Trials / Active Not Recruiting
Active Not RecruitingNCT06472076
A Study of Belrestotug Plus Dostarlimab Compared With Placebo Plus Pembrolizumab in Previously Untreated Participants With Programmed Death Ligand 1 (PD-L1) High Non-small-cell Lung Cancer (NSCLC)
A Randomized, Multicenter, Double-blind, Phase 3 Study to Investigate the Safety and Efficacy of Belrestotug in Combination With Dostarlimab Compared With Placebo in Combination With Pembrolizumab in Participants With Previously Untreated, Unresectable, Locally Advanced or Metastatic PD-L1 Selected Non-small Cell Lung Cancer (GALAXIES Lung-301)
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 88 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this clinical trial is to evaluate the safety and tolerability profile of dostarlimab in combination with belrestotug when compared with pembrolizumab and placebo in participants with previously untreated, unresectable, locally advanced or metastatic PD-L1 high NSCLC.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Dostarlimab | Dostarlimab will be administered. |
| BIOLOGICAL | Belrestotug | Belrestotug will be administered. |
| BIOLOGICAL | Pembrolizumab | Pembrolizumab will be administered. |
| DRUG | Placebo | Placebo will be administered. |
Timeline
- Start date
- 2024-06-10
- Primary completion
- 2027-02-02
- Completion
- 2027-02-02
- First posted
- 2024-06-24
- Last updated
- 2025-09-10
Locations
134 sites across 21 countries: United States, Argentina, Belgium, Brazil, Bulgaria, Canada, China, Finland, France, Germany, Hong Kong, India, Japan, Mexico, Netherlands, Panama, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye)
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06472076. Inclusion in this directory is not an endorsement.