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 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)
The purpose of this study is to assess the safety profile of nivolumab plus relatlimab in combination with platinum doublet chemotherapy (PDCT) and to determine if nivolumab plus relatlimab in combination with PDCT improves progression free survival (PFS) when compared to nivolumab plus PDCT in participants with previously untreated Stage IV or recurrent non-small cell lung cancer (NSCLC).
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 520 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2 Randomized Double-blind 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)
Actual Study Start Date: February 17, 2021
Estimated Primary Completion Date: February 27, 2024
Estimated Study Completion Date: February 28, 2024
Arm:
- Experimental: Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT))
- Experimental: Part 1: Arm B (Nivolumab + Relatlimab Dose 2 + PDCT))
- Experimental: Part 2: Arm C (Nivolumab + Relatlimab Dose 1 or Dose 2 + PDCT)
- Placebo Comparator: Part 2: Arm D (Nivolumab + Placebo + PDCT)
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 520 |
| Actual Study start date | 17 February 2021 |
| Estimated Study Completion Date | 28 February 2024 |