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)

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).

Timeline

Start

2021-02-17

Primary completion

2024-01-11

Completion

2026-05-06

Outcome

Missed primary endpoint

registry analysis (superiority test); Part 1: Treatment A vs Part 1: Treatment B; Risk Difference (RD) -6.5 (95% CI -16.0 to 3.0) NCT04623775 ↗

registry analysis (superiority test); Part 2: Treatment C vs Part 2: Treatment D; Odds Ratio (OR) 1.39 (90% CI 0.94 to 2.05); Cochran-Mantel-Haenszel NCT04623775 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Relatlimab	Monoclonal antibody	—	—
Background	Carboplatin	Small molecule	—	—
Background	Cisplatin	Other / unclassified	—	—
Background	Nab-paclitaxel	Small molecule	—	—
Background	Nivolumab	Monoclonal antibody	—	—
Background	Paclitaxel	Small molecule	—	—
Background	Pemetrexed	Small molecule	—	—

Indications