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RecruitingPhase 3NCT06561386
Official study title

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%

Study summary

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%

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedNivolumab and Relatlimab

Plus 4 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · PD-L1 · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 23, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 3

Interventional

Where is it offered?329 U.S. locations

Locations may change over time.

Who runs it?Bristol-Myers Squibb

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Bristol-Myers Squibb
Interventions being studied
Drug: Nivolumab; Drug: Relatlimab; Drug: Pembrolizumab; Drug: Carboplatin; Drug: Pemetrexed; Drug: Cisplatin
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Metastatic or stage IV→Recurrent or relapsed→
Biomarkers
PD-L1→
Treatment approach
Immunotherapy→Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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/

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Local Institution - 0487Mobile, Alabama
  • Southern Arizona VA Health Care SystemTucson, Arizona
  • Local Institution - 0112Los Angeles, California
  • University of California Davis (UC Davis) Comprehensive Cancer CenterSacramento, California
  • Local Institution - 0159San Francisco, California
  • UCLA Hematology/Oncology - Santa MonicaSanta Monica, California
  • Local Institution - 0500Grand Junction, Colorado
  • Local Institution - 0472Westminster, Colorado
  • Local Institution - 0206Miami, Florida
  • Local Institution - 0162Pembroke Pines, Florida
  • Florida Cancer Specialists - NorthSt. Petersburg, Florida
  • Florida Clinical Trials Group.Tamarac, Florida

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 23, 2026. Always confirm current availability with the study team.

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