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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%
Sponsor: Bristol-Myers Squibb
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
2026-03-31
Healthy Volunteers
No
Conditions
Interventions
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
Locations (282)
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
San Francisco Oncology Associates
San Francisco, California, United States
UCLA Hematology/Oncology - Santa Monica
Santa Monica, California, United States
University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami, Florida, United States
Memorial Hospital West
Pembroke Pines, Florida, United States
Florida Cancer Specialists - North
St. Petersburg, Florida, United States
Florida Cancer Specialists - East
West Palm Beach, Florida, United States
Affiliated Oncologists, LLC
Chicago Ridge, Illinois, United States
Local Institution - 0251
Wichita, Kansas, United States
Saint Elizabeth Medical Center Edgewood
Edgewood, Kentucky, United States
Local Institution - 0130
Lexington, Kentucky, United States
Hattiesburg Clinic Hematology/Oncology
Hattiesburg, Mississippi, United States
Local Institution - 0308
Bozeman, Montana, United States
Renown Regional Medical Center
Reno, Nevada, United States
Local Institution - 0346
Paterson, New Jersey, United States
Local Institution - 0381
Albuquerque, New Mexico, United States
Local Institution - 0356
Hawthorne, New York, United States
Veterans Affairs New York Harbor Healthcare System
New York, New York, United States
Local Institution - 0380
Northport, New York, United States
University of Rochester Medical Center
Rochester, 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
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Local Institution - 0199
Cleveland, Ohio, United States
Local Institution - 0366
Massillon, Ohio, United States
Lancaster General Hospital - Ann B Barshinger Cancer Institute
Lancaster, 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
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
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
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
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 Nacional de Câncer - INCA
Rio de Janeiro, Brazil
Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo, Brazil
Oncocentro Apys
Viña del Mar, Región de Valparaíso, Chile
Orlandi Oncologia
Santiago, Santiago Metropolitan, Chile
Fundacion Arturo Lopez Perez (FALP)
Santiago, Santiago Metropolitan, Chile
Pontificia Universidad Catolica de Chile
Santiago, Santiago Metropolitan, Chile
Bradfordhill
Santiago, Santiago Metropolitan, Chile
Local Institution - 0182
Hefei, Anhui, China
Beijing Cancer hospital
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Chongqing Three Gorges Central Hospital
Wanzhou, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Huizhou Central People's Hospital
Huizhou, Guangdong, China
Liuzhou People's Hospital
Liuchow, Guangxi, China
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
Local Institution - 0237
Zhengzhou, Henan, China
Local Institution - 0235
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
First Huai'an Hospital Affiliated to Nanjing Medical University
Huai'an, Jiangsu, China
The First affiliated hospital of Nanchang University (Xianghu campus)
Nanchang, Jiangxi, China
Liaoning Cancer Hospital
Shenyang, Liaoning, China
Xi'an International Medical Center Hospital
Xi'an, Shaanxi, China
Shandong Cancer Hospital
Jinan, Shandong, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Zhongshan Hospital,Fudan University
Shanghai, Shanghai Municipality, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, China
Sichuan Cancer hospital
Chengdu, Sichuan, China
The Second People's Hospital of Neijiang
Neijiang, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
The first Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province
Linhai, Zhejiang, China
Guangdong Provincial People's Hospital
Guangzhou, China
Local Institution - 0415
Medellín, Antioquia, Colombia
Local Institution - 0443
Bogotá, Bogota D.C., Colombia
Local Institution - 0418
Bogotá, Bogota D.C., Colombia
Local Institution - 0417
Valledupar, Cesar Department, Colombia
Local Institution - 0416
Pereira, Risaralda Department, Colombia
Local Institution - 0442
Cali, Valle del Cauca Department, Colombia
Aarhus Universitetshospital, Skejby
Aarhus, Central Jutland, Denmark
Sygehus Soenderjylland
Sønderborg, Region Syddanmark, Denmark
Rigshospitalet
Copenhagen, Denmark
CHRU de Brest
Brest, Finistère, France
CHU de Toulouse - Hopital Larrey
Toulouse, Haute-Garonne, France
Local Institution - 0092
Montpellier, Hérault, France
Local Institution - 0093
Rennes, Ille-et-Vilaine, France
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
CHU Lille - Institut Coeur Poumon
Lille, Nord, France
Centre Hospitalier intercommunal de Toulon La Seyne sur Mer
