Clinical trial NCT04623775: 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)
Official title: A Phase 2 Randomized 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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Recurrent Non-small Cell Lung Cancer
Metastatic Non-small Cell Lung Cancer
Keywords: Stage IV Non-small Cell Lunch Cancer
Recurrent Non-small Cell Lung Cancer
Metastatic Non-small Cell Lung Cancer
Relatlimab
Nivolumab
Chemotherapy
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2020-11-10
Enrollment: 468
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: TRAEs Leading to Discontinuation Within 12 Weeks of First Dose in Part 1
timeFrame: from first dose to 12 weeks after first dose
measure: ORR Per RECISTS v1.1 by BICR in Part 2
timeFrame: Approximately 14.8 Months
Secondary outcomes:
measure: TRAEs Leading to Discontinuation in Part 1
timeFrame: From first dose to 30 days post last dose of study therapy (Approximately 32.8 Months)
measure: Number of Participants With a Treatment Related AEs in Part 1
timeFrame: From first dose to 30 days post last dose of study therapy (Approximately 32.8 Months)
measure: Number of Participants With Treatment Releted SAEs in Part 1
timeFrame: From first dose to 30 days post last dose of study therapy (Approximately 32.8 Months)
measure: Number of Participants With Treatment Releted Select AEs in Part 1
timeFrame: From first dose to 30 days post last dose of study therapy (Approximately 32.8 Months)
measure: ORR by PD-L1 Expression Per RECISTS v1.1 by BICR in Part 2
timeFrame: Approximately 14.8 Months
measure: DoR Per RECISTS v1.1 by BICR in Part 2
timeFrame: Approximately up to 13.7 months
measure: Number of Participants With a AE in Part 2
timeFrame: From first dose to 30 days post last dose of study therapy (Approximately 14.8 Months)
measure: Number of Participants With a Treatment Related AEs in Part 2
timeFrame: From first dose to 30 days post last dose of study therapy (Approximately 14.8 Months)
measure: Number of Participants With a Treatment Related SAEs in Part 2
timeFrame: From first dose to 30 days post last dose of study therapy (Approximately 14.8 Months)
measure: Number of Participants With Endocrine Immune-mediated Adverse Events in Part 2
timeFrame: From first dose to 30 days post last dose of study therapy (Approximately 14.8 Months)
measure: ORR by LAG-3 Expression Per RECISTS v1.1 by BICR in Part 2
timeFrame: On Going
measure: ORR by FG-L1 Expression Per RECISTS v1.1 by BICR in Part 2
timeFrame: Ongoing
measure: PFS Per RECISTS v1.1 by BICR in Part 2
timeFrame: Ongoing
measure: PFS by PD-L1 Expression Per RECISTS v1.1 by BICR in Part 2
timeFrame: Ongoing
measure: PFS by LAG-3 Expression Per RECISTS v1.1 by BICR in Part 2
timeFrame: Ongoing
measure: PFS by FG-L1 Expression Per RECISTS v1.1 by BICR in Part 2
timeFrame: Ongoing
measure: Number of Participants With Treatment Releted Select AEs in Part 2
timeFrame: Ongoing
Other outcomes:
Locations:
city: Duarte
country: United States
facility: Local Institution - 0160
state: California
city: Orange
country: United States
facility: Local Institution - 0081
state: California
city: New Haven
country: United States
facility: Local Institution - 0139
state: Connecticut
city: Jacksonville
country: United States
facility: Local Institution - 0153
state: Florida
city: Port Saint Lucie
country: United States
facility: Local Institution - 0011
state: Florida
city: Athens
country: United States
facility: Local Institution - 0089
state: Georgia
city: Wichita
country: United States
facility: Local Institution - 0121
state: Kansas
city: Lexington
country: United States
facility: Local Institution - 0159
state: Kentucky
city: Louisville
country: United States
facility: Local Institution - 0002
state: Kentucky
city: Scarborough
country: United States
facility: Local Institution - 0082
state: Maine
city: Omaha
country: United States
facility: Local Institution - 0129
state: Nebraska
city: Howell
country: United States
facility: Local Institution - 0152
state: New Jersey
city: Bronx
country: United States
facility: Local Institution - 0097
state: New York
city: Johnson City
country: United States
facility: Local Institution - 0124
state: New York
city: Mineola
country: United States
facility: Local Institution - 0162
state: New York
city: New York
country: United States
