Trials / Recruiting
RecruitingNCT07361510
A Study to Evaluate the Efficacy of Pumitamig Versus Pembrolizumab in Participants With Previously Untreated Advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%. (ROSETTA Lung-202)
ROSETTA Lung-202: A Randomized, Double-Blind, Phase 3 Study of Pumitamig Monotherapy Compared to Pembrolizumab as First-line Treatment in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With PD-L1 ≥ 50%.
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 750 (estimated)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy of Pumitamig versus Pembrolizumab in participants with previously untreated advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pumitamig | Specified dose on specified days |
| DRUG | Pembrolizumab | Specified dose on specified days |
Timeline
- Start date
- 2026-03-12
- Primary completion
- 2031-10-14
- Completion
- 2031-10-14
- First posted
- 2026-01-23
- Last updated
- 2026-04-15
Locations
271 sites across 36 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, Finland, France, Germany, Hungary, India, Italy, Japan, Malaysia, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Romania, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07361510. Inclusion in this directory is not an endorsement.