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)
NCT ID: NCT04623775
Last Updated: 2025-10-20
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE2
468 participants
INTERVENTIONAL
2021-02-17
2026-02-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT))
Nivolumab
Specified dose on specified days
Relatlimab
Specified dose on specified days
Carboplatin
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
Cisplatin
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
Paclitaxel
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
Nab-Paclitaxel
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
Pemetrexed
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
Part 1: Arm B (Nivolumab + Relatlimab Dose 2 + PDCT))
Nivolumab
Specified dose on specified days
Relatlimab
Specified dose on specified days
Carboplatin
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
Cisplatin
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
Paclitaxel
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
Nab-Paclitaxel
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
Pemetrexed
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
Part 2: Arm C (Nivolumab + Relatlimab Dose 2 + PDCT)
Nivolumab
Specified dose on specified days
Relatlimab
Specified dose on specified days
Carboplatin
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
Cisplatin
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
Paclitaxel
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
Pemetrexed
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
Part 2: Arm D (Nivolumab + PDCT)
Nivolumab
Specified dose on specified days
Carboplatin
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
Cisplatin
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
Paclitaxel
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
Pemetrexed
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
Interventions
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Nivolumab
Specified dose on specified days
Relatlimab
Specified dose on specified days
Carboplatin
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
Cisplatin
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
Paclitaxel
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
Nab-Paclitaxel
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
Pemetrexed
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0160
Duarte, California, United States
Local Institution - 0081
Orange, California, United States
Local Institution - 0139
New Haven, Connecticut, United States
Local Institution - 0153
Jacksonville, Florida, United States
Local Institution - 0011
Port Saint Lucie, Florida, United States
Local Institution - 0089
Athens, Georgia, United States
Local Institution - 0121
Wichita, Kansas, United States
Local Institution - 0159
Lexington, Kentucky, United States
Local Institution - 0002
Louisville, Kentucky, United States
Local Institution - 0082
Scarborough, Maine, United States
Local Institution - 0129
Omaha, Nebraska, United States
Local Institution - 0152
Howell Township, New Jersey, United States
Local Institution - 0124
Johnson City, New York, United States
Local Institution - 0162
Mineola, New York, United States
Local Institution - 0128
New York, New York, United States
Local Institution - 0165
New York, New York, United States
Local Institution - 0097
The Bronx, New York, United States
Local Institution - 0117
Durham, North Carolina, United States
Local Institution - 0156
Cincinnati, Ohio, United States
Local Institution - 0155
Cleveland, Ohio, United States
Local Institution - 0084
Lancaster, Pennsylvania, United States
Local Institution - 0147
Pittsburgh, Pennsylvania, United States
Local Institution - 0148
Providence, Rhode Island, United States
Local Institution - 0083
Greenville, South Carolina, United States
Local Institution - 0149
Dallas, Texas, United States
Local Institution - 0091
Harlingen, Texas, United States
Local Institution - 0001
Tyler, Texas, United States
Local Institution - 0092
Spokane, Washington, United States
Local Institution - 0157
Morgantown, West Virginia, United States
Local Institution - 0037
Río Cuarto, Córdoba Province, Argentina
Local Institution - 0021
Buenos Aires, Distrito Federal, Argentina
Local Institution - 0014
Cuiudad Autonoma de Buenos Aires, Distrito Federal, Argentina
Local Institution - 0039
Viedma, Río Negro Province, Argentina
Local Institution - 0029
Rosario, Santa Fe Province, Argentina
Local Institution - 0060
Córdoba, , Argentina
Local Institution - 0038
Córdoba, , Argentina
Local Institution - 0073
La Rioja, , Argentina
Local Institution - 0055
Camperdown, New South Wales, Australia
Local Institution - 0086
