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)

Trial Title: 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

Condition: Non-small Cell Lung Cancer
Recurrent Non-small Cell Lung Cancer
Metastatic Non-small Cell Lung Cancer

Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Recurrence
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Nivolumab
Pemetrexed
Relatlimab

Conditions: Keywords:
Stage IV Non-small Cell Lunch Cancer
Recurrent Non-small Cell Lung Cancer
Metastatic Non-small Cell Lung Cancer
Relatlimab
Nivolumab
Chemotherapy

Study type: Interventional

Study phase: Phase 2

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Intervention:

Intervention type: Biological
Intervention name: Nivolumab
Description: Specified dose on specified days
Arm group label: Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT))
Arm group label: Part 1: Arm B (Nivolumab + Relatlimab Dose 2 + PDCT))
Arm group label: Part 2: Arm C (Nivolumab + Relatlimab Dose 2 + PDCT)
Arm group label: Part 2: Arm D (Nivolumab + PDCT)

Intervention type: Biological
Intervention name: Relatlimab
Description: Specified dose on specified days
Arm group label: Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT))
Arm group label: Part 1: Arm B (Nivolumab + Relatlimab Dose 2 + PDCT))
Arm group label: Part 2: Arm C (Nivolumab + Relatlimab Dose 2 + PDCT)

Intervention type: Drug
Intervention name: Carboplatin
Description: Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
Arm group label: Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT))
Arm group label: Part 1: Arm B (Nivolumab + Relatlimab Dose 2 + PDCT))
Arm group label: Part 2: Arm C (Nivolumab + Relatlimab Dose 2 + PDCT)
Arm group label: Part 2: Arm D (Nivolumab + PDCT)

Intervention type: Drug
Intervention name: Cisplatin
Description: Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
Arm group label: Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT))
Arm group label: Part 1: Arm B (Nivolumab + Relatlimab Dose 2 + PDCT))
Arm group label: Part 2: Arm C (Nivolumab + Relatlimab Dose 2 + PDCT)
Arm group label: Part 2: Arm D (Nivolumab + PDCT)

Intervention type: Drug
Intervention name: Paclitaxel
Description: Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
Arm group label: Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT))
Arm group label: Part 1: Arm B (Nivolumab + Relatlimab Dose 2 + PDCT))
Arm group label: Part 2: Arm C (Nivolumab + Relatlimab Dose 2 + PDCT)
Arm group label: Part 2: Arm D (Nivolumab + PDCT)

Intervention type: Drug
Intervention name: Nab-Paclitaxel
Description: Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
Arm group label: Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT))
Arm group label: Part 1: Arm B (Nivolumab + Relatlimab Dose 2 + PDCT))

Intervention type: Drug
Intervention name: Pemetrexed
Description: Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
Arm group label: Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT))
Arm group label: Part 1: Arm B (Nivolumab + Relatlimab Dose 2 + PDCT))
Arm group label: Part 2: Arm C (Nivolumab + Relatlimab Dose 2 + PDCT)
Arm group label: Part 2: Arm D (Nivolumab + PDCT)

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).

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Local Institution - 0160

Address:
City: Duarte
Zip: 91010
Country: United States

Facility:
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Address:
City: Orange
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City: Port Saint Lucie
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Country: United States

Facility:
Name: Local Institution - 0089

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Address:
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Address:
City: Scarborough
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City: Omaha
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City: Howell
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City: Johnson City
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City: Mineola
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Name: Local Institution - 0128

Address:
City: New York
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Name: Local Institution - 0165

Address:
City: New York
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Country: United States

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Name: Local Institution - 0117

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Zip: 45219
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Name: Local Institution - 0155

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City: Cleveland
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Name: Local Institution - 0084

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City: Lancaster
Zip: 17604
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Zip: 15212
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Name: Local Institution - 0091

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City: Harlingen
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Name: Local Institution - 0001

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City: Tyler
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Name: Local Institution - 0092

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City: Spokane
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City: Morgantown
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City: Río Cuarto
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Name: Local Institution - 0021

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City: Buenos Aires
Zip: C1426
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Name: Local Institution - 0014

Address:
City: Cuiudad Autonoma De Buenos Aires
Zip: C1430EGF
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Name: Local Institution - 0039

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City: Viedma
Zip: 8500
Country: Argentina

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Name: Local Institution - 0029

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City: Rosario
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Name: Local Institution - 0060

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City: Cordoba
Zip: 5006
Country: Argentina

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Name: Local Institution - 0038

Address:
City: Cordoba
Zip: X5004FHP
Country: Argentina

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Name: Local Institution - 0073

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City: La Rioja
Zip: F5300COE
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Name: Local Institution - 0055

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City: Camperdown
Zip: 2050
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Name: Local Institution - 0086

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City: Gosford
Zip: 2250
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Name: Local Institution - 0132

