NCT04623775|Active Not RecruitingPhase 2ResultsDMCFDA Drug

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)

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)

Bristol-Myers Squibb ClinicalTrials.gov

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3 other identifiers

CA224-1042020-004026-31U1111-1256-8115

Study Type

interventional

Target

468

Locations

18 countries

Sites

123

Timeline

RegisteredNov 2020

StartedFeb 2021

CompletionFeb 2026

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).

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Strong global presence with extensive site network

Enrollment

468

participants targeted

Target at P75+ for phase_2 nonsmall-cell-lung-cancer

Timeline

Completed

Started Feb 2021

Typical duration for phase_2 nonsmall-cell-lung-cancer

Geographic Reach

18 countries

123 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5 years study duration

First Submitted

Initial submission to the registry

November 5, 2020

Completed

5 days until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed

3 months until next milestone

Study Start

First participant enrolled

February 17, 2021

Completed

2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2024

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

March 18, 2025

Completed

12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2026

Completed

Last Updated

October 20, 2025

Status Verified

October 1, 2025

Enrollment Period

2.9 years

First QC Date

November 5, 2020

Results QC Date

January 10, 2025

Last Update Submit

October 10, 2025

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 CancerRecurrent Non-small Cell Lung CancerMetastatic Non-small Cell Lung CancerRelatlimabNivolumabChemotherapy

Outcome Measures

Primary Outcomes (2)

TRAEs Leading to Discontinuation Within 12 Weeks of First Dose in Part 1
Percentage of participants with treatment related adverse events (TRAEs) leading to discontinuation within 12 weeks of first dose. AE is defined as any new untoward medical occurrence or worsenig of a preexising medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Grading will be determined for severity according to the NCI CTCAE v5.0.
from first dose to 12 weeks after first dose
ORR Per RECISTS v1.1 by BICR in Part 2
Objective Response Rate (ORR) per RECIST v1.1 by BICR is defined as the number of participants in the randomized population who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments (using RECIST v1.1) divided by the number of participants in the population. BOR is defined as the best response, as determined by the BICR, recorded between the date of randomization and the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first.
Approximately 14.8 Months

Secondary Outcomes (17)

TRAEs Leading to Discontinuation in Part 1
From first dose to 30 days post last dose of study therapy (Approximately 32.8 Months)
Number of Participants With a Treatment Related AEs in Part 1
From first dose to 30 days post last dose of study therapy (Approximately 32.8 Months)
Number of Participants With Treatment Releted SAEs in Part 1
From first dose to 30 days post last dose of study therapy (Approximately 32.8 Months)
Number of Participants With Treatment Releted Select AEs in Part 1
From first dose to 30 days post last dose of study therapy (Approximately 32.8 Months)
ORR by PD-L1 Expression Per RECISTS v1.1 by BICR in Part 2
Approximately 14.8 Months
+12 more secondary outcomes

Study Arms (4)

Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT))

EXPERIMENTAL

Biological: NivolumabBiological: RelatlimabDrug: CarboplatinDrug: CisplatinDrug: PaclitaxelDrug: Nab-PaclitaxelDrug: Pemetrexed

Part 1: Arm B (Nivolumab + Relatlimab Dose 2 + PDCT))

EXPERIMENTAL

Biological: NivolumabBiological: RelatlimabDrug: CarboplatinDrug: CisplatinDrug: PaclitaxelDrug: Nab-PaclitaxelDrug: Pemetrexed

Part 2: Arm C (Nivolumab + Relatlimab Dose 2 + PDCT)

EXPERIMENTAL

Biological: NivolumabBiological: RelatlimabDrug: CarboplatinDrug: CisplatinDrug: PaclitaxelDrug: Pemetrexed

Part 2: Arm D (Nivolumab + PDCT)

ACTIVE COMPARATOR

Biological: NivolumabDrug: CarboplatinDrug: CisplatinDrug: PaclitaxelDrug: Pemetrexed

Interventions

NivolumabBIOLOGICAL

Specified dose on specified days

Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT))Part 1: Arm B (Nivolumab + Relatlimab Dose 2 + PDCT))Part 2: Arm C (Nivolumab + Relatlimab Dose 2 + PDCT)Part 2: Arm D (Nivolumab + PDCT)

RelatlimabBIOLOGICAL

Specified dose on specified days

Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT))Part 1: Arm B (Nivolumab + Relatlimab Dose 2 + PDCT))Part 2: Arm C (Nivolumab + Relatlimab Dose 2 + PDCT)

CarboplatinDRUG