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).

View Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

420

Study ID:

NCT04623775

Recruitment Status:

Active, not recruiting

Sponsor:

Bristol-Myers Squibb

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There are 122 Locations for this study

See Locations Near You

Local Institution - 0160
Duarte California, 91010, United States
Local Institution - 0081
Orange California, 92868, United States
Local Institution - 0139
New Haven Connecticut, 06520, United States
Local Institution - 0153
Jacksonville Florida, 32204, United States
Local Institution - 0011
Port Saint Lucie Florida, 34952, United States
Local Institution - 0089
Athens Georgia, 30607, United States
Local Institution - 0121
Wichita Kansas, 67214, United States
Local Institution - 0159
Lexington Kentucky, 40503, United States
Local Institution - 0002
Louisville Kentucky, 40241, United States
Local Institution - 0082
Scarborough Maine, 04074, United States
Local Institution - 0129
Omaha Nebraska, 68130, United States
Local Institution - 0152
Howell New Jersey, 07731, United States
Local Institution - 0097
Bronx New York, 10461, United States
Local Institution - 0124
Johnson City New York, 13790, United States
Local Institution - 0162
Mineola New York, 11501, United States
Local Institution - 0128
New York New York, 10016, United States
Local Institution - 0165
New York New York, 10021, United States
Local Institution - 0117
Durham North Carolina, 27710, United States
Local Institution - 0156
Cincinnati Ohio, 45219, United States
Local Institution - 0155
Cleveland Ohio, 44109, United States
Local Institution - 0084
Lancaster Pennsylvania, 17604, United States
Local Institution - 0147
Pittsburgh Pennsylvania, 15212, United States
Local Institution - 0148
Providence Rhode Island, 02903, United States
Local Institution - 0083
Greenville South Carolina, 29607, United States
Local Institution - 0149
Dallas Texas, 75390, United States
Local Institution - 0091
Harlingen Texas, 78550, United States
Local Institution - 0001
Tyler Texas, 75701, United States
Local Institution - 0092
Spokane Washington, 99208, United States
Local Institution - 0157
Morgantown West Virginia, 26506, United States
Local Institution - 0037
Rio Cuarto Cordoba, 5800, Argentina
Local Institution - 0021
Buenos Aires Distrito Federal, C1426, Argentina
Local Institution - 0014
Caba Distrito Federal, 1430, Argentina
Local Institution - 0073
Capital LA Rioja, 5300, Argentina
Local Institution - 0039
Viedma RIO Negro, 8500, Argentina
Local Institution - 0029
Rosario Santa Fe, 2000, Argentina
Local Institution - 0060
Cordoba , 5006, Argentina
Local Institution - 0038
Cordoba , X5004, Argentina
Local Institution - 0055
Camperdown New South Wales, 2050, Australia
Local Institution - 0086
Gosford New South Wales, 2250, Australia
Local Institution - 0132
Tamworth New South Wales, 2340, Australia
Local Institution - 0057
South Brisbane Queensland, 4101, Australia
Local Institution - 0130
Ballarat Victoria, 3350, Australia
Local Institution - 0138
Bendigo Victoria, 3550, Australia
Local Institution - 0141
Box Hill Victoria, 3128, Australia
Local Institution - 0109
Frankston Victoria, 3199, Australia
Local Institution - 0119
Murdoch Western Australia, 6150, Australia
Local Institution - 0085
Nedlands Western Australia, 6009, Australia
Local Institution - 0090
Graz , 8036, Austria
Local Institution - 0126
Vienna , 1090, Austria
Local Institution - 0125
Roeselare West-Vlaanderen, 8800, Belgium
Local Institution - 0127
Ghent , 9000, Belgium
Local Institution - 0131
Ghent , 9000, Belgium
Local Institution - 0063
Natal Rio Grande Do Norte, 59062, Brazil
Local Institution - 0161
Ijui Rio Grande Do Sul, 98700, Brazil
Local Institution - 0116
Porto Alegre RIO Grande DO SUL, 90050, Brazil
Local Institution - 0112
Porto Alegre RIO Grande DO SUL, 91350, Brazil
Local Institution - 0107
Barretos Sao Paulo, 14784, Brazil
Local Institution - 0111