facility: Local Institution - 0128
state: New York
city: New York
country: United States
facility: Local Institution - 0165
state: New York
city: Durham
country: United States
facility: Local Institution - 0117
state: North Carolina
city: Cincinnati
country: United States
facility: Local Institution - 0156
state: Ohio
city: Cleveland
country: United States
facility: Local Institution - 0155
state: Ohio
city: Lancaster
country: United States
facility: Local Institution - 0084
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Local Institution - 0147
state: Pennsylvania
city: Providence
country: United States
facility: Local Institution - 0148
state: Rhode Island
city: Greenville
country: United States
facility: Local Institution - 0083
state: South Carolina
city: Dallas
country: United States
facility: Local Institution - 0149
state: Texas
city: Harlingen
country: United States
facility: Local Institution - 0091
state: Texas
city: Tyler
country: United States
facility: Local Institution - 0001
state: Texas
city: Spokane
country: United States
facility: Local Institution - 0092
state: Washington
city: Morgantown
country: United States
facility: Local Institution - 0157
state: West Virginia
city: Río Cuarto
country: Argentina
facility: Local Institution - 0037
state: Cordoba
city: Buenos Aires
country: Argentina
facility: Local Institution - 0021
state: Distrito Federal
city: Cuiudad Autonoma De Buenos Aires
country: Argentina
facility: Local Institution - 0014
state: Distrito Federal
city: Viedma
country: Argentina
facility: Local Institution - 0039
state: RIO Negro
city: Rosario
country: Argentina
facility: Local Institution - 0029
state: Santa Fe
city: Cordoba
country: Argentina
facility: Local Institution - 0060
city: Cordoba
country: Argentina
facility: Local Institution - 0038
city: La Rioja
country: Argentina
facility: Local Institution - 0073
city: Camperdown
country: Australia
facility: Local Institution - 0055
state: New South Wales
city: Gosford
country: Australia
facility: Local Institution - 0086
state: New South Wales
city: Tamworth
country: Australia
facility: Local Institution - 0132
state: New South Wales
city: Adelaide
country: Australia
facility: Local Institution - 0057
state: South Australia
city: Ballarat
country: Australia
facility: Local Institution - 0130
state: Victoria
city: Bendigo
country: Australia
facility: Local Institution - 0138
state: Victoria
city: Box Hill
country: Australia
facility: Local Institution - 0141
state: Victoria
city: Frankston
country: Australia
facility: Local Institution - 0109
state: Victoria
city: Murdoch
country: Australia
facility: Local Institution - 0119
state: Western Australia
city: Nedlands
country: Australia
facility: Local Institution - 0085
state: Western Australia
city: Graz
country: Austria
facility: Local Institution - 0090
city: Vienna
country: Austria
facility: Local Institution - 0126
city: Ghent
country: Belgium
facility: Local Institution - 0127
city: Ghent
country: Belgium
facility: Local Institution - 0131
city: Roeselare
country: Belgium
facility: Local Institution - 0125
city: Natal
country: Brazil
facility: Local Institution - 0063
state: Rio Grande Do Norte
city: Ijui
country: Brazil
facility: Local Institution - 0161
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Local Institution - 0116
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Local Institution - 0112
state: RIO Grande DO SUL
city: Barretos
country: Brazil
facility: Local Institution - 0107
state: Sao Paulo
city: Santo Andre
country: Brazil
facility: Local Institution - 0111
state: SAO Paulo
city: Rio de Janeiro
country: Brazil
facility: Local Institution - 0072
city: Sao Paulo
country: Brazil
facility: Local Institution - 0163
city: Sao Paulo
country: Brazil
facility: Local Institution - 0120
city: Santiago de Chile
country: Chile
facility: Local Institution - 0079
state: Metropolitana
city: Santiago
country: Chile
facility: Local Institution - 0041
state: Metropolitana
city: Santiago
country: Chile
facility: Local Institution - 0016
state: Metropolitana
city: Paris
country: France
facility: Local Institution - 0110
state: Ile De France
city: Rennes
country: France
facility: Local Institution - 0008
state: Ille-Et-Vilaine
city: Dijon
country: France
facility: Local Institution - 0007
city: Le Mans
country: France
