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] (NCT07218926)

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.

Trial phase

Phase 3

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Prof John Zalcberg

Key inclusion data

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 locally assessed mutation status of KIT and/or PDGFRA. Central testing on archival samples may be available, where a pathology report is not available or insufficient to assess mutation status prior randomization. ≥1 target lesions per mRECIST-GIST. Tumor tissue availability for retrospective biomarker analysis (see the Laboratory Manual for minimum requirements). The sample may be from archival tissue or a new biopsy.