NCT06561386From ClinicalTrials.govRecruiting

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%

Non-small Cell Lung Cancer

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Bristol-Myers Squibb
Enrolment target: 1,000
Started: 7 October 2024
Main results due: 30 July 2030
Study sites: 327
Registry updated: 23 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

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.

What this study is about

In the sponsor’s own words, from the registry.

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%

Study sites(327)

Local Institution - 0487
Mobile, Alabama, United States
Not yet recruiting
Southern Arizona VA Health Care System
Tucson, Arizona, United States
Recruiting
Local Institution - 0112
Los Angeles, California, United States
Withdrawn
University of California Davis (UC Davis) Comprehensive Cancer Center
Sacramento, California, United States
Recruiting
Local Institution - 0159
San Francisco, California, United States
Completed
UCLA Hematology/Oncology - Santa Monica
Santa Monica, California, United States
Recruiting
Local Institution - 0500
Grand Junction, Colorado, United States
Not yet recruiting
Local Institution - 0472
Westminster, Colorado, United States
Not yet recruiting
Local Institution - 0206
Miami, Florida, United States
Completed
Memorial Hospital West
Pembroke Pines, Florida, United States
Recruiting
Florida Cancer Specialists - North
St. Petersburg, Florida, United States
Recruiting
Florida Clinical Trials Group.
Tamarac, Florida, United States
Recruiting
Florida Cancer Specialists - East
West Palm Beach, Florida, United States
Recruiting
Local Institution - 0509
Coeur d'Alene, Idaho, United States
Not yet recruiting
Affiliated Oncologists, LLC
Chicago Ridge, Illinois, United States
Recruiting
Cancer Center of Kansas
Wichita, Kansas, United States
Recruiting
Saint Elizabeth Medical Center Edgewood
Edgewood, Kentucky, United States
Recruiting
Baptist Health Lexington
Lexington, Kentucky, United States
Recruiting
Local Institution - 0502
Paducah, Kentucky, United States
Not yet recruiting
Local Institution - 0505
Annapolis, Maryland, United States
Not yet recruiting
Profound Research LLC - MHP MedOnc Royal Oak - Oakland Medical Group Location
Royal Oak, Michigan, United States
Recruiting
Hattiesburg Clinic Hematology/Oncology
Hattiesburg, Mississippi, United States
Recruiting
Local Institution - 0498
Kansas City, Missouri, United States
Not yet recruiting
Local Institution - 0308
Bozeman, Montana, United States
Completed
Renown Regional Medical Center
Reno, Nevada, United States
Recruiting
Local Institution - 0507
Morristown, New Jersey, United States
Not yet recruiting
Local Institution - 0346
Paterson, New Jersey, United States
Completed
Local Institution - 0381
Albuquerque, New Mexico, United States
Completed
Local Institution - 0356
Hawthorne, New York, United States
Completed
Veterans Affairs New York Harbor Healthcare System
New York, New York, United States
Recruiting
Local Institution - 0380
Northport, New York, United States
Withdrawn
University of Rochester Medical Center
Rochester, New York, United States
Recruiting
Local Institution - 0511
Schenectady, New York, United States
Not yet recruiting
SUNY Upstate Medical University
Syracuse, New York, United States
Recruiting
Local Institution - 0357
The Bronx, New York, United States
Withdrawn
Local Institution - 0352
Asheville, North Carolina, United States
Completed
East Carolina University
Greenville, North Carolina, United States
Recruiting
Local Institution - 0369
Canton, Ohio, United States
Withdrawn
Local Institution - 0486
Centerville, Ohio, United States
Not yet recruiting
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Recruiting
Local Institution - 0199
Cleveland, Ohio, United States
Completed
Local Institution - 0519
Elyria, Ohio, United States
Not yet recruiting
Local Institution - 0366
Massillon, Ohio, United States
Withdrawn
Local Institution - 0512
Zanesville, Ohio, United States
Not yet recruiting
Lancaster General Hospital - Ann B Barshinger Cancer Institute
Lancaster, Pennsylvania, United States
Recruiting
Local Institution - 0504
Philadelphia, Pennsylvania, United States
Not yet recruiting
Texas Oncology - West Texas
Abilene, Texas, United States
Recruiting
Local Institution - 0305
Harlingen, Texas, United States
Withdrawn
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Recruiting
Local Institution - 0517
Houston, Texas, United States
Not yet recruiting
The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center
Tyler, Texas, United States
Recruiting
Local Institution - 0302
Salt Lake City, Utah, United States
Not yet recruiting
Local Institution - 0515
Edmonds, Washington, United States
Not yet recruiting
Local Institution - 0516
Issaquah, Washington, United States
Withdrawn
Local Institution - 0499
Lacey, Washington, United States
Not yet recruiting
Local Institution - 0508
Seattle, Washington, United States
Not yet recruiting
Hospital Británico de Buenos Aires
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Recruiting
Instituto Alexander Fleming
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Recruiting
Hospital Italiano de Buenos Aires
ABB, Buenos Aires F.D., Argentina
Recruiting
Instituto Médico Río Cuarto
Río Cuarto, Córdoba Province, Argentina
Recruiting

Showing 60 of 327 sites — filter to narrow it down. 233 of the 327 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06561386. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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