A Study to Investigate Velzatinib Compared With Imatinib in Adult Participants With Previously Untreated Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (StrateGIST Frontline)

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 certain proteins that cause the cells to grow uncontrollably. Although current treatments may be effective, tumours may stop responding over time, highlighting the need for newer 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.

NCT Number	NCT07585266
Lead Sponsor	GlaxoSmithKline
Conditions	Gastrointestinal Stromal Neoplasms
Enrollment	800 participants
Start Date	2026-07-10
Primary Completion	2032-09-06 (estimated)
Study Completion	2032-10-05 (estimated)
Updated on ClinicalTrials.gov	2026-07-07