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

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

Gastrointestinal Stromal Tumor

Not yet recruiting

3

Start Date 06/15/2026

Age of Trial (yrs) 0

First-line

KIT/PDGFRA inhibitor

Block KIT/PDGFRA

Specifically GIST and only GIST

306293 2025-524934-24

GlaxoSmith Kline

US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com EU GSK Clinical Trials Call Cente+44 (0) 20 89904466l: GSKClinicalSupportHD@gsk.com

Randomized

Oral

Brief 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 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.


Partial Eligibility Criteria (Follow NCT Number Link for full criteria)

Inclusion Criteria:

Is at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the Informed consent form (ICF).
Has histologically or cytologically confirmed GIST that is metastatic and/or surgically unresectable.
Has not received prior systemic therapy for their metastatic and/or surgically unresectable GIST.
Tumor tissue must be provided to the central laboratory. Tumor tissues may be archival (preferred) or obtained from a fresh biopsy acquired for standard of care (biopsies must be collected before randomization).
Participants must have ≥1 target lesion (TL).