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IDRX-42 versus sunitinib for adults with advanced gastrointestinal stromal tumors after imatinib

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)

Phase 3 Interventional GlaxoSmithKline · NCT07218926

This test compares IDRX-42 (GSK6042981) with sunitinib in adults with advanced or unresectable GIST who have already been treated with imatinib to see which controls the cancer better and is safer.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment450 (estimated)
Ages18 Years and up
SexAll
SponsorGlaxoSmithKline Industry-sponsored
Drugs / interventionsimatinib, sunitinib
Locations84 sites (Phoenix, Arizona and 83 other locations)
Trial IDNCT07218926 on ClinicalTrials.gov

What this trial studies

This Phase 3, randomized interventional trial compares oral IDRX-42 (GSK6042981) to sunitinib in adults with metastatic or unresectable gastrointestinal stromal tumors (GIST) whose disease progressed on or who are intolerant to imatinib. Participants will be assigned to receive either IDRX-42 or sunitinib and will be followed for tumor response, progression-free survival, and safety outcomes. Tumor tissue (archival or new biopsy) will be submitted for central retrospective biomarker analysis to explore markers of response. Key exclusions include active untreated central nervous system metastases, prior severe hypersensitivity to the study drugs, and recent other progressing malignancies.

Who should consider this trial

Good fit: Adults with histologically or cytologically confirmed metastatic or unresectable GIST who have progressed on or are intolerant to first-line imatinib and can provide tumor tissue for biomarker analysis.

Not a fit: Patients with untreated or active brain metastases, a history of severe hypersensitivity to these drugs (including Stevens-Johnson syndrome), recent other progressing cancers, or who cannot attend the U.S. study sites are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, IDRX-42 could provide improved disease control or a better safety profile compared with sunitinib for patients whose GIST progressed after imatinib.

How similar studies have performed: Other tyrosine kinase inhibitors such as sunitinib have shown benefit as second-line therapy for GIST, but IDRX-42 is a new agent and has not yet been proven superior in head-to-head trials.

Eligibility criteria

Show full inclusion / exclusion 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.
* Tumor tissue must be available to be submitted to the central laboratory for retrospective biomarker analysis. The sample may be from archival tissue or a new biopsy. Tissue samples are not required to be submitted centrally prior to randomization.

Exclusion Criteria:

* 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.

Where this trial is running

Phoenix, Arizona and 83 other locations

+34 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Gastrointestinal NeoplasmsGSK6042981IDRX-42SunitinibImatinibGastrointestinal Stromal Tumors
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.