Address:
City: Tamworth
Zip: 2340
Country: Australia

Facility:
Name: Local Institution - 0057

Address:
City: South Brisbane
Zip: 4101
Country: Australia

Facility:
Name: Local Institution - 0130

Address:
City: Ballarat
Zip: 3350
Country: Australia

Facility:
Name: Local Institution - 0138

Address:
City: Bendigo
Zip: 3550
Country: Australia

Facility:
Name: Local Institution - 0141

Address:
City: Box Hill
Zip: 3128
Country: Australia

Facility:
Name: Local Institution - 0109

Address:
City: Frankston
Zip: 3199
Country: Australia

Facility:
Name: Local Institution - 0119

Address:
City: Murdoch
Zip: 6150
Country: Australia

Facility:
Name: Local Institution - 0085

Address:
City: Nedlands
Zip: 6009
Country: Australia

Facility:
Name: Local Institution - 0090

Address:
City: Graz
Zip: 8036
Country: Austria

Facility:
Name: Local Institution - 0126

Address:
City: Vienna
Zip: 1090
Country: Austria

Facility:
Name: Local Institution - 0127

Address:
City: Ghent
Zip: 9000
Country: Belgium

Facility:
Name: Local Institution - 0131

Address:
City: Ghent
Zip: 9000
Country: Belgium

Facility:
Name: Local Institution - 0125

Address:
City: Roeselare
Zip: 8800
Country: Belgium

Facility:
Name: Local Institution - 0063

Address:
City: Natal
Zip: 59062 000
Country: Brazil

Facility:
Name: Local Institution - 0161

Address:
City: Ijui
Zip: 98700-000
Country: Brazil

Facility:
Name: Local Institution - 0116

Address:
City: Porto Alegre
Zip: 90050-170
Country: Brazil

Facility:
Name: Local Institution - 0112

Address:
City: Porto Alegre
Zip: 91350-200
Country: Brazil

Facility:
Name: Local Institution - 0107

Address:
City: Barretos
Zip: 14784-400
Country: Brazil

Facility:
Name: Local Institution - 0111

Address:
City: Santo Andre
Zip: 09060-870
Country: Brazil

Facility:
Name: Local Institution - 0072

Address:
City: Rio de Janeiro
Zip: 20220-410
Country: Brazil

Facility:
Name: Local Institution - 0163

Address:
City: Sao Paulo
Zip: 04014-002
Country: Brazil

Facility:
Name: Local Institution - 0120

Address:
City: Sao Paulo
Zip: 08270-120
Country: Brazil

Facility:
Name: Local Institution - 0079

Address:
City: Santiago de Chile
Zip: 0
Country: Chile

Facility:
Name: Local Institution - 0041

Address:
City: Santiago
Zip: 7500713
Country: Chile

Facility:
Name: Local Institution - 0016

Address:
City: Santiago
Zip: 7500921
Country: Chile

Facility:
Name: Local Institution - 0110

Address:
City: Paris
Zip: 75005
Country: France

Facility:
Name: Local Institution - 0008

Address:
City: Rennes
Zip: 35000
Country: France

Facility:
Name: Local Institution - 0007

Address:
City: Dijon
Zip: 21 000
Country: France

Facility:
Name: Local Institution - 0144

Address:
City: Le Mans
Zip: 72037
Country: France

Facility:
Name: Local Institution - 0102

Address:
City: Paris
Zip: 75014
Country: France

Facility:
Name: Local Institution - 0035

Address:
City: Paris
Zip: 75018
Country: France

Facility:
Name: Local Institution - 0006

Address:
City: Saint-Mande
Zip: 94160
Country: France

Facility:
Name: Local Institution - 0065

Address:
City: Essen
Zip: 45136
Country: Germany

Facility:
Name: Local Institution - 0103

Address:
City: Berlin
Zip: 12351
Country: Germany

Facility:
Name: Local Institution - 0045

Address:
City: Berlin
Zip: 13585
Country: Germany

Facility:
Name: Local Institution - 0062

Address:
City: Grosshansdorf
Zip: 22927
Country: Germany

Facility:
Name: Local Institution - 0058

Address:
City: Homburg
Zip: 66421
Country: Germany

Facility:
Name: Local Institution - 0108

Address:
City: Lowenstein
Zip: 74245
Country: Germany

Facility:
Name: Local Institution - 0071

Address:
City: Marburg
Zip: 35043
Country: Germany

Facility:
Name: Local Institution - 0050

Address:
City: Paderborn
Zip: 33098
Country: Germany

Facility:
Name: Local Institution - 0030

Address:
City: Ravensburg
Zip: 88212
Country: Germany

Facility:
Name: Local Institution - 0133

Address:
City: Elm Park
Zip: 4
Country: Ireland

Facility:
Name: Local Institution - 0023

Address:
City: Dublin
Zip: 00009
Country: Ireland

Facility:
Name: Local Institution - 0106

Address:
City: Rome
Zip: 00144
Country: Italy

Facility:
Name: Local Institution - 0028

Address:
City: Candiolo
Zip: 10060
Country: Italy

Facility:
Name: Local Institution - 0009

Address:
City: Catania
Zip: 95125
Country: Italy

Facility:
