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Phase 3Recruiting

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%

Sponsored by Bristol-Myers Squibb

About this study

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%

Where this study is enrolling (22)

  • Southern Arizona VA Health Care System

    Tucson, Arizona

    Call 520-792-1450

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  • UCLA Hematology/Oncology - Santa Monica

    Santa Monica, California

    Call 310-926-5333

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  • University of California Davis (UC Davis) Comprehensive Cancer Center

    Sacramento, California

    Call 718-555-1212

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  • Florida Cancer Specialists - East

    West Palm Beach, Florida

    Call 561-366-4100

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  • Florida Cancer Specialists - North

    St. Petersburg, Florida

    Call 727-842-8411

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Show all 22 locations

  • Florida Clinical Trials Group.

    Tamarac, Florida

    Call 561-447-0614

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  • Memorial Hospital West

    Pembroke Pines, Florida

    Call 000-000-0000

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  • Affiliated Oncologists, LLC

    Chicago Ridge, Illinois

    Call 111111

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  • Cancer Center of Kansas

    Wichita, Kansas

    Call 316-262-4467

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  • Saint Elizabeth Medical Center Edgewood

    Edgewood, Kentucky

    Call 859-301-4000

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  • Baptist Health Lexington

    Lexington, Kentucky

    Call 859-260-6100

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  • Profound Research LLC - MHP MedOnc Royal Oak - Oakland Medical Group Location

    Royal Oak, Michigan

    Call 000-000-0000

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  • Hattiesburg Clinic Hematology/Oncology

    Hattiesburg, Mississippi

    Call 601-261-1700

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  • Renown Regional Medical Center

    Reno, Nevada

    Call 775-985-4000

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  • Veterans Affairs New York Harbor Healthcare System

    New York, New York

    Call 212-523-4000

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  • SUNY Upstate Medical University

    Syracuse, New York

    Call 314-691-8862

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  • University of Rochester Medical Center

    Rochester, New York

    Call 315-525-2102

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  • East Carolina University

    Greenville, North Carolina

    Call 252-744-4929

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  • Lancaster General Hospital - Ann B Barshinger Cancer Institute

    Lancaster, Pennsylvania

    Call 717-215-9561

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  • University of Texas MD Anderson Cancer Center

    Houston, Texas

    Call 877-632-6789

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  • Texas Oncology - West Texas

    Abilene, Texas

    Call 000-000-0000

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  • The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center

    Tyler, Texas

    Call 903-595-7093

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Who can participate

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.

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.