NCT07218926From ClinicalTrials.govRecruiting

A Study of IDRX-42 (GSK6042981) Versus (vs) Sunitinib in Participants With Gastrointestinal Stromal Tumors After Imatinib Therapy

A Phase 3, Randomized, Multicenter, Open-Label Study of IDRX-42 (GSK6042981) Versus Sunitinib in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST) After Imatinib Therapy (StrateGIST 3)

Gastrointestinal Neoplasms

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: GlaxoSmithKline
Enrolment target: 450
Started: 3 December 2025
Main results due: 30 May 2028
Study sites: 155
Registry updated: 25 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

Inclusion Criteria:

* Participants with histologically or cytologically confirmed GIST that is metastatic and/or surgically unresectable.
* Documented disease progression on or intolerance to imatinib administered for first-line treatment of unresectable/metastatic disease.
* Documented mutation status of KIT and/or PDGFRA using a tissue based next-generation sequencing or polymerase chain reaction (PCR) assay.
* Tumor tissue must be available for retrospective biomarker analysis. Sample may be archival or new biopsy.

Exclusion Criteria:

* GIST that is both KIT and PDGFRA wild-type or known to harbor an activating PDGFRA exon 18 mutation.
* Known untreated or active central nervous system metastases.
* Participants with a known allergy or hypersensitivity to any component of IDRX-42 (GSK6042981) or sunitinib. Participants with a history of Stevens-Johnson syndrome on a prior Tyrosine kinase inhibitor (TKI) are excluded.
* Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas (e.g., breast, cervix, bladder) that have been resected with no evidence of metastatic disease.

What this study is about

In the sponsor’s own words, from the registry.

The purpose of this study is to find out if a new drug, called IDRX-42 (also known as GSK6042981), is effective in treating adults with a type of cancer called Gastrointestinal Stromal Tumors (GIST) when compared to another drug named sunitinib. The study will see if IDRX-42 works well and is safe for participants whose GIST has spread or cannot be surgically removed, and who have already taken the drug imatinib. Participants whose disease worsens after receiving sunitinib in this study may cross over to receive GSK6042981, at investigator's discretion and if additional eligibility criteria are met.

Study sites(155)

GSK Investigational Site
Phoenix, Arizona, United States
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GSK Investigational Site
Duarte, California, United States
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GSK Investigational Site
La Jolla, California, United States
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Los Angeles, California, United States
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San Francisco, California, United States
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Santa Monica, California, United States
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Upland, California, United States
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Aurora, Colorado, United States
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New Haven, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Tampa, Florida, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Iowa City, Iowa, United States
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Overland Park, Kansas, United States
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Baton Rouge, Louisiana, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Rochester, Minnesota, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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New Hyde Park, New York, United States
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New York, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Canton, Ohio, United States
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Columbus, Ohio, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Spartanburg, South Carolina, United States
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Knoxville, Tennessee, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Salt Lake City, Utah, United States
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Charlottesville, Virginia, United States
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Fairfax, Virginia, United States
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Seattle, Washington, United States
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Tacoma, Washington, United States
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Milwaukee, Wisconsin, United States
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Garran, Australian Capital Territory, Australia
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Camperdown, New South Wales, Australia
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Westmead, New South Wales, Australia
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Melbourne, Victoria, Australia
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Leuven, Belgium
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Barretos, São Paulo, Brazil
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São Caetano do Sul, São Paulo, Brazil
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Porto Alegre, Brazil
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GSK Investigational Site
Recife, Brazil
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GSK Investigational Site
Vitória, Brazil
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GSK Investigational Site
Calgary, Alberta, Canada
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GSK Investigational Site
Toronto, Ontario, Canada
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Showing 60 of 155 sites — filter to narrow it down. 155 of the 155 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07218926. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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