Name: Local Institution - 0032

Address:
City: Genova
Zip: 16149
Country: Italy

Facility:
Name: Local Institution - 0059

Address:
City: Milano
Zip: 20141
Country: Italy

Facility:
Name: Local Institution - 0164

Address:
City: Pesaro
Zip: 61122
Country: Italy

Facility:
Name: Local Institution - 0019

Address:
City: Siena
Zip: 53100
Country: Italy

Facility:
Name: Local Institution - 0070

Address:
City: Ciudad de Mexico
Zip: 14050
Country: Mexico

Facility:
Name: Local Institution - 0020

Address:
City: Toluca de Lerdo
Zip: 50090
Country: Mexico

Facility:
Name: Local Institution - 0115

Address:
City: Monterrey
Zip: 64710
Country: Mexico

Facility:
Name: Local Institution - 0013

Address:
City: San Pedro Garza Garcia
Zip: 66220
Country: Mexico

Facility:
Name: Local Institution - 0053

Address:
City: Harderwijk
Zip: 3844
Country: Netherlands

Facility:
Name: Local Institution - 0158

Address:
City: Arnhem
Zip: 6815
Country: Netherlands

Facility:
Name: Local Institution - 0145

Address:
City: Gdynia
Zip: 81-519
Country: Poland

Facility:
Name: Local Institution - 0036

Address:
City: Lublin
Zip: 20-090
Country: Poland

Facility:
Name: Local Institution - 0031

Address:
City: Lublin
Zip: 20-093
Country: Poland

Facility:
Name: Local Institution - 0080

Address:
City: Olsztyn
Zip: 10-357
Country: Poland

Facility:
Name: Local Institution - 0088

Address:
City: Warszawa
Zip: 02-781
Country: Poland

Facility:
Name: Local Institution - 0099

Address:
City: Cluj Napoca
Zip: 400015
Country: Romania

Facility:
Name: Local Institution - 0017

Address:
City: Craiova
Zip: 200385
Country: Romania

Facility:
Name: Local Institution - 0012

Address:
City: Craiova
Zip: 200094
Country: Romania

Facility:
Name: Local Institution - 0069

Address:
City: Timisoara
Zip: 300166
Country: Romania

Facility:
Name: Local Institution - 0052

Address:
City: Craiova
Zip: 200347
Country: Romania

Facility:
Name: Arkhangelsk Clinical Oncological Dispensary

Address:
City: Arkhangelsk
Zip: 163045
Country: Russian Federation

Facility:
Name: FSBI ",Research Institute of Influenza named after A.A. Smorodintsev ",of the MoH of the Rus

Address:
City: Saint Petersburg
Zip: 197376
Country: Russian Federation

Facility:
Name: LLC Eurocityclinic

Address:
City: Saint-Petersburg
Zip: 197022
Country: Russian Federation

Facility:
Name: Local Institution - 0075

Address:
City: Sevilla
Zip: 41013
Country: Spain

Facility:
Name: Local Institution - 0137

Address:
City: Badalona
Zip: 08916
Country: Spain

Facility:
Name: Local Institution - 0051

Address:
City: A Coruna
Zip: 15006
Country: Spain

Facility:
Name: Local Institution - 0024

Address:
City: Barcelona
Zip: 08008
Country: Spain

Facility:
Name: Local Institution - 0154

Address:
City: Barcelona
Zip: 08025
Country: Spain

Facility:
Name: Local Institution - 0048

Address:
City: Barcelona
Zip: 08035
Country: Spain

Facility:
Name: Local Institution - 0061

Address:
City: Las Palmas
Zip: 35016
Country: Spain

Facility:
Name: Local Institution - 0074

Address:
City: Madrid
Zip: 28041
Country: Spain

Facility:
Name: Local Institution - 0123

Address:
City: Madrid
Zip: 28046
Country: Spain

Facility:
Name: Local Institution - 0042

Address:
City: Malaga
Zip: 29011
Country: Spain

Facility:
Name: Local Institution - 0043

Address:
City: Valencia
Zip: 46026
Country: Spain

Facility:
Name: Local Institution - 0015

Address:
City: Basel
Zip: 4031
Country: Switzerland

Facility:
Name: Local Institution - 0104

Address:
City: St. Gallen
Zip: 9007
Country: Switzerland

Facility:
Name: Local Institution - 0135

Address:
City: Middlesborough
Zip: TS4 3BW
Country: United Kingdom

Facility:
Name: Local Institution - 0101

Address:
City: London
Zip: NW1 2PG
Country: United Kingdom

Facility:
Name: Local Institution - 0095

Address:
City: Manchester
Zip: M20 4BX
Country: United Kingdom

Facility:
Name: Local Institution - 0067

Address:
City: Leicester
Zip: LE15WW
Country: United Kingdom

Start date: February 17, 2021

Completion date: September 16, 2025

Lead sponsor:
Agency: Bristol-Myers Squibb
Agency class: Industry

Source: Bristol-Myers Squibb

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT04623775
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
https://www.bmsstudyconnect.com/content/studyconnect/us/en/clinical-trials/NCT04623775.html