Trials / Active Not Recruiting
Active Not RecruitingNCT04623775
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)
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 468 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Nivolumab | Specified dose on specified days |
| BIOLOGICAL | 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. |
| DRUG | Cisplatin | Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy. |
| DRUG | Paclitaxel | Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy. |
| DRUG | Nab-Paclitaxel | Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy. |
| DRUG | Pemetrexed | Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy. |
Timeline
- Start date
- 2021-02-17
- Primary completion
- 2024-01-11
- Completion
- 2026-02-27
- First posted
- 2020-11-10
- Last updated
- 2025-10-20
- Results posted
- 2025-03-18
Locations
125 sites across 19 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Chile, France, Germany, Ireland, Italy, Mexico, Netherlands, Poland, Romania, Russia, Spain, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04623775. Inclusion in this directory is not an endorsement.