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 now · Phase 3

Conditions studied: Non-small Cell Lung Cancer

In brief

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%

Key facts

Study ID

NCT06561386

Run by

Bristol-Myers Squibb

People needed

1000

Starts

2024-10-07

Expected to finish

2032-08-04

Last updated by the study team

2026-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Cincinnati Medical Center — Cincinnati, Ohio, United States (enrolling)
• Hospital Británico de Buenos Aires — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina (enrolling)
• Veterans Affairs New York Harbor Healthcare System — New York, New York, United States (enrolling)
• East Carolina University — Greenville, North Carolina, United States (enrolling)
• Texas Oncology - West Texas — Abilene, Texas, United States (enrolling)
• The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center — Tyler, Texas, United States (enrolling)
• University of California Davis (UC Davis) Comprehensive Cancer Center — Sacramento, California, United States (enrolling)
• Southern Arizona VA Health Care System — Tucson, Arizona, United States (enrolling)
• University of Rochester Medical Center — Rochester, New York, United States (enrolling)
• SUNY Upstate Medical University — Syracuse, New York, United States (enrolling)
• Lancaster General Hospital - Ann B Barshinger Cancer Institute — Lancaster, Pennsylvania, United States (enrolling)
• Florida Cancer Specialists - East — West Palm Beach, Florida, United States (enrolling)
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Affiliated Oncologists, LLC — Chicago Ridge, Illinois, United States (enrolling)
• Cancer Center of Kansas — Wichita, Kansas, United States (enrolling)
• Saint Elizabeth Medical Center Edgewood — Edgewood, Kentucky, United States (enrolling)
• Baptist Health Lexington — Lexington, Kentucky, United States (enrolling)
• University of Miami Hospital and Clinics, Sylvester Cancer Center — Miami, Florida, United States (enrolling)
• Memorial Hospital West — Pembroke Pines, Florida, United States (enrolling)
• San Francisco Oncology Associates — San Francisco, California, United States (enrolling)
• Hattiesburg Clinic Hematology/Oncology — Hattiesburg, Mississippi, United States (enrolling)
• Florida Cancer Specialists - North — St. Petersburg, Florida, United States (enrolling)
• UCLA Hematology/Oncology - Santa Monica — Santa Monica, California, United States (enrolling)
• Renown Regional Medical Center — Reno, Nevada, United States (enrolling)
• Instituto Alexander Fleming — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina (enrolling)

Full record on ClinicalTrials.gov

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