Compares two immunotherapy combinations with chemotherapy for advanced lung cancer
Compares nivolumab with relatlimab plus chemotherapy against pembrolizumab plus chemotherapy in adults.
Plain-language title generated from the registry record
Registry 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%
Key facts
- Where
- Abilene, Albuquerque, Annapolis, Asheville, Bozeman, Canton, Centerville, Chicago Ridge, Cincinnati, Cleveland, Coeur d'Alene, Edgewood, Edmonds, Elyria, Grand Junction, Greenville, Harlingen, Hattiesburg, Hawthorne, Houston, Issaquah, Kansas City, Lacey, Lancaster, Lexington, Los Angeles, Massillon, Miami, Mobile, Morristown, New York, Northport, Paducah, Paterson, Pembroke Pines, Philadelphia, Reno, Rochester, Royal Oak, Sacramento, Salt Lake City, San Francisco, Santa Monica, Schenectady, Seattle, St. Petersburg, Summit, Syracuse, Tamarac, The Bronx, Tucson, Tyler, West Palm Beach, Westminster, Wichita, and Zanesville, United StatesSee the 58 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Which best describes your lung cancer?
- Has the cancer spread to other parts of the body, or is it too advanced to be removed by surgery?
- What was the PD-L1 result of your tumour test?
- Has your cancer spread to the lining around the brain or spinal cord?
Source: NCT06561386, who can take part
Where in United States
- Texas Oncology - West TexasAbilene, United StatesTaking people
- AlbuquerqueAlbuquerque, United StatesNo longer taking part
- Velocity Clinical Research, AnnapolisAnnapolis, United StatesTaking people
- AshevilleAsheville, United StatesNo longer taking part
- BozemanBozeman, United StatesNo longer taking part
- CantonCanton, United StatesNo longer taking part
- CentervilleCenterville, United StatesNot yet recruiting
- Chicago RidgeChicago Ridge, United StatesNo longer taking part
- University of Cincinnati Medical CenterCincinnati, United StatesTaking people
- ClevelandCleveland, United StatesNo longer taking part
- Coeur d'AleneCoeur d'Alene, United StatesNot yet recruiting
- Saint Elizabeth Medical Center EdgewoodEdgewood, United StatesTaking people
- EdmondsEdmonds, United StatesNot yet recruiting
- ElyriaElyria, United StatesNo longer taking part
- Grand JunctionGrand Junction, United StatesNot yet recruiting
- East Carolina UniversityGreenville, United StatesTaking people
- HarlingenHarlingen, United StatesNo longer taking part
- HattiesburgHattiesburg, United StatesNo longer taking part
- HawthorneHawthorne, United StatesNo longer taking part
- HoustonHouston, United StatesNot yet recruiting
- University of Texas - MD Anderson Cancer CenterHouston, United StatesTaking people
- IssaquahIssaquah, United StatesNo longer taking part
- Kansas CityKansas City, United StatesNot yet recruiting
- LaceyLacey, United StatesNot yet recruiting
- Lancaster General Hospital - Ann B Barshinger Cancer InstituteLancaster, United StatesTaking people
- Baptist Health LexingtonLexington, United StatesTaking people
- Los AngelesLos Angeles, United StatesNo longer taking part
- MassillonMassillon, United StatesNo longer taking part
- MiamiMiami, United StatesNo longer taking part
- MobileMobile, United StatesNot yet recruiting
- MorristownMorristown, United StatesNot yet recruiting
- Veterans Affairs New York Harbor Healthcare SystemNew York, United StatesTaking people
- NorthportNorthport, United StatesNo longer taking part
- PaducahPaducah, United StatesNot yet recruiting
- PatersonPaterson, United StatesNo longer taking part
- Pembroke PinesPembroke Pines, United StatesNo longer taking part
- PhiladelphiaPhiladelphia, United StatesNot yet recruiting
- PhiladelphiaPhiladelphia, United StatesNot yet recruiting
- Renown Regional Medical CenterReno, United StatesTaking people
- University of Rochester Medical CenterRochester, United StatesTaking people
- Profound Research LLC - MHP MedOnc Royal Oak - Oakland Medical Group LocationRoyal Oak, United StatesTaking people
- University of California Davis (UC Davis) Comprehensive Cancer CenterSacramento, United StatesTaking people
- Salt Lake CitySalt Lake City, United StatesNot yet recruiting
- San FranciscoSan Francisco, United StatesNo longer taking part
- UCLA Hematology-Oncology - Santa MonicaSanta Monica, United StatesTaking people
- SchenectadySchenectady, United StatesNot yet recruiting
- SeattleSeattle, United StatesNot yet recruiting
- Florida Cancer Specialists - NorthSt. Petersburg, United StatesTaking people
- SummitSummit, United StatesNot yet recruiting
- SUNY Upstate Medical UniversitySyracuse, United StatesTaking people
- Florida Clinical Trials GroupTamarac, United StatesTaking people
- The BronxThe Bronx, United StatesNo longer taking part
- Southern Arizona VA Health Care SystemTucson, United StatesTaking people
- The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer CenterTyler, United StatesTaking people
- Florida Cancer Specialists - EastWest Palm Beach, United StatesTaking people
- WestminsterWestminster, United StatesNot yet recruiting
- Cancer Center of KansasWichita, United StatesTaking people
- ZanesvilleZanesville, United StatesNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bristol-Myers Squibb
- Trial code
- NCT06561386EU 2024-513682-40-01
- Record updated
- 9 November 2026
- Original description
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%Read full original descriptionShow less
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%
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%
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 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 concurrent malignancy requiring treatment; Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. Note: Anti-PD-1, anti-PD-L1 or anti-CTLA-4 therapy given in an adjuvant, neoadjuvant or perioperative setting with at least 6 months between the last dose and date of recurrence are allowed; 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 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 must not be pregnant and/or breastfeeding; Participants must not have untreated central nervous system (CNS) metastases; Participants must not have leptomeningeal metastases (carcinomatous meningitis); Other protocol-defined Inclusion/Exclusion criteria apply.