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)
To compare the efficacy of IDRX-42 (GSK6042981) to that of sunitinib in participants with metastatic and/or unresectable GIST after failure of imatinib therapy, as evidenced by PFS. To compare the efficacy of IDRX-42 (GSK6042981) to that of sunitinib.
Why this Research Matters
This is a Phase 3, randomized, open-label, comparative, global multicenter study in which participants with metastatic and/or unresectable GIST who have progressed on or were intolerant to first-line therapy with imatinib will be randomized in a 1:1 fashion to receive IDRX-42 (GSK6042981) (Arm A) or sunitinib (Arm B)
Who can Participate
Inclusion: -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 must be available for participant stratification, using a tissue-based next-generation sequencing or PCR assay. Exclusion: -GIST that is known to be both KIT and PDGFRA wild-type or known to harbor an activating PDGFRA exon 18 mutation. -Known untreated or active central nervous system metastases. More details about who can and cannot join are on ClinicalTrials.gov. Your study doctor or study team member will review these requirements with you.
Study ID
Protocol Number: 25-2548
More information available at ClinicalTrials.gov: NCT07218926
Meet the Team
Principal Investigator