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:

Recruiting

Sponsor:

Bristol-Myers Squibb

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 145 Locations for this study

See Locations Near You

City Of Hope
Arcadia California, 91006, United States More Info
James Shen, Site 0160
Contact
626-218-5167
University of California Irvine
Orange California, 92868, United States More Info
Sai-Hong Ou, Site 0081
Contact
714-456-2242
Local Institution
Santa Monica California, 90404, United States More Info
Site 0134
Contact
Yale School of Medicine - Smilow Cancer Hospital
New Haven Connecticut, 06520, United States More Info
Scott Gettinger, Site 0139
Contact
203-980-2689
Local Institution
Newark Delaware, 19713, United States
Cancer Specialists Of North Florida
Jacksonville Florida, 32204, United States More Info
Ayed Ayed, Site 0153
Contact
352-328-5647
Local Institution - 0011
Port Saint Lucie Florida, 34952, United States
Local Institution - 0089
Athens Georgia, 30607, United States
Cancer Center of Kansas
Wichita Kansas, 67214, United States More Info
Shaker Dakhil, Site 0121
Contact
316-262-4467
Baptist Health Lexington
Lexington Kentucky, 40503, United States More Info
Firas Badin, Site 0159
Contact
859-260-6100
Norton Cancer Institute
Louisville Kentucky, 40241, United States More Info
Adam Lye, Site 0002
Contact
859-323-3000
NECS
Scarborough Maine, 04074, United States More Info
Christian Thomas, Site 0082
Contact
802-655-3400
Oncology Hematology West P.C. dba Nebraska Cancer Specialist
Omaha Nebraska, 68130, United States More Info
Ralph Hauke, Site 0129
Contact
402-334-4773
Regional Cancer Care Associates
Howell New Jersey, 07731, United States More Info
Kenneth Nahum, Site 0152
Contact
732-367-1535
Montefiore Medical Center
Bronx New York, 10461, United States More Info
Balazs Halmos, Site 0097
Contact
212-305-5874
Broome Oncology LLC
Johnson City New York, 13790, United States More Info
Ronald Harris, Site 0124
Contact
607-763-6850
NYU Perlmutter Cancer Center (Long Island)
Mineola New York, 11501, United States More Info
Vamsidhar Velcheti, Site 0162
Contact
216-903-4153
NYU Perlmutter Cancer Center
New York New York, 10016, United States More Info
Vamsidhar Velcheti, Site 0128
Contact
216-903-4153
Memorial Sloan Kettering Cancer Center
New York New York, 10021, United States More Info
Adam Schoenfeld, Site 0165
Contact
347-640-2197
Duke University Medical Center
Durham North Carolina, 27710, United States More Info
Neal Ready, Site 0117
Contact
919-684-8239
University of Cincinnati Cancer Institute
Cincinnati Ohio, 45219, United States More Info
Muhammad Riaz, Site 0156
Contact
513-558-2104
The MetroHealth System
Cleveland Ohio, 44109, United States More Info
Tonjeh Bah, Site 0155
Contact
216-778-1393
Lancaster General Health
Lancaster Pennsylvania, 17604, United States More Info
Samuel Kerr, Site 0084
Contact
717-544-9400
Allegheny General Hospital
Pittsburgh Pennsylvania, 15212, United States More Info
Gene Finley, Site 0147
Contact
412-298-0123
Lifespan Cancer Institute
Providence Rhode Island, 02903, United States More Info
Christopher Azzoli, Site 0148
Contact
646-888-4261
St Francis Cancer Center
Greenville South Carolina, 29607, United States More Info
Robert Siegel, Site 0083
Contact
864-360-7583
UT Southwestern Medical Center
Dallas Texas, 75060, United States More Info
