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RECRUITING
NCT06561386
PHASE3

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%

Sponsor: Bristol-Myers Squibb

View on ClinicalTrials.gov

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%

Official title: 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%

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1000

Start Date

2024-10-07

Completion Date

2032-08-04

Last Updated

2026-10-23

Healthy Volunteers

No

Interventions

DRUG

Nivolumab

Specified dose on specified days

DRUG

Relatlimab

Specified dose on specified days

DRUG

Pembrolizumab

Specified dose on specified days

DRUG

Carboplatin

Specified dose on specified days

DRUG

Pemetrexed

Specified dose on specified days

DRUG

Cisplatin

Specified dose on specified days

Locations (329)

Local Institution - 0487

Mobile, Alabama, United States

Southern Arizona VA Health Care System

Tucson, Arizona, United States

Local Institution - 0112

Los Angeles, California, United States

University of California Davis (UC Davis) Comprehensive Cancer Center

Sacramento, California, United States

Local Institution - 0159

San Francisco, California, United States

UCLA Hematology/Oncology - Santa Monica

Santa Monica, California, United States

Local Institution - 0500

Grand Junction, Colorado, United States

Local Institution - 0472

Westminster, Colorado, United States

Local Institution - 0206

Miami, Florida, United States

Local Institution - 0162

Pembroke Pines, Florida, United States

Florida Cancer Specialists - North

St. Petersburg, Florida, United States

Florida Clinical Trials Group.

Tamarac, Florida, United States

Florida Cancer Specialists - East

West Palm Beach, Florida, United States

Local Institution - 0509

Coeur d'Alene, Idaho, United States

Local Institution - 0376

Chicago Ridge, Illinois, United States

Cancer Center of Kansas

Wichita, Kansas, United States

Saint Elizabeth Medical Center Edgewood

Edgewood, Kentucky, United States

Baptist Health Lexington

Lexington, Kentucky, United States

Local Institution - 0502

Paducah, Kentucky, United States

Local Institution - 0505

Annapolis, Maryland, United States

Profound Research LLC - MHP MedOnc Royal Oak - Oakland Medical Group Location

Royal Oak, Michigan, United States

Local Institution - 0226

Hattiesburg, Mississippi, United States

Local Institution - 0498

Kansas City, Missouri, United States

Local Institution - 0308

Bozeman, Montana, United States

Renown Regional Medical Center

Reno, Nevada, United States

Local Institution - 0507

Morristown, New Jersey, United States

Local Institution - 0346

Paterson, New Jersey, United States

Local Institution - 0523

Summit, New Jersey, United States

Local Institution - 0381

Albuquerque, New Mexico, United States

Local Institution - 0356

Hawthorne, New York, United States

Local Institution - 0392

New York, New York, United States

Local Institution - 0380

Northport, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

Local Institution - 0511

Schenectady, New York, United States

SUNY Upstate Medical University

Syracuse, New York, United States

Local Institution - 0357

The Bronx, New York, United States

Local Institution - 0352

Asheville, North Carolina, United States

East Carolina University

Greenville, North Carolina, United States

Local Institution - 0369

Canton, Ohio, United States

Local Institution - 0486

Centerville, Ohio, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Local Institution - 0199

Cleveland, Ohio, United States

Local Institution - 0519

Elyria, Ohio, United States

Local Institution - 0366

Massillon, Ohio, United States

Local Institution - 0512

Zanesville, Ohio, United States

Lancaster General Hospital - Ann B Barshinger Cancer Institute

Lancaster, Pennsylvania, United States

Local Institution - 0504

Philadelphia, Pennsylvania, United States

Local Institution - 0520

Philadelphia, Pennsylvania, United States

Texas Oncology - West Texas

Abilene, Texas, United States

Local Institution - 0305

Harlingen, Texas, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Local Institution - 0517

Houston, Texas, United States

The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center

Tyler, Texas, United States

Local Institution - 0302

Salt Lake City, Utah, United States

Local Institution - 0515

Edmonds, Washington, United States

Local Institution - 0516

Issaquah, Washington, United States

Local Institution - 0499

Lacey, Washington, United States

Local Institution - 0508

Seattle, Washington, United States

Hospital Británico de Buenos Aires

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Instituto Alexander Fleming

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

ABB, Buenos Aires F.D., Argentina

Instituto Médico Río Cuarto

Río Cuarto, Córdoba Province, Argentina

Local Institution - 0493

Bariloche, Río Negro Province, Argentina

Sanatorio Parque

Rosario, Santa Fe Province, Argentina

Hospital Privado Universitario de Córdoba

Córdoba, Argentina

Instituto Oncológico de Córdoba

Córdoba, Argentina

Hospital Privado de Comunidad

Mar del Plata, Argentina

Gosford Hospital

Gosford, New South Wales, Australia

GenesisCare North Shore

St Leonards, New South Wales, Australia

The Prince Charles Hospital

Brisbane, Queensland, Australia

Gallipoli Medical Research Ltd

Brisbane, Queensland, Australia

Local Institution - 0057

Elizabeth Vale, South Australia, Australia

Box Hill Hospital

Box Hill, Victoria, Australia

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

St. John of God Murdoch Hospital

Murdoch, Western Australia, Australia

Universitätsklinikum Krems

Krems, Lower Austria, Austria

Klinikum Wels-Grieskirchen GmbH

Wels, Upper Austria, Austria

Klinik Floridsdorf

Vienna, Austria

Antwerp University Hospital

Edegem, Antwerpen, Belgium

UZ Brussel

Brussels, Bruxelles-Capitale, Région de, Belgium

Jessa Ziekenhuis

Hasselt, Limburg, Belgium

Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne

Yvoir, Namur, Belgium

AZ Delta vzw

Roeselare, West-Vlaanderen, Belgium

Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman

Liège, Belgium

Pronutrir

Fortaleza, Ceará, Brazil

Cetus Oncologia - Unidade Belo Horizonte

Belo Horizonte, Minas Gerais, Brazil

CTO - Centro de Tratamento Oncológico

Belém, Pará, Brazil

Liga Norte Riograndense Contra o Câncer

Natal, Rio Grande do Norte, Brazil

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Hospital São Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Clínica de Neoplasias Litoral

Itajaí, Santa Catarina, Brazil

Local Institution - 0501

Timbó, Santa Catarina, Brazil

Fundação Pio XII - Hospital de Câncer de Barretos

Barretos, São Paulo, Brazil

NAIC - Instituto do Câncer

Bauru, São Paulo, Brazil

Centro de Oncologia - CEON+ - Unidade São Caetano do Sul

São Caetano do Sul, São Paulo, Brazil

Instituto do Câncer Brasil-unidade Taubaté

Taubaté, São Paulo, Brazil

Instituto Nacional de Câncer - INCA

Rio de Janeiro, Brazil

Icesp - Instituto Do Câncer Do Estado de São Paulo

São Paulo, Brazil

Local Institution - 0496

São Paulo, Brazil

Local Institution - 0494

Montreal, Quebec, Canada

And 229 more locations on ClinicalTrials.gov