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Study Comparing Nivolumab and Relatlimab Plus Chemotherapy to Pembrolizumab Plus Chemotherapy for Lung Cancer

This study is for people with advanced or recurrent non-small cell lung cancer (NSCLC) that is non-squamous (a specific type of lung cancer) and has a PD-L1 expression of 1% or higher. It's comparing two treatment approaches: one uses Nivolumab and Relatlimab along with chemotherapy (Carboplatin and Pemetrexed), and the other uses Pembrolizumab with the same chemotherapy. The main goal is to see which treatment helps people live longer, specifically for those with PD-L1 between 1% and 49%. You must be at least 18 years old and have not received prior systemic anti-cancer therapy for advanced disease to participate. The study plans to enroll about 1000 participants.

Study design
This study is comparing two different treatment combinations. It plans to enroll 1000 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for overall survival for up to 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06561386

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%

Recruiting
PHASE3Ages 18+InterventionalTreatment
Bristol-Myers Squibb
~1,000 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:NivolumabRelatlimabPembrolizumabCarboplatinPemetrexedCisplatin

At a glance

Recruiting sites
225 of 322 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall survival (OS) in randomized participants with PD-L1 1% to 49%
Measured over Up to 5 years

Conditions

Non-small Cell Lung Cancer

Explore related trials

Lung Non-Small Cell Carcinoma

Where it's being run

322 sites across 195 states
New York7
Ohio6
Italy6
Turkey (Türkiye)6
Florida5
France5
California4
Texas4

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
[email protected]
855-907-3286
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Overall survival (OS) in randomized participants with PD-L1 1% to 49%Up to 5 years