Toulon, Provence-Alpes-Côte d'Azur Region, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, Rhône, France
Centre Hospitalier de la Côte Basque
Bayonne, France
Assistance Publique Hôpitaux de Marseille - Hôpital Nord
Marseille, France
Hopitaux Universitaires Paris Centre-Hopital Cochin
Paris, France
Institut Curie
Paris, France
Klinikum Esslingen
Esslingen am Neckar, Baden-Wurttemberg, Germany
Bundeswehrkrankenhaus Ulm
Ulm, Baden-Wurttemberg, Germany
Local Institution - 0287
Kempten (Allgäu), Bavaria, Germany
Klinikum der Ludwig-Maximilians-Universitaet Muenchen
München, Bavaria, Germany
Universitätsklinikum Marburg
Marburg, Hesse, Germany
Praxis Onkologie am Raschplatz
Hanover, Lower Saxony, Germany
Local Institution - 0469
Dortmund, North Rhine-Westphalia, Germany
Evangelisches Krankenhaus Herne - Eickel
Herne, North Rhine-Westphalia, Germany
Universitätsklinikum Münster - Albert Schweitzer Campus
Münster, North Rhine-Westphalia, Germany
Klinikum Chemnitz
Chemnitz, Saxony, Germany
LungenClinic Grosshansdorf
Großhansdorf, Schleswig-Holstein, Germany
Local Institution - 0466
Lübeck, Schleswig-Holstein, Germany
Charité Campus Virchow-Klinikum
Berlin, Germany
Universitätsklinikum Bonn
Bonn, Germany
Universitaetsklinikum Essen
Essen, Germany
Asklepios Klinik Gauting GmbH
Gauting, Germany
Manipal Hospitals
Bengaluru, Karnataka, India
Regional Cancer Centre - Thiruvananthapuram
Thiruvananthapuram, Kerala, India
Mumbai Oncocare Centre Vile Parle
Mumbai, Maharashtra, India
Tata Memorial Hospital
Mumbai, Maharashtra, India
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India
Local Institution - 0448
New Delhi, National Capital Territory of Delhi, India
Rajiv Gandhi Cancer Institute And Research Centre
New Delhi, National Capital Territory of Delhi, India
Yashoda Hospital
Secunderabad, Telangana, India
Narayana Superspecialty Hospital
Howrah, West Bengal, India
St. James's Hospital
Dublin, Ireland
Beacon Hospital
Dublin, Ireland
Tallaght University Hospital
Dublin, Ireland
Local Institution - 0027
Dublin, Ireland
Instituto Tumori Giovanni Paolo II
Bari, Apulia, Italy
Ospedale Santa Maria delle Croci
Ravenna, Emilia-Romagna, Italy
Local Institution - 0045
Monza, Lombardy, Italy
Local Institution - 0465
Milan, Milano, Italy
A.O.R.N. Ospedale dei Colli - Monaldi V.
Naples, Napoli, Italy
Azienda Ospedaliera Di Rilievo Nazionale A. Cardarelli
Naples, Napoli, Italy
Istituto Nazionale Tumori Regina Elena
Rome, Roma, Italy
Casa di Cura Dott. Pederzoli
Peschiera del Garda, Verona, Italy
Local Institution - 0222
Ravenna, Italy
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
University of Occupational and Enviromental Health
Kitakyushu, Fukuoka, Japan
Kurume University Hospital
Kurume, Fukuoka, Japan
Chugoku Central Hospital
Fukuyama-shi, Hiroshima, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, Japan
Kanagawa Cardiovascular and Respiratory Center
Yokohama, Kanagawa, Japan
Kanagawa cancer center
Yokohama, Kanagawa, Japan
Kochi Medical School Hospital
Nankoku, Kochi, Japan
Sendai Kousei Hospital
Sendai, Miyagi, Japan
Nara Medical University Hospital
Kashihara, Nara, Japan
Niigata Cancer Center Hospital
Niigata, Niigata, Japan
Kurashiki Central Hospital
Kurashiki, Okayama-ken, Japan
Kansai Medical University Hospital
Hirakata, Osaka, Japan
Kindai University Hospital
Sakai, Osaka, Japan
Saitama Medical University International Medical Center
Hidaka, Saitama, Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka, Japan
Shizuoka Cancer Center
Nagaizumi-cho,Sunto-gun, Shizuoka, Japan
The Cancer Institute Hospital of JFCR
Koto, Tokyo, Japan
Hyogo Cancer Center
Akashi, Japan
Fukushima Medical University
Fukushima, Japan
Osaka International Cancer Institute
Osaka, Japan
Cancer Treamtent Clinic and Clinical Trials Sa de Cv
Guadalajara, Jalisco, Mexico
Arké SMO S.A. de C.V.
México, Mexico
Hospital H+ Queretaro
Querétaro, Mexico
Centro Potosino de Investigación Médica
San Luis Potosí City, Mexico
Local Institution - 0030
Harderwijk, Gelderland, Netherlands
Atrium-Orbis - Zuyderland Medisch Centrum Heerlen
Heerlen, Limburg, Netherlands
Local Institution - 0196
's-Hertogenbosch, North Brabant, Netherlands
Local Institution - 0195
Zwolle, Overijssel, Netherlands
Leids Universitair Medisch Centrum
Leiden, South Holland, Netherlands
Local Institution - 0315
The Hague, South Holland, Netherlands
Ziekenhuis Rijnstate
Arnhem, Netherlands
Local Institution - 0032
Groningen, Netherlands
Local Institution - 0407
Tauranga, Bay of Plenty, New Zealand
Tauranga Hospital
Tauranga, Bay of Plenty, New Zealand
Auckland City Hospital
Auckland, New Zealand
Local Institution - 0425
Dunedin, New Zealand
Local Institution - 0406
Wellington, New Zealand
Local Institution - 0255
Konin, Greater Poland Voivodeship, Poland
Centrum Medyczne Pratia Poznań
Poznan, Greater Poland Voivodeship, Poland
Med-Polonia Sp. z o.o.