Santo Andre SAO Paulo, 09060, Brazil
Local Institution - 0072
Rio de Janeiro , 20231, Brazil
Local Institution - 0163
Sao Paulo , 04014, Brazil
Local Institution - 0120
Sao Paulo , 08270, Brazil
Local Institution - 0041
Santiago Metropolitana, 75007, Chile
Local Institution - 0016
Santiago Metropolitana, 75009, Chile
Local Institution - 0079
Santiago Metropolitana, 84203, Chile
Local Institution - 0008
Rennes Ille-Et-Vilaine, 35000, France
Local Institution - 0007
Dijon cedex , 21079, France
Local Institution - 0144
Le Mans , 72037, France
Local Institution - 0110
Paris , 70005, France
Local Institution - 0102
Paris , 75014, France
Local Institution - 0035
Paris , 75018, France
Local Institution - 0006
Saint-Mande , 94160, France
Local Institution - 0103
Berlin , 12351, Germany
Local Institution - 0045
Berlin , 13585, Germany
Local Institution - 0065
Essen , 45136, Germany
Local Institution - 0062
Grosshansdorf , 22927, Germany
Local Institution - 0058
Homburg , 66421, Germany
Local Institution - 0108
Lowenstein , 74245, Germany
Local Institution - 0071
Marburg , 35043, Germany
Local Institution - 0050
Paderborn , 33098, Germany
Local Institution - 0030
Ravensburg , 88212, Germany
Local Institution - 0133
Dublin , D04 Y, Ireland
Local Institution - 0023
Dublin , D09V2, Ireland
Local Institution - 0106
Rome RA, 00144, Italy
Local Institution - 0028
Candiolo , 10060, Italy
Local Institution - 0009
Catania , 95125, Italy
Local Institution - 0032
Genova Sampierdarena , 16149, Italy
Local Institution - 0059
Milano , 20141, Italy
Local Institution - 0164
Pesaro , 61122, Italy
Local Institution - 0019
Siena , 53100, Italy
Local Institution - 0070
Ciudad de Mexico Distrito Federal, 14050, Mexico
Local Institution - 0020
Toluca de Lerdo Estado DE Mexico, 50090, Mexico
Local Institution - 0115
Monterrey Nuevo LEON, 64710, Mexico
Local Institution - 0013
San Pedro Garza Garcia Nuevo LEON, 66220, Mexico
Local Institution - 0158
Arnhem , 6815 , Netherlands
Local Institution - 0053
Harderwijk , 3844 , Netherlands
Local Institution - 0145
Gdynia , 81-51, Poland
Local Institution - 0036
Lublin , 20-09, Poland
Local Institution - 0031
Lublin , 20-09, Poland
Local Institution - 0080
Olsztyn , 10-35, Poland
Local Institution - 0088
Warszawa , 02-78, Poland
Local Institution - 0099
Cluj Napoca Cluj, 40001, Romania
Local Institution - 0017
Craiova Dolj, 20038, Romania
Local Institution - 0052
Craiova Jud. DOLJ, 20034, Romania
Local Institution - 0069
Timisoara Timis, 30016, Romania
Local Institution
Craiova , 20009, Romania
Arkhangelsk Clinical Oncological Dispensary
Arkhangelsk , 16304, Russian Federation
FSBI ",Research Institute of Influenza named after A.A. Smorodintsev ",of the MoH of the Rus
Saint Petersburg , 19737, Russian Federation
LLC Eurocityclinic
Saint-Petersburg , 19702, Russian Federation
Local Institution - 0042
Malaga Andalucia, 29011, Spain
Local Institution - 0075
Sevilla Andalucia, 41013, Spain
Local Institution - 0137
Badalona Barcelona, 08916, Spain
Local Institution - 0061
Las Palmas de Gran Canaria Las Palmas, 35016, Spain
Local Institution - 0051
A Coruna , 15006, Spain
Local Institution - 0154
Barcelona , 08025, Spain
Local Institution - 0048
Barcelona , 08035, Spain
Local Institution - 0024
Barcelona , 8036, Spain
Local Institution - 0074
Madrid , 28041, Spain
Local Institution - 0123
Madrid , 28046, Spain
Local Institution - 0043
Valencia , 46026, Spain
Local Institution - 0015
Basel , 4031, Switzerland
Local Institution - 0104
St. Gallen , 9007, Switzerland
Local Institution - 0135
Middlesborough Cleveland, TS4 3, United Kingdom
Local Institution - 0101
London Greater London, NW1 2, United Kingdom
Local Institution - 0095
Manchester Lancashire, M20 4, United Kingdom
Local Institution - 0067
Leicester , LE1 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

420

Study ID:

NCT04623775

Recruitment Status:

Active, not recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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