Sawsan Rashdan, Site 0149
Contact
317-919-0026
Valley Cancer Associates PC
Harlingen Texas, 78550, United States More Info
Todd Shenkenberg, Site 0091
Contact
The University of Texas Health Science Center at Tyler DBA UT Health East Texas Hope Cancer Center
Tyler Texas, 75701, United States More Info
Arielle Lee, Site 0001
Contact
903-592-6152
Medical Oncology Associates, PS (dba Summit Cancer Centers)
Spokane Washington, 99208, United States More Info
Arvind Chaudhry, Site 0092
Contact
509-462-2273
West Virginia University
Morgantown West Virginia, 26506, United States More Info
Ruta Arays, Site 0157
Contact
304-598-6984
Local Institution - 0037
Rio Cuarto Cordoba, 5800, Argentina More Info
Site 0037
Contact
Local Institution - 0021
Buenos Aires Distrito Federal, C1426, Argentina More Info
Site 0021
Contact
Local Institution - 0014
Caba Distrito Federal, 1430, Argentina More Info
Site 0014
Contact
Local Institution - 0073
Capital LA Rioja, 5300, Argentina More Info
Site 0073
Contact
Local Institution - 0039
Viedma RIO Negro, 8500, Argentina More Info
Site 0039
Contact
Local Institution - 0029
Rosario Santa Fe, 2000, Argentina More Info
Site 0029
Contact
Local Institution - 0060
Cordoba , 5006, Argentina More Info
Site 0060
Contact
Local Institution - 0038
Cordoba , X5004, Argentina More Info
Site 0038
Contact
Local Institution - 0055
Camperdown New South Wales, 2050, Australia More Info
Site 0055
Contact
Local Institution - 0086
Gosford New South Wales, 2250, Australia More Info
Site 0086
Contact
Local Institution - 0132
Tamworth New South Wales, 2340, Australia More Info
Site 0132
Contact
Local Institution - 0057
South Brisbane Queensland, 4101, Australia More Info
Site 0057
Contact
Local Institution - 0130
Ballarat Victoria, 3350, Australia More Info
Site 0130
Contact
Local Institution - 0138
Bendigo Victoria, 3550, Australia More Info
Site 0138
Contact
Local Institution - 0141
Box Hill Victoria, 3128, Australia More Info
Site 0141
Contact
Local Institution - 0109
Frankston Victoria, 3199, Australia More Info
Site 0109
Contact
Local Institution - 0119
Murdoch Western Australia, 6150, Australia More Info
Site 0119
Contact
Local Institution - 0085
Nedlands Western Australia, 6009, Australia More Info
Site 0085
Contact
Local Institution - 0090
Graz , 8036, Austria More Info
Site 0090
Contact
Local Institution - 0126
Vienna , 1090, Austria More Info
Site 0126
Contact
Local Institution - 0066
Liege Lige, 4000, Belgium
Local Institution - 0125
Roeselare West-Vlaanderen, 8800, Belgium More Info
Site 0125
Contact
Local Institution - 0127
Ghent , 9000, Belgium More Info
Site 0127
Contact
Local Institution - 0131
Ghent , 9000, Belgium More Info
Site 0131
Contact
Local Institution - 0063
Natal RIO Grande DO Norte, 59075, Brazil More Info
Site 0063
Contact
Local Institution - 0161
Ijui RIO Grande DO SUL, 98700, Brazil More Info
Site 0161
Contact
Local Institution - 0116
Porto Alegre RIO Grande DO SUL, 90050, Brazil More Info
Site 0116
Contact
Local Institution - 0112
Porto Alegre RIO Grande DO SUL, 91350, Brazil More Info
Site 0112
Contact
Local Institution - 0107
Barretos Sao Paulo, 14784, Brazil More Info
Site 0107
Contact
Local Institution - 0111
Santo Andre SAO Paulo, 09060, Brazil More Info
Site 0111
Contact
Local Institution
Sao-Paulo SAO Paulo, 03102, Brazil
