A Study to Investigate Velzatinib Compared With Imatinib in Adult Participants With Previously Untreated Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (StrateGIST Frontline) (NCT07585266)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: GSK Investigational Site — Omaha, Nebraska
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (17 Sites)
- GSK Investigational Site — Omaha, Nebraska
- GSK Investigational Site — Canton, Ohio
- GSK Investigational Site — Knoxville, Tennessee
- GSK Investigational Site — Buenos Aires,
- GSK Investigational Site — Ciudad Autonoma de Buenos Aire,
- GSK Investigational Site — Toronto, Ontario
- GSK Investigational Site — Beijing,
- GSK Investigational Site — Fukuoka,
- GSK Investigational Site — Hokkaido,
- GSK Investigational Site — Kanagawa,
- GSK Investigational Site — Toyama,
- GSK Investigational Site — Seoul, Seoul Teugbyeolsi
- GSK Investigational Site — Seoul,
- GSK Investigational Site — Seoul,
- GSK Investigational Site — Seoul,
- GSK Investigational Site — Changhua,
- GSK Investigational Site — Taichung,
📞 Contact the Study Coordinator
Phone: (877) 379-3718
Email: GSKClinicalSupportHD@gsk.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Gastrointestinal Stromal Neoplasms clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.