Poznan, Greater Poland Voivodeship, Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Local Institution - 0259
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0257
Koszalin, West Pomeranian Voivodeship, Poland
Szpital Specjalistyczny w Prabutach Spolka z o.o.
Prabuty, Poland
Instytut Centrum Zdrowia Matki Polki
Lodz, Łódź Voivodeship, Poland
Instituto Português de Oncologia de Lisboa Francisco Gentil
Lisbon, Lisbon District, Portugal
Local Institution - 0404
Coimbra, Portugal
Instituto Português de Oncologia do Porto Francisco Gentil, EPE
Porto, Portugal
Local Institution - 0401
Porto, Portugal
SC Memorial Healthcare International SRL
Bucharest, București, Romania
Institutul Oncologic Bucuresti "Prof. Dr. Alexandru Trestioreanu"
Bucharest, București, Romania
SC Radiotherapy Center Cluj SRL
Florești, Cluj, Romania
Centrul de Oncologie "Sfântul Nectarie"
Craiova, Dolj, Romania
Institutul Oncologic Cluj
Cluj-Napoca, Romania
Institutul Regional de Oncologie
Iași, Romania
Spitalul Municipal Schuller Ploiești
Ploieşti, Romania
Local Institution - 0440
Dammam, Eastern Province, Saudi Arabia
Local Institution - 0409
Jeddah, Makkah Al Mukarramah, Saudi Arabia
Local Institution - 0408
Riyadh, Riyadh Region, Saudi Arabia
Local Institution - 0431
Soweto, Gauteng, South Africa
Local Institution - 0429
Johannesburg, GP, South Africa
Life Groenkloof
Pretoria, GP, South Africa
Sandton Oncology Medical Group (Pty) Ltd
Sandton, GP, South Africa
Cape Town Oncology Trials
Cape Town, Western Cape, South Africa
Chungbuk National University Hospital
Cheongju-si, Chungcheongbuk-do [Chungbuk], South Korea
Gachon University Gil Medical Center
Namdong-gu, Incheon-gwangyeoksi [Incheon], South Korea
Chonnam National University Hwasun Hospital
Hwasun, Jeonranamdo, South Korea
National Cancer Center
Goyang-si, Kyǒnggi-do, South Korea
CHA Bundang Medical Center, CHA University
Seongnam-si, Kyǒnggi-do, South Korea
Pusan National University Hospital
Busan, Pusan-Kwangyǒkshi, South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Asan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
CHUAC-Hospital Teresa Herrera
A Coruña, A Coruña [La Coruña], Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalunya [Cataluña], Spain
Local Institution - 0267
L'Hospitalet de Llobregat, Catalunya [Cataluña], Spain
Hospital Son Llàtzer
Palma, Illes Balears [Islas Baleares], Spain
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Comunidad de, Spain
Local Institution - 0411
Valencia, València, Spain
H.R.U Málaga - Hospital General
Málaga, Spain
Hospital Universitario Virgen Del Rocio
Seville, Spain
Local Institution - 0269
Valencia, Spain
Local Institution - 0291
Lausanne, Canton of Vaud, Switzerland
Local Institution - 0341
Bellinzona, Canton Ticino, Switzerland
Local Institution - 0290
Basel, Switzerland
Local Institution - 0398
Münsterlingen, Switzerland
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
Taipei Medical University Shuang Ho Hospital
New Taipei City, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Local Institution - 0361
Adana, Turkey (Türkiye)
Local Institution - 0365
Adana, Turkey (Türkiye)
Local Institution - 0383
Ankara, Turkey (Türkiye)
Local Institution - 0362
Ankara, Turkey (Türkiye)
Local Institution - 0410
Istanbul, Turkey (Türkiye)
Local Institution - 0364
Istanbul, Turkey (Türkiye)
Local Institution - 0441
Exeter, Devon, United Kingdom
Local Institution - 0349
Dundee, Dundee City, United Kingdom
Forth Valley Royal Hospital
Larbert, Falkirk, United Kingdom
Local Institution - 0189
Glasgow, Glasgow City, United Kingdom
Local Institution - 0021
London, Kensington and Chelsea, United Kingdom
Leicester Royal Infirmary
Leicester, Leicestershire, United Kingdom
St Bartholomew's Hospital
London, London, City of, United Kingdom
Local Institution - 0001
London, London, City of, United Kingdom
Sarah Cannon Research Institute UK
London, United Kingdom
Local Institution - 0020
Manchester, United Kingdom
Local Institution - 0024
Metropolitan Borough of Wirral, United Kingdom
Royal Berkshire Hospital
Reading, United Kingdom