A Phase 3 study of velzatinib vs imatinib in participants with metastatic and/or unresectable GIST
Research type
Research Study
Full title
A Phase 3, Randomized, Multicenter, Open-Label Study of Velzatinib (GSK6042981) versus Imatinib in Participants with Previously Untreated Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST)
IRAS ID
1013762
Contact name
N/A N/A
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Ltd
Eudract number
2025-524934-24
Clinicaltrials.gov Identifier
Research summary
Gastrointestinal Stromal Tumour (GIST) is a soft tissue tumour that develops in the digestive system, most often in the stomach or small intestine. It is caused by changes in proteins that lead the cells to grow uncontrollably. Although current treatments may be effective, tumours may stop responding over time, highlighting the need for new options. This study is evaluating velzatinib (GSK6042981) in participants with newly diagnosed GIST that has spread or cannot be surgically removed. Velzatinib will be compared with imatinib, the standard treatment, to assess whether it can delay disease worsening and is safe and well tolerated.
The main objective of the trial is to see how well velzatinib works compared with imatinib in people who have not been treated before for GIST that has spread or cannot be removed by surgery.
The secondary objectives of the study are to further study how well velzatinib works compared with imatinib in people who have not been treated before for GIST that has spread or cannot be removed by surgery, and to study the long-term effects of velzatinib compared with imatinib in people who have not been treated before for GIST that has spread or cannot be removed by surgery.
This is an open-label study, meaning both the researchers and participants will know which treatment is being given. Participants will be randomly assigned to different treatment groups. This is called randomisation and is done purely by chance, like flipping a coin. Participants will be divided into two groups: Group 1 will receive the study medicine, velzatinib, while Group 2 will receive imatinib.
An Independent Data Monitoring Committee will review the study data to ensure participant safety. This study will be conducted in agreement with the protocol and will follow international ethical guidelines. Participants will be monitored closely for any potential side effects throughout the study.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
26/SC/0133
Date of REC Opinion
8 Jul 2026
REC opinion
Further Information Favourable Opinion