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)

Non-small Cell Lung Cancer Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04623775
• Other study ID #: CA224-104
• Secondary ID: 2020-004026-31U1
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: February 17, 2021
• Est. completion date: September 16, 2025

Study information

• Verified date: October 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 420
• Est. completion date: September 16, 2025
• Est. primary completion date: May 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Metastatic Non-small Cell Lung Cancer
• Non-small Cell Lung Cancer
• Recurrence
• Recurrent Non-small Cell Lung Cancer

Intervention

Biological:
• Nivolumab
Specified dose on specified days
• Relatlimab
Specified dose on specified days

Drug:
• 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.

Locations

Country	Name	City	State
Argentina	Local Institution - 0021	Buenos Aires	Distrito Federal
Argentina	Local Institution - 0014	Caba	Distrito Federal
Argentina	Local Institution - 0073	Capital	LA Rioja
Argentina	Local Institution - 0038	Cordoba
Argentina	Local Institution - 0060	Cordoba
Argentina	Local Institution - 0037	Rio Cuarto	Cordoba
Argentina	Local Institution - 0029	Rosario	Santa Fe
Argentina	Local Institution - 0039	Viedma	RIO Negro
Australia	Local Institution - 0130	Ballarat	Victoria
Australia	Local Institution - 0138	Bendigo	Victoria
Australia	Local Institution - 0141	Box Hill	Victoria
Australia	Local Institution - 0055	Camperdown	New South Wales
Australia	Local Institution - 0109	Frankston	Victoria
Australia	Local Institution - 0086	Gosford	New South Wales
Australia	Local Institution - 0119	Murdoch	Western Australia
Australia	Local Institution - 0085	Nedlands	Western Australia
Australia	Local Institution - 0057	South Brisbane	Queensland
Australia	Local Institution - 0132	Tamworth	New South Wales
Austria	Local Institution - 0090	Graz
Austria	Local Institution - 0126	Vienna
Belgium	Local Institution - 0127	Ghent
Belgium	Local Institution - 0131	Ghent
Belgium	Local Institution - 0125	Roeselare	West-Vlaanderen
Brazil	Local Institution - 0107	Barretos	Sao Paulo
Brazil	Local Institution - 0161	Ijui	Rio Grande Do Sul
Brazil	Local Institution - 0063	Natal	Rio Grande Do Norte
Brazil	Local Institution - 0112	Porto Alegre	RIO Grande DO SUL
Brazil	Local Institution - 0116	Porto Alegre	RIO Grande DO SUL
Brazil	Local Institution - 0072	Rio de Janeiro
Brazil	Local Institution - 0111	Santo Andre	SAO Paulo
Brazil	Local Institution - 0120	Sao Paulo
Brazil	Local Institution - 0163	Sao Paulo
Chile	Local Institution - 0016	Santiago	Metropolitana
Chile	Local Institution - 0041	Santiago	Metropolitana
Chile	Local Institution - 0079	Santiago	Metropolitana
France	Local Institution - 0007	Dijon cedex
France	Local Institution - 0144	Le Mans
France	Local Institution - 0035	Paris
France	Local Institution - 0102	Paris
France	Local Institution - 0110	Paris
France	Local Institution - 0008	Rennes	Ille-Et-Vilaine
France	Local Institution - 0006	Saint-Mande
Germany	Local Institution - 0045	Berlin
Germany	Local Institution - 0103	Berlin
Germany	Local Institution - 0065	Essen
Germany	Local Institution - 0062	Grosshansdorf
Germany	Local Institution - 0058	Homburg
Germany	Local Institution - 0108	Lowenstein
Germany	Local Institution - 0071	Marburg
Germany	Local Institution - 0050	Paderborn
Germany	Local Institution - 0030	Ravensburg
Ireland	Local Institution - 0023	Dublin
Ireland	Local Institution - 0133	Dublin
Italy	Local Institution - 0028	Candiolo
Italy	Local Institution - 0009	Catania
Italy	Local Institution - 0032	Genova Sampierdarena
Italy	Local Institution - 0059	Milano
Italy	Local Institution - 0164	Pesaro
Italy	Local Institution - 0106	Rome	RA
Italy	Local Institution - 0019	Siena
Mexico	Local Institution - 0070	Ciudad de Mexico	Distrito Federal
Mexico	Local Institution - 0115	Monterrey	Nuevo LEON
Mexico	Local Institution - 0013	San Pedro Garza Garcia	Nuevo LEON
Mexico	Local Institution - 0020	Toluca de Lerdo	Estado DE Mexico
Netherlands	Local Institution - 0158	Arnhem
Netherlands	Local Institution - 0053	Harderwijk
Poland	Local Institution - 0145	Gdynia
Poland	Local Institution - 0031	Lublin
Poland	Local Institution - 0036	Lublin
Poland	Local Institution - 0080	Olsztyn
Poland	Local Institution - 0088	Warszawa
Romania	Local Institution - 0099	Cluj Napoca	Cluj
Romania	Local Institution	Craiova
Romania	Local Institution - 0017	Craiova	Dolj
Romania	Local Institution - 0052	Craiova	Jud. DOLJ
