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Clinical Trials in the UK / NCT06561386
Recruiting Phase 3

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%

NCT06561386 · tracked via the Priya Life Science UK tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 3
Started
2024-10-07
Last updated
2026-09-14

Condition(s) studied

Non-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

NivolumabRelatlimabPembrolizumabCarboplatinPemetrexedCisplatin

Nivolumab: Specified dose on specified days

Relatlimab: Specified dose on specified days

Pembrolizumab: Specified dose on specified days

Carboplatin: Specified dose on specified days

Pemetrexed: Specified dose on specified days

Cisplatin: Specified dose on specified days

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%

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (326)

FacilityCityRegionStatus
Local Institution - 0487 Mobile Alabama Not Yet Recruiting
Southern Arizona VA Health Care System Tucson Arizona Recruiting
Local Institution - 0112 Los Angeles California Withdrawn
University of California Davis (UC Davis) Comprehensive Cancer Center Sacramento California Recruiting
Local Institution - 0159 San Francisco California Completed
UCLA Hematology/Oncology - Santa Monica Santa Monica California Recruiting
Local Institution - 0500 Grand Junction Colorado Not Yet Recruiting
Local Institution - 0472 Westminster Colorado Not Yet Recruiting
Local Institution - 0206 Miami Florida Completed
Memorial Hospital West Pembroke Pines Florida Recruiting
Florida Cancer Specialists - North St. Petersburg Florida Recruiting
Florida Clinical Trials Group. Tamarac Florida Recruiting
Florida Cancer Specialists - East West Palm Beach Florida Recruiting
Local Institution - 0509 Coeur d'Alene Idaho Not Yet Recruiting
Affiliated Oncologists, LLC Chicago Ridge Illinois Recruiting
Cancer Center of Kansas Wichita Kansas Recruiting
Saint Elizabeth Medical Center Edgewood Edgewood Kentucky Recruiting
Baptist Health Lexington Lexington Kentucky Recruiting
Local Institution - 0502 Paducah Kentucky Not Yet Recruiting
Local Institution - 0505 Annapolis Maryland Not Yet Recruiting
Profound Research LLC - MHP MedOnc Royal Oak - Oakland Medical Group Location Royal Oak Michigan Recruiting
Hattiesburg Clinic Hematology/Oncology Hattiesburg Mississippi Recruiting
Local Institution - 0498 Kansas City Missouri Not Yet Recruiting
Local Institution - 0308 Bozeman Montana Completed
Renown Regional Medical Center Reno Nevada Recruiting
Local Institution - 0507 Morristown New Jersey Not Yet Recruiting
Local Institution - 0346 Paterson New Jersey Completed
Local Institution - 0381 Albuquerque New Mexico Completed
Local Institution - 0356 Hawthorne New York Completed
Veterans Affairs New York Harbor Healthcare System New York New York Recruiting
Local Institution - 0380 Northport New York Withdrawn
University of Rochester Medical Center Rochester New York Recruiting
Local Institution - 0511 Schenectady New York Not Yet Recruiting
SUNY Upstate Medical University Syracuse New York Recruiting
Local Institution - 0357 The Bronx New York Withdrawn
Local Institution - 0352 Asheville North Carolina Completed
East Carolina University Greenville North Carolina Recruiting
Local Institution - 0369 Canton Ohio Withdrawn
Local Institution - 0486 Centerville Ohio Not Yet Recruiting
University of Cincinnati Medical Center Cincinnati Ohio Recruiting

+ 286 more sites — see the full list on the official registry below.

On this site

📄 Opdivo (nivolumab) drug profile → 📄 Keytruda (pembrolizumab) drug profile →

More Bristol-Myers Squibb trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06561386 on ClinicalTrials.gov ↗ ← All trials in the UK