A Study of IDRX-42 (GSK6042981) Versus (vs) Sunitinib in Participants With Gastrointestinal Stromal Tumors After Imatinib Therapy (StrateGIST 3)

A Study of IDRX-42 (GSK6042981) Versus (vs) Sunitinib in Participants With Gastrointestinal Stromal Tumors After Imatinib Therapy (StrateGIST 3)

Gastrointestinal Stromal Tumor

Recruiting

3

Start Date 12/03/2025

Age of Trial (yrs) .2

Gleevec-resistant

KIT/PDGFRA inhibitor

Block KIT/PDGFRA

Specifically GIST and only GIST

300383 2025-522229-37-00 ( EU Trial (CTIS) Number )

GlaxoSmithKline

US GSK Clinical Trials CallCenter 877-379-3718 GSKClinicalSupportHD@gsk.com EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Randomized

Oral

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.
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.