Gosford, New South Wales, Australia
Local Institution - 0132
Tamworth, New South Wales, Australia
Local Institution - 0057
Adelaide, South Australia, Australia
Local Institution - 0130
Ballarat, Victoria, Australia
Local Institution - 0138
Bendigo, Victoria, Australia
Local Institution - 0141
Box Hill, Victoria, Australia
Local Institution - 0109
Frankston, Victoria, Australia
Local Institution - 0119
Murdoch, Western Australia, Australia
Local Institution - 0085
Nedlands, Western Australia, Australia
Local Institution - 0090
Graz, , Austria
Local Institution - 0126
Vienna, , Austria
Local Institution - 0127
Ghent, , Belgium
Local Institution - 0131
Ghent, , Belgium
Local Institution - 0125
Roeselare, , Belgium
Local Institution - 0063
Natal, Rio Grande do Norte, Brazil
Local Institution - 0161
Ijuí, Rio Grande do Sul, Brazil
Local Institution - 0116
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0112
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0107
Barretos, São Paulo, Brazil
Local Institution - 0111
Santo André, São Paulo, Brazil
Local Institution - 0072
Rio de Janeiro, , Brazil
Local Institution - 0163
São Paulo, , Brazil
Local Institution - 0120
São Paulo, , Brazil
Local Institution - 0079
Santiago, Santiago Metropolitan, Chile
Local Institution - 0041
Santiago, Santiago Metropolitan, Chile
Local Institution - 0016
Santiago, Santiago Metropolitan, Chile
Local Institution - 0008
Rennes, Ille-Et-Vilaine, France
Local Institution - 0007
Dijon, , France
Local Institution - 0144
Le Mans, , France
Local Institution - 0102
Paris, , France
Local Institution - 0035
Paris, , France
Local Institution - 0006
Saint-Mandé, , France
Local Institution - 0110
Paris, Île-de-France Region, France
Local Institution - 0065
Essen, North Rhine-Westphalia, Germany
Local Institution - 0103
Berlin, , Germany
Local Institution - 0045
Berlin, , Germany
Local Institution - 0062
Großhansdorf, , Germany
Local Institution - 0058
Homburg, , Germany
Local Institution - 0108
Löwenstein, , Germany
Local Institution - 0071
Marburg, , Germany
Local Institution - 0050
Paderborn, , Germany
Local Institution - 0030
Ravensburg, , Germany
Local Institution - 0133
Elm Park, Dublin, Ireland
Local Institution - 0023
Dublin, , Ireland
Local Institution - 0106
Rome, RA, Italy
Local Institution - 0028
Candiolo, , Italy
Local Institution - 0009
Catania, , Italy
Local Institution - 0032
Genova, , Italy
Local Institution - 0059
Milan, , Italy
Local Institution - 0164
Pesaro, , Italy
Local Institution - 0019
Siena, , Italy
Local Institution - 0070
Mexico City, Mexico City, Mexico
Local Institution - 0115
Monterrey, Nuevo León, Mexico
Local Institution - 0013
San Pedro Garza García, Nuevo León, Mexico
Local Institution - 0020
Toluca, State of Mexico, Mexico
Local Institution - 0053
Harderwijk, Gelderland, Netherlands
Local Institution - 0158
Arnhem, , Netherlands
Local Institution - 0145
Gdynia, , Poland
Local Institution - 0036
Lublin, , Poland
Local Institution - 0031
Lublin, , Poland
Local Institution - 0080
Olsztyn, , Poland
Local Institution - 0088
Warsaw, , Poland
Local Institution - 0099
Cluj-Napoca, Cluj, Romania
Local Institution - 0017
Craiova, Dolj, Romania
Local Institution - 0012
Craiova, Jud. Dolj, Romania
Local Institution - 0069
Timișoara, Timiș County, Romania
Local Institution - 0052
Craiova, , Romania
Arkhangelsk Clinical Oncological Dispensary
Arkhangelsk, , Russia
LLC Eurocityclinic
Saint Petersburg, , Russia
FSBI ",Research Institute of Influenza named after A.A. Smorodintsev ",of the MoH of the Rus
Saint Petersburg, , Russia
Local Institution - 0075
Seville, Andalusia, Spain
Local Institution - 0137
Badalona, Barcelona, Spain
Local Institution - 0024
Barcelona, Catalonia, Spain
Local Institution - 0051
A Coruña, , Spain
Local Institution - 0154
Barcelona, , Spain
Local Institution - 0048
Barcelona, , Spain
Local Institution - 0061
Las Palmas, , Spain
Local Institution - 0074
Madrid, , Spain
Local Institution - 0123
Madrid, , Spain
Local Institution - 0042
Málaga, , Spain
Local Institution - 0043
Valencia, , Spain
Local Institution - 0015
Basel, , Switzerland
Local Institution - 0104
Sankt Gallen, , Switzerland
Local Institution - 0135
Middlesbrough, Cleveland, United Kingdom
Local Institution - 0101
London, Greater London, United Kingdom
Local Institution - 0095
Manchester, Lancashire, United Kingdom
Local Institution - 0067
Leicester, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2020-004026-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1256-8115
Identifier Type: REGISTRY
Identifier Source: secondary_id
CA224-104
Identifier Type: -
Identifier Source: org_study_id
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