Belrestotug+dostarlimab phase 3 in untreated PD_L1 high NSCLC patients
Research type
Research Study
Full title
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)
IRAS ID
1010057
Contact name
Contact email
Sponsor organisation
GSK Research & Development Limited
Eudract number
2023-504753-12
Research summary
Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. Common symptoms include cough that does not go away, chest pain, and tiredness. Some cancer cells have a type of protein called programmed cell death ligand 1 (PD-L1) on their surface. Current treatment options include chemotherapy and medicines that block PD-L1 protein. Some people may respond to treatment while some do not. Of those who respond, the cancer may come back after being treated.
This study will assess the safety and effectiveness of dostarlimab plus belrestotug compared with pembrolizumab plus placebo (salt solution without any active medicine). The study will enrol participants who have not received any prior treatment for their advanced NSCLC, and whose cancer has high levels of PD-L1 protein.
The main objective of this study is To check how well dostarlimab plus belrestotug works in participants with NSCLC whose PD-L1 levels are high when compared with pembrolizumab plus placebo.
Men and women will be included in this study if they:
• are 18 years of age or above.
• are diagnosed with NSCLC and have high levels of PD-L1 protein.
• have not received any prior treatment for their advanced NSCLC.
Men and women will not be included in this study if they:
• have NSCLC with a tumour that has genetic changes against which other treatment is available.
• have had surgery within 4 weeks of the first dose of the study treatment.
• have received prior treatments for their advanced NSCLC.
• Participants will be randomly assigned to receive dostarlimab plus belrestotug or pembrolizumab plus placebo as an infusion into a vein.
A total of approximately 1000 participants will be randomized by private and public sites across the dostarlimab plus belrestotug and pembrolizumab plus placebo arms in a 1:1 ratio, 6 participants in the UK.
Patients should remain on treatment until they benefit from treatment according to Investigator and sponsor.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
24/NW/0319
Date of REC Opinion
3 Dec 2024
REC opinion
Further Information Favourable Opinion