facility: Local Institution - 0144
city: Paris
country: France
facility: Local Institution - 0102
city: Paris
country: France
facility: Local Institution - 0035
city: Saint-Mande
country: France
facility: Local Institution - 0006
city: Essen
country: Germany
facility: Local Institution - 0065
state: NRW
city: Berlin
country: Germany
facility: Local Institution - 0103
city: Berlin
country: Germany
facility: Local Institution - 0045
city: Grosshansdorf
country: Germany
facility: Local Institution - 0062
city: Homburg
country: Germany
facility: Local Institution - 0058
city: Lowenstein
country: Germany
facility: Local Institution - 0108
city: Marburg
country: Germany
facility: Local Institution - 0071
city: Paderborn
country: Germany
facility: Local Institution - 0050
city: Ravensburg
country: Germany
facility: Local Institution - 0030
city: Elm Park
country: Ireland
facility: Local Institution - 0133
state: Dublin
city: Dublin
country: Ireland
facility: Local Institution - 0023
city: Rome
country: Italy
facility: Local Institution - 0106
state: RA
city: Candiolo
country: Italy
facility: Local Institution - 0028
city: Catania
country: Italy
facility: Local Institution - 0009
city: Genova
country: Italy
facility: Local Institution - 0032
city: Milano
country: Italy
facility: Local Institution - 0059
city: Pesaro
country: Italy
facility: Local Institution - 0164
city: Siena
country: Italy
facility: Local Institution - 0019
city: Ciudad de Mexico
country: Mexico
facility: Local Institution - 0070
state: Distrito Federal
city: Toluca de Lerdo
country: Mexico
facility: Local Institution - 0020
state: Estado DE Mexico
city: Monterrey
country: Mexico
facility: Local Institution - 0115
state: Nuevo LEON
city: San Pedro Garza Garcia
country: Mexico
facility: Local Institution - 0013
state: Nuevo LEON
city: Harderwijk
country: Netherlands
facility: Local Institution - 0053
state: Gelderland
city: Arnhem
country: Netherlands
facility: Local Institution - 0158
city: Gdynia
country: Poland
facility: Local Institution - 0145
city: Lublin
country: Poland
facility: Local Institution - 0036
city: Lublin
country: Poland
facility: Local Institution - 0031
city: Olsztyn
country: Poland
facility: Local Institution - 0080
city: Warszawa
country: Poland
facility: Local Institution - 0088
city: Cluj Napoca
country: Romania
facility: Local Institution - 0099
state: Cluj
city: Craiova
country: Romania
facility: Local Institution - 0017
state: Dolj
city: Craiova
country: Romania
facility: Local Institution - 0012
state: Jud. Dolj
city: Timisoara
country: Romania
facility: Local Institution - 0069
state: Timis
city: Craiova
country: Romania
facility: Local Institution - 0052
city: Arkhangelsk
country: Russian Federation
facility: Arkhangelsk Clinical Oncological Dispensary
city: Saint Petersburg
country: Russian Federation
facility: FSBI &quot,Research Institute of Influenza named after A.A. Smorodintsev &quot,of the MoH of the Rus
city: Saint-Petersburg
country: Russian Federation
facility: LLC Eurocityclinic
city: Sevilla
country: Spain
facility: Local Institution - 0075
state: Andalucia
city: Badalona
country: Spain
facility: Local Institution - 0137
state: Barcelona
city: Barcelona
country: Spain
facility: Local Institution - 0024
state: Cataluna
city: A Coruna
country: Spain
facility: Local Institution - 0051
city: Barcelona
country: Spain
facility: Local Institution - 0154
city: Barcelona
country: Spain
facility: Local Institution - 0048
city: Las Palmas
country: Spain
facility: Local Institution - 0061
city: Madrid
country: Spain
facility: Local Institution - 0074
city: Madrid
country: Spain
facility: Local Institution - 0123
city: Malaga
country: Spain
facility: Local Institution - 0042
city: Valencia
country: Spain
facility: Local Institution - 0043
city: Basel
country: Switzerland
facility: Local Institution - 0015
city: St. Gallen
country: Switzerland
facility: Local Institution - 0104
city: Middlesborough
country: United Kingdom
facility: Local Institution - 0135
state: Cleveland
city: London
country: United Kingdom
facility: Local Institution - 0101
state: Greater London
city: Manchester
country: United Kingdom
facility: Local Institution - 0095
state: Lancashire
city: Leicester
country: United Kingdom
facility: Local Institution - 0067
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: