GSK GALAXIES LUNG-301 PD-L1
Research type
Research Study
Full title
Clinical Performance Study Protocol for Use of VENTANA PD-L1(SP263) CDx Assay in GSK Study 213823 (GALAXIES LUNG-301)
IRAS ID
344310
Contact name
Manish Subramaniam
Contact email
Sponsor organisation
Ventana Medical Systems
Clinicaltrials.gov Identifier
2023-504753-12-00, GSK4428859A (belrestotug), GSK4057190 (dostarlimab); 213823, GSK4428859A (belrestotug), GSK4057190 (dostarlimab)
Duration of Study in the UK
2 years, 5 months, 29 days
Research summary
The objective of this study is to see how in a clinical trial the VENTANA Programmed Death Ligand 1 (PD-L1)* Assay works to identify patients with Non-Small Cell Lung Cancer (NSCLC) who may benefit from taking the drug dostarlimab in combination with another drug, belrestotug. This clinical performance study is being conducted with the GALAXIES LUNG-301 Study to measure the amount of PD-L1 in tumor samples submitted for the GALAXIES LUNG-301 Study.
PD-L1 expression level will be used to choose patients who qualify, place them in the study, and analyze results in the GALAXIES LUNG-301 Study. Results from the GALAXIES LUNG-301 study may be used to establish how well the VENTANA PD-L1
Assay performs.*PD-L1 is a protein in your immune system.
REC name
North of Scotland Research Ethics Committee 1
REC reference
24/NS/0093
Date of REC Opinion
16 Sep 2024
REC opinion
Further Information Favourable Opinion