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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%

RecruitingPhase 3

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%

Who can join

Ages 18 and older · All sexes

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.

About the study

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%

What is being tested

Sponsor: Bristol-Myers Squibb · Participants: 1,000 · Started: Oct 7, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06561386

Locations in the U.S.

AlabamaLocal Institution - 0487, Mobile (Not yet recruiting)
ArizonaSouthern Arizona VA Health Care System, Tucson
CaliforniaUniversity of California Davis (UC Davis) Comprehensive Cancer Center, Sacramento
UCLA Hematology/Oncology - Santa Monica, Santa Monica
ColoradoLocal Institution - 0500, Grand Junction (Not yet recruiting)
Local Institution - 0472, Westminster (Not yet recruiting)
FloridaMemorial Hospital West, Pembroke Pines
Florida Cancer Specialists - North, St. Petersburg
Florida Clinical Trials Group., Tamarac
Florida Cancer Specialists - East, West Palm Beach
IdahoLocal Institution - 0509, Coeur d'Alene (Not yet recruiting)
IllinoisAffiliated Oncologists, LLC, Chicago Ridge
KansasCancer Center of Kansas, Wichita
KentuckySaint Elizabeth Medical Center Edgewood, Edgewood
Baptist Health Lexington, Lexington
Local Institution - 0502, Paducah (Not yet recruiting)
MarylandLocal Institution - 0505, Annapolis (Not yet recruiting)
MichiganProfound Research LLC - MHP MedOnc Royal Oak - Oakland Medical Group Location, Royal Oak
MississippiHattiesburg Clinic Hematology/Oncology, Hattiesburg
MissouriLocal Institution - 0498, Kansas City (Not yet recruiting)
NevadaRenown Regional Medical Center, Reno
New JerseyLocal Institution - 0507, Morristown (Not yet recruiting)
New YorkVeterans Affairs New York Harbor Healthcare System, New York
University of Rochester Medical Center, Rochester
Local Institution - 0511, Schenectady (Not yet recruiting)
SUNY Upstate Medical University, Syracuse
North CarolinaEast Carolina University, Greenville
OhioLocal Institution - 0486, Centerville (Not yet recruiting)
University of Cincinnati Medical Center, Cincinnati
Local Institution - 0519, Elyria (Not yet recruiting)
Local Institution - 0512, Zanesville (Not yet recruiting)
PennsylvaniaLancaster General Hospital - Ann B Barshinger Cancer Institute, Lancaster
Local Institution - 0504, Philadelphia (Not yet recruiting)
TexasTexas Oncology - West Texas, Abilene
Local Institution - 0517, Houston (Not yet recruiting)
University of Texas MD Anderson Cancer Center, Houston
The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center, Tyler
UtahLocal Institution - 0302, Salt Lake City (Not yet recruiting)
WashingtonLocal Institution - 0515, Edmonds (Not yet recruiting)
Local Institution - 0499, Lacey (Not yet recruiting)
Local Institution - 0508, Seattle (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.