NCT06561386|RecruitingPhase 3DMCFDA Drug

A Study to Compare the Efficacy of Nivolumab and Relatlimab Plus Chemotherapy vs Pembrolizumab Plus Chemotherapy for Stage IV/Recurrent Non-squamous Non-small Cell Lung Cancer With PD-L1 Expression ≥ 1%

RELATIVITY1093

A Phase 3, Randomized, Open-label Study of Nivolumab + Relatlimab Fixed-dose Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy as First-line Treatment for Participants With Non-squamous (NSQ), Stage IV or Recurrent Non-small Cell Lung Cancer and With Tumor Cell PD-L1 Expression ≥ 1%

Bristol-Myers Squibb ClinicalTrials.gov

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3 other identifiers

CA224-10932024-513682-40U1111-1306-8896

Study Type

interventional

Target

1,000

Locations

29 countries

Sites

291

Timeline

RegisteredAug 2024

StartedOct 2024

CompletionAug 2032

Brief Summary

The purpose of this study is to compare the efficacy of Nivolumab and Relatlimab in combination with chemotherapy to Pembrolizumab with Chemotherapy in participants with stage IV or recurrent Non-squamous Non-small Cell Lung Cancer with PD-L1 expression ≥ 1%

Trial Health

On Track

Trial Health Score

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

Strong global presence with extensive site network

Enrollment

1,000

participants targeted

Target at P75+ for phase_3 nonsmall-cell-lung-cancer

Timeline

76mo left

Started Oct 2024

Longer than P75 for phase_3 nonsmall-cell-lung-cancer

Geographic Reach

29 countries

291 active sites

Status

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

7.8 years study duration

Study Progress20%

Oct 2024Aug 2032

First Submitted

Initial submission to the registry

August 16, 2024

Completed

4 days until next milestone

First Posted

Study publicly available on registry

August 20, 2024

Completed

2 months until next milestone

Study Start

First participant enrolled

October 7, 2024

Completed

5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2030

Expected

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2032

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

5.8 years

First QC Date

August 16, 2024

Last Update Submit

April 28, 2026

Conditions

Non-small Cell Lung Cancer

Keywords

Non-squamousPDL-1 ≥ 1%

Outcome Measures

Primary Outcomes (1)

Overall survival (OS) in randomized participants with PD-L1 1% to 49%
Up to 5 years

Secondary Outcomes (8)

OS in randomized participants with PD-L1 ≥ 1%
Up to 5 years
Progression-free survival (PFS) as assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per blinded independent central review (BICR)
Up to 5 years
Overall response rate (ORR)
Up to 5 years
Duration of response (DoR)
Up to 5 years
Number of participants with adverse events (AEs)
Up to 2.5 years
+3 more secondary outcomes

Study Arms (2)

Arm A

EXPERIMENTAL

Drug: NivolumabDrug: RelatlimabDrug: CarboplatinDrug: PemetrexedDrug: Cisplatin

Arm B

ACTIVE COMPARATOR

Drug: PembrolizumabDrug: CarboplatinDrug: PemetrexedDrug: Cisplatin