Phase 3 Study of IDRX-42 vs Sunitinib in Participants with Metastatic and/or Unresectable GIST
Research type
Research Study
Full title
A Phase 3, Randomized, Multicenter, Open-Label Study of IDRX-42 (GSK6042981) versus Sunitinib in Participants with Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST) after Imatinib Therapy (StrateGIST 3)
IRAS ID
1012652
Contact name
N/A N/A
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Ltd
Eudract number
2025-522229-37
Research summary
Gastrointestinal Stromal Tumour (GIST) is a rare type of cancer that forms in the digestive tract, most often in the stomach or small intestine. In some cases, the tumor is found early and can be removed with surgery. But in many people, the cancer has already spread or returns later and needs to be treated with medicines. However, current treatments don’t work for everyone or may stop working overtime. This means new treatment options are needed for people whose cancer no longer responds to available medicines.
This study aims to find out if a new medicine called IDRX-42 (known as GSK6042981) works better and is safer than the current treatment, sunitinib, in people with GIST. These participants have already tried another medicine, imatinib, but it either did not work or caused side effects.
The main objective of the study is to assess if GSK6042981 works better than sunitinib in participants with advanced GIST, that has spread or cannot be removed with surgery after imatinib treatment has stopped working. The key secondary objective of the study is to compare how well GSK6042981 works compared to sunitinib.
The Primary (main) endpoint of the study is to measure how long the cancer stays under control without getting worse, this is called progression-free survival (PFS). PFS is the time from when a participant joins the study to when their cancer gets worse or they pass away, whichever happens first. This will be assessed using scan results. The key secondary endpoint is measure overall survival (OS), which is the time from when a participant joins the study to when they pass away from any cause.
This is an open-label study, which means that both the participants and the researchers will know which treatment is being given. Participants will be randomly assigned to one of two groups. This process is called randomisation.
• One group will receive the new medicine, GSK6042981.
• The other group will receive the current standard treatment, sunitinib.REC name
South Central - Berkshire Research Ethics Committee
REC reference
25/SC/0266
Date of REC Opinion
20 Nov 2025
REC opinion
Further Information Favourable Opinion