Romania	Local Institution - 0069	Timisoara	Timis
Russian Federation	Arkhangelsk Clinical Oncological Dispensary	Arkhangelsk
Russian Federation	FSBI &quot,Research Institute of Influenza named after A.A. Smorodintsev &quot,of the MoH of the Rus	Saint Petersburg
Russian Federation	LLC Eurocityclinic	Saint-Petersburg
Spain	Local Institution - 0051	A Coruna
Spain	Local Institution - 0137	Badalona	Barcelona
Spain	Local Institution - 0024	Barcelona
Spain	Local Institution - 0048	Barcelona
Spain	Local Institution - 0154	Barcelona
Spain	Local Institution - 0061	Las Palmas de Gran Canaria	Las Palmas
Spain	Local Institution - 0074	Madrid
Spain	Local Institution - 0123	Madrid
Spain	Local Institution - 0042	Malaga	Andalucia
Spain	Local Institution - 0075	Sevilla	Andalucia
Spain	Local Institution - 0043	Valencia
Switzerland	Local Institution - 0015	Basel
Switzerland	Local Institution - 0104	St. Gallen
United Kingdom	Local Institution - 0067	Leicester
United Kingdom	Local Institution - 0101	London	Greater London
United Kingdom	Local Institution - 0095	Manchester	Lancashire
United Kingdom	Local Institution - 0135	Middlesborough	Cleveland
United States	Local Institution - 0089	Athens	Georgia
United States	Local Institution - 0097	Bronx	New York
United States	Local Institution - 0156	Cincinnati	Ohio
United States	Local Institution - 0155	Cleveland	Ohio
United States	Local Institution - 0149	Dallas	Texas
United States	Local Institution - 0160	Duarte	California
United States	Local Institution - 0117	Durham	North Carolina
United States	Local Institution - 0083	Greenville	South Carolina
United States	Local Institution - 0091	Harlingen	Texas
United States	Local Institution - 0152	Howell	New Jersey
United States	Local Institution - 0153	Jacksonville	Florida
United States	Local Institution - 0124	Johnson City	New York
United States	Local Institution - 0084	Lancaster	Pennsylvania
United States	Local Institution - 0159	Lexington	Kentucky
United States	Local Institution - 0002	Louisville	Kentucky
United States	Local Institution - 0162	Mineola	New York
United States	Local Institution - 0157	Morgantown	West Virginia
United States	Local Institution - 0139	New Haven	Connecticut
United States	Local Institution - 0128	New York	New York
United States	Local Institution - 0165	New York	New York
United States	Local Institution - 0129	Omaha	Nebraska
United States	Local Institution - 0081	Orange	California
United States	Local Institution - 0147	Pittsburgh	Pennsylvania
United States	Local Institution - 0011	Port Saint Lucie	Florida
United States	Local Institution - 0148	Providence	Rhode Island
United States	Local Institution - 0082	Scarborough	Maine
United States	Local Institution - 0092	Spokane	Washington
United States	Local Institution - 0001	Tyler	Texas
United States	Local Institution - 0121	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Chile,  France,  Germany,  Ireland,  Italy,  Mexico,  Netherlands,  Poland,  Romania,  Russian Federation,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment-related adverse events (TRAEs) leading to discontinuation within 12 weeks after the first dose	Part 1	Up to 10 months, from first participant's first dose
Primary	Overall Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent clinical review (BICR)	Part 2	10 months after randomization, up to 21 months
Secondary	Incidence of TRAEs leading to discontinuation	Part 1	Up to 10 months, 30 days from participant's last dose
Secondary	Incidence of Adverse Events (AEs)	Part 1	Up to 10 months, 30 days from participant's last dose
Secondary	Incidence of Serious Adverse Events (SAEs)	Part 1	Up to 10 months, 30 days from participant's last dose
Secondary	Incidence of select Adverse Events (AEs)	Part 1	Up to 10 months, 30 days from participant's last dose
Secondary	PFS per RECIST v1.1 by BICR	Part 2	Up to approximately 3 years
Secondary	Overall response rate (ORR) per RECIST v1.1 by BICR	Part 2	Up to approximately 2 years
Secondary	Duration of Response (DoR) per RECIST v1.1 by BICR	Part 2	At 6 months, 12 months, and 18 months
Secondary	Incidence of Adverse Events (AEs)	Part 2	Up to 21 months
Secondary	Incidence of Serious Adverse Events (SAEs)	Part 2	Up to 21 months
Secondary	Incidence of Treatment Related Adverse Events (TRAEs)	Part 2	Up to 21 months
Secondary	Incidence of Immune-mediated Adverse Events (IMAEs)	Part 2	Up to 21 months
Secondary	Incidence of select Adverse Events (AEs)	Part 2	Up to 21 months

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting