, California, United States
San Francisco Oncology Associates
San Francisco, California, United States
UCLA Hematology/Oncology - Santa Monica
Santa Monica, California, United States
University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami, Florida, United States
Memorial Hospital West
Pembroke Pines, Florida, United States
Florida Cancer Specialists - North
St. Petersburg, Florida, United States
Florida Cancer Specialists - East
West Palm Beach, Florida, United States
Affiliated Oncologists, LLC
Chicago Ridge, Illinois, United States
Local Institution - 0251
Wichita, Kansas, United States
Saint Elizabeth Medical Center Edgewood
Edgewood, Kentucky, United States
Local Institution - 0130
Lexington, Kentucky, United States
Hattiesburg Clinic Hematology/Oncology
Hattiesburg, Mississippi, United States
Local Institution - 0308
Bozeman, Montana, United States
Renown Regional Medical Center
Reno, Nevada, United States
Local Institution - 0346
Paterson, New Jersey, United States
Local Institution - 0381
Albuquerque, New Mexico, United States
Local Institution - 0356
Hawthorne, New York, United States
Veterans Affairs New York Harbor Healthcare System
New York, New York, United States