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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)
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
GSK Investigational Site
Ocala, Florida, United States
GSK Investigational Site
Honolulu, Hawaii, United States
GSK Investigational Site
Lexington, Kentucky, United States
GSK Investigational Site
Lexington, Kentucky, United States
GSK Investigational Site
Ann Arbor, Michigan, United States
GSK Investigational Site
Omaha, Nebraska, United States
GSK Investigational Site
Nashville, Tennessee, United States
GSK Investigational Site
Fort Worth, Texas, United States
GSK Investigational Site
Olympia, Washington, United States
GSK Investigational Site
Buenos Aires, Argentina
Start Date
June 10, 2024
Primary Completion Date
February 2, 2027
Completion Date
February 2, 2027
Last Updated
September 10, 2025
88
ACTUAL participants
Dostarlimab
BIOLOGICAL
Belrestotug
BIOLOGICAL
Pembrolizumab
BIOLOGICAL
Placebo
DRUG
Lead Sponsor
GlaxoSmithKline
Collaborators
NCT07219251
NCT06405230
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04940936