Not Yet RecruitingPhase 3

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

800 participantsStarted 2026-06-15

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

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Inclusion criteria

. Those of non-childbearing potential are eligible without additional contraception.
. Those of childbearing potential must use an acceptable, highly effective contraceptive method and have a negative pregnancy test before starting the study. The investigator will assess their pregnancy risk.

Exclusion criteria

. Has documented evidence of plasma HIV-1 ribonucleic acid (RNA) ≥50 c/mL within 3 months prior to or at screening. In the 3 to 12 months prior to screening, plasma HIV 1 RNA levels consistently \<50 c/mL are required for enrollment; if multiple instances of plasma HIV-1 RNA values ≥50 c/mL occurred in the 3 to 12 months prior to screening, the participant is not eligible for enrollment unless, per the investigator's assessment, the elevations were neither persistent nor associated with antiretroviral resistance; OR
. Has not had CD4 cell counts measured in the past 12 months (i.e., at least two separate measurements taken a minimum of 28 days apart, one of which must be conducted at screening); OR

What they're measuring

Progression-Free Survival (PFS) as assessed by Blinded independent central review (BICR)

Timeframe: Up to approximately 74 months

Trial details

NCT IDNCT07585266

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2032-08-30

Contact for this trial

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

View on ClinicalTrials.gov More Gastrointestinal Stromal Neoplasms trials