Lung Cancer Clinical Trial
A Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)
Summary
The purpose of this study is to assess the safety profile of relatlimab plus nivolumab in combination with platinum doublet chemotherapy (PDCT) and to determine if nivolumab plus relatlimab in combination with PDCT improves overall response rate (ORR) when compared to nivolumab plus PDCT in participants with previously untreated Stage IV or recurrent non-small cell lung cancer (NSCLC).
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed metastatic non-small cell lung cancer (NSCLC) of squamous (SQ) or non-squamous (NSQ) histology with Stage IV A/B (as defined by the 8th International Association for the Study of Lung Cancer Classification) or recurrent disease following multi-modal therapy for locally advanced disease
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of less than or equal to 1 at screening and confirmed prior to randomization
Measurable disease by computed tomography (CT) or magnetic resonance resources (MRI) per response evaluation criteria in solid tumor version 1.1 (RECIST 1.1) criteria
No prior systemic anti-cancer treatment (including epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) inhibitors) given as primary therapy for advanced or metastatic disease
Exclusion Criteria:
Participants with EGFR, ALK, ROS-1, or known B-rapidly accelerated fibrosarcoma proto-oncogene (BRAF V600E) mutations that are sensitive to available targeted therapy
Untreated CNS metastases
Leptomeningeal metastases (carcinomatous meningitis)
Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to randomization (ie, participants with a history of prior malignancy are eligible if treatment was completed at least 2 years before randomization and the participant has no evidence of disease)
Prior treatment with an anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1 (PD-L1), anti-programmed death-ligand 2 (PD-L2), or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Other protocol-defined inclusion/exclusion criteria apply
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There are 122 Locations for this study
Duarte California, 91010, United States
Orange California, 92868, United States
New Haven Connecticut, 06520, United States
Jacksonville Florida, 32204, United States
Port Saint Lucie Florida, 34952, United States
Athens Georgia, 30607, United States
Wichita Kansas, 67214, United States
Lexington Kentucky, 40503, United States
Louisville Kentucky, 40241, United States
Scarborough Maine, 04074, United States
Omaha Nebraska, 68130, United States
Howell New Jersey, 07731, United States
Bronx New York, 10461, United States
Johnson City New York, 13790, United States
Mineola New York, 11501, United States
New York New York, 10016, United States
New York New York, 10021, United States
Durham North Carolina, 27710, United States
Cincinnati Ohio, 45219, United States
Cleveland Ohio, 44109, United States
Lancaster Pennsylvania, 17604, United States
Pittsburgh Pennsylvania, 15212, United States
Providence Rhode Island, 02903, United States
Greenville South Carolina, 29607, United States
Dallas Texas, 75390, United States
Harlingen Texas, 78550, United States
Tyler Texas, 75701, United States
Spokane Washington, 99208, United States
Morgantown West Virginia, 26506, United States
Rio Cuarto Cordoba, 5800, Argentina
Buenos Aires Distrito Federal, C1426, Argentina
Caba Distrito Federal, 1430, Argentina
Capital LA Rioja, 5300, Argentina
Viedma RIO Negro, 8500, Argentina
Rosario Santa Fe, 2000, Argentina
Cordoba , 5006, Argentina
Cordoba , X5004, Argentina
Camperdown New South Wales, 2050, Australia
Gosford New South Wales, 2250, Australia
Tamworth New South Wales, 2340, Australia
South Brisbane Queensland, 4101, Australia
Ballarat Victoria, 3350, Australia
Bendigo Victoria, 3550, Australia
Box Hill Victoria, 3128, Australia
Frankston Victoria, 3199, Australia
Murdoch Western Australia, 6150, Australia
Nedlands Western Australia, 6009, Australia
Graz , 8036, Austria
Vienna , 1090, Austria
Roeselare West-Vlaanderen, 8800, Belgium
Ghent , 9000, Belgium
Ghent , 9000, Belgium
Natal Rio Grande Do Norte, 59062, Brazil
Ijui Rio Grande Do Sul, 98700, Brazil
Porto Alegre RIO Grande DO SUL, 90050, Brazil
Porto Alegre RIO Grande DO SUL, 91350, Brazil
Barretos Sao Paulo, 14784, Brazil
Santo Andre SAO Paulo, 09060, Brazil
Rio de Janeiro , 20231, Brazil
Sao Paulo , 04014, Brazil
Sao Paulo , 08270, Brazil
Santiago Metropolitana, 75007, Chile
Santiago Metropolitana, 75009, Chile
Santiago Metropolitana, 84203, Chile
Rennes Ille-Et-Vilaine, 35000, France
Dijon cedex , 21079, France
Le Mans , 72037, France
Paris , 70005, France
Paris , 75014, France
Paris , 75018, France
Saint-Mande , 94160, France
Berlin , 12351, Germany
Berlin , 13585, Germany
Essen , 45136, Germany
Grosshansdorf , 22927, Germany
Homburg , 66421, Germany
Lowenstein , 74245, Germany
Marburg , 35043, Germany
Paderborn , 33098, Germany
Ravensburg , 88212, Germany
Dublin , D04 Y, Ireland
Dublin , D09V2, Ireland
Rome RA, 00144, Italy
Candiolo , 10060, Italy
Catania , 95125, Italy
Genova Sampierdarena , 16149, Italy
Milano , 20141, Italy
Pesaro , 61122, Italy
Siena , 53100, Italy
Ciudad de Mexico Distrito Federal, 14050, Mexico
Toluca de Lerdo Estado DE Mexico, 50090, Mexico
Monterrey Nuevo LEON, 64710, Mexico
San Pedro Garza Garcia Nuevo LEON, 66220, Mexico
Arnhem , 6815 , Netherlands
Harderwijk , 3844 , Netherlands
Gdynia , 81-51, Poland
Lublin , 20-09, Poland
Lublin , 20-09, Poland
Olsztyn , 10-35, Poland
Warszawa , 02-78, Poland
Cluj Napoca Cluj, 40001, Romania
Craiova Dolj, 20038, Romania
Craiova Jud. DOLJ, 20034, Romania
Timisoara Timis, 30016, Romania
Craiova , 20009, Romania
Arkhangelsk , 16304, Russian Federation
Saint Petersburg , 19737, Russian Federation
Saint-Petersburg , 19702, Russian Federation
Malaga Andalucia, 29011, Spain
Sevilla Andalucia, 41013, Spain
Badalona Barcelona, 08916, Spain
Las Palmas de Gran Canaria Las Palmas, 35016, Spain
A Coruna , 15006, Spain
Barcelona , 08025, Spain
Barcelona , 08035, Spain
Barcelona , 8036, Spain
Madrid , 28041, Spain
Madrid , 28046, Spain
Valencia , 46026, Spain
Basel , 4031, Switzerland
St. Gallen , 9007, Switzerland
Middlesborough Cleveland, TS4 3, United Kingdom
London Greater London, NW1 2, United Kingdom
Manchester Lancashire, M20 4, United Kingdom
Leicester , LE1 5, United Kingdom
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