Local Institution - 0072
Rio de Janeiro , 20231, Brazil More Info
Site 0072
Contact
Local Institution - 0163
Sao Paulo , 04014, Brazil More Info
Site 0163
Contact
Local Institution - 0120
Sao Paulo , 08270, Brazil More Info
Site 0120
Contact
Local Institution - 0041
Santiago Metropolitana, 75007, Chile More Info
Site 0041
Contact
Local Institution - 0016
Santiago Metropolitana, 75009, Chile More Info
Site 0016
Contact
Local Institution - 0079
Santiago Metropolitana, 84203, Chile More Info
Site 0079
Contact
Local Institution - 0008
Rennes Ille-Et-Vilaine, 35000, France More Info
Site 0008
Contact
Local Institution
Bordeaux , 33076, France
Local Institution - 0007
Dijon cedex , 21079, France More Info
Site 0007
Contact
Local Institution - 0144
Le Mans , 72037, France More Info
Site 0144
Contact
Local Institution - 0110
Paris , 70005, France More Info
Site 0110
Contact
Local Institution - 0102
Paris , 75014, France More Info
Site 0102
Contact
Local Institution - 0035
Paris , 75018, France More Info
Site 0035
Contact
Local Institution
Saint Priest en Jarez , 42271, France
Local Institution - 0006
Saint-Mande , 94160, France More Info
Site 0006
Contact
Local Institution - 0103
Berlin , 12351, Germany More Info
Site 0103
Contact
Local Institution - 0045
Berlin , 13585, Germany More Info
Site 0045
Contact
Local Institution
Dresden , 01307, Germany More Info
Site 0077
Contact
Local Institution - 0065
Essen , 45136, Germany More Info
Site 0065
Contact
Local Institution - 0062
Grosshansdorf , 22927, Germany More Info
Site 0062
Contact
Local Institution - 0058
Homburg , 66421, Germany More Info
Site 0058
Contact
Local Institution - 0108
Lowenstein , 74245, Germany More Info
Site 0108
Contact
Local Institution - 0071
Marburg , 35043, Germany More Info
Site 0071
Contact
Local Institution - 0050
Paderborn , 33098, Germany More Info
Site 0050
Contact
Local Institution - 0030
Ravensburg , 88212, Germany More Info
Site 0030
Contact
Local Institution - 0133
Dublin , D04 Y, Ireland More Info
Site 0133
Contact
Local Institution - 0023
Dublin , D09V2, Ireland More Info
Site 0023
Contact
Local Institution - 0106
Rome RA, 00144, Italy More Info
Site 0106
Contact
Local Institution - 0028
Candiolo , 10060, Italy More Info
Site 0028
Contact
Local Institution - 0009
Catania , 95123, Italy More Info
Site 0009
Contact
Local Institution - 0032
Genova Sampierdarena , 16149, Italy More Info
Site 0032
Contact
Local Institution - 0059
Milano , 20141, Italy More Info
Site 0059
Contact
Local Institution
Monselice , 35043, Italy
Local Institution - 0164
Pesaro , 61122, Italy More Info
Site 0164
Contact
Local Institution
Ravenna , 48121, Italy
Local Institution - 0019
Siena , 53100, Italy More Info
Site 0019
Contact
Local Institution - 0070
Ciudad de Mexico Distrito Federal, 14050, Mexico More Info
Site 0070
Contact
Local Institution - 0020
Toluca de Lerdo Estado DE Mexico, 50090, Mexico More Info
Site 0020
Contact
Local Institution - 0115
Monterrey Nuevo LEON, 64710, Mexico More Info
Site 0115
Contact
Local Institution - 0013
San Pedro Garza Garcia Nuevo LEON, 66220, Mexico More Info
Site 0013
Contact
Local Institution - 0158
Arnhem , 6815 , Netherlands More Info
Site 0158
Contact
Local Institution - 0053
Harderwijk , 3844 , Netherlands More Info
Site 0053
Contact
Local Institution
Christchurch , 8013, New Zealand
