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

Conditions

• Gastrointestinal Stromal Neoplasms

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Velzatinib — DRUG
  Velzatinib will be administered
• Imatinib — DRUG
  Imatinib will be administered

Study Details

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.

Key Dates

First listed

May 13, 2026

Start date

Jul 27, 2026

Status verified

Aug 2026

Primary completion

Aug 30, 2032

Completion

Sep 28, 2032

Study Design

Enrollment

800 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Velzatinib
• Experimental: Imatinib

Primary Outcome Measure

Progression-Free Survival (PFS) as assessed by Blinded independent central review (BICR) [ Time Frame: Up to approximately 74 months ]

Central Contacts

• US GSK Clinical Trials Call Center
  877-379-3718
  [email protected]
• EU GSK Clinical Trials Call Center
  +44 (0) 20 89904466
  [email protected]

Locations (3)

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