Local Institution - 0145
Gdynia , 81-51, Poland More Info
Site 0145
Contact
Local Institution - 0036
Lublin , 20-09, Poland More Info
Site 0036
Contact
Local Institution - 0031
Lublin , 20-09, Poland More Info
Site 0031
Contact
Local Institution - 0080
Olsztyn , 10-35, Poland More Info
Site 0080
Contact
Local Institution - 0088
Warszawa , 02-78, Poland More Info
Site 0088
Contact
Local Institution - 0099
Cluj Napoca Cluj, 40001, Romania More Info
Site 0099
Contact
Local Institution - 0017
Craiova Dolj, 20038, Romania More Info
Site 0017
Contact
Local Institution - 0052
Craiova Jud. DOLJ, 20034, Romania More Info
Site 0052
Contact
Local Institution - 0069
Timisoara Timis, 30016, Romania More Info
Site 0069
Contact
Local Institution
Baia Mare , 43003, Romania
Local Institution
Craiova , 20009, Romania More Info
Site 0012
Contact
Arkhangelsk Clinical Oncological Dispensary
Arkhangelsk , 16304, Russian Federation
Local Institution - 0054
Moscow , 11547, Russian Federation
Local Institution
Moscow , , Russian Federation
Local Institution
Nizghiy Novgorod , 60300, 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 More Info
Site 0042
Contact
Local Institution - 0075
Sevilla Andalucia, 41013, Spain More Info
Site 0075
Contact
Local Institution - 0137
Badalona Barcelona, 08916, Spain More Info
Site 0137
Contact
Local Institution - 0061
Las Palmas de Gran Canaria Las Palmas, 35016, Spain More Info
Site 0061
Contact
Local Institution - 0051
A Coruna , 15006, Spain More Info
Site 0051
Contact
Local Institution - 0154
Barcelona , 08025, Spain More Info
Site 0154
Contact
Local Institution - 0048
Barcelona , 08035, Spain More Info
Site 0048
Contact
Local Institution - 0024
Barcelona , 8036, Spain More Info
Site 0024
Contact
Local Institution - 0074
Madrid , 28041, Spain More Info
Site 0074
Contact
Local Institution - 0123
Madrid , 28046, Spain More Info
Site 0123
Contact
Local Institution - 0043
Valencia , 46026, Spain More Info
Site 0043
Contact
Local Institution - 0015
Basel , 4031, Switzerland More Info
Site 0015
Contact
Local Institution - 0104
St. Gallen , 9007, Switzerland More Info
Site 0104
Contact
Local Institution
Adana , 1330, Turkey
Local Institution - 0068
Ankara , 06490, Turkey More Info
Site 0068
Contact
Local Institution - 0034
Antalya , 07059, Turkey More Info
Site 0034
Contact
Local Institution - 0114
Diyarbakir , 21280, Turkey More Info
Site 0114
Contact
Local Institution - 0018
Edirne , 22030, Turkey More Info
Site 0018
Contact
Local Institution
Erzurum , 25240, Turkey
Local Institution
Istanbul , 34098, Turkey
Local Institution - 0046
Istanbul , 34722, Turkey More Info
Site 0046
Contact
Local Institution - 0135
Middlesborough Cleveland, TS4 3, United Kingdom More Info
Site 0135
Contact
Local Institution - 0136
Blackpool Lancashire, FY3 8, United Kingdom
Local Institution - 0095
Manchester Lancashire, M20 4, United Kingdom More Info
Site 0095
Contact
Local Institution
Guildford Surrey, GU2 7, United Kingdom
Local Institution - 0067
Leicester , LE1 5, United Kingdom More Info
Site 0067
Contact
Local Institution
London , NW1 2, United Kingdom More Info
Site 0101
Contact
Local Institution - 0140
Nottingham , NG7 2, United Kingdom More Info
Site 0140
Contact

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:

Recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.