Phase 3 Study Comparing IDRX-42 GSK6042981 and Sunitinib for Adults With Advanced or Unremovable Gastrointestinal Stromal Tumors After Imatinib Treatment

What this Trial Is About

Researchers are evaluating a new drug called IDRX-42 GSK6042981 for adults with metastatic or unresectable Gastrointestinal Stromal Tumors GIST who have previously been treated with imatinib. The study compares IDRX-42 to another drug, sunitinib, to see which is more effective and safe. Participants whose disease worsens after sunitinib treatment may switch to IDRX-42 if they meet certain criteria. Participants will be randomly assigned to receive either IDRX-42 or sunitinib. The treatments will be administered according to study protocols, and the study is open-label, meaning both participants and researchers know which treatment is given. The study includes a crossover option allowing some participants to switch to IDRX-42 if their disease progresses while taking sunitinib. During the study, participants will be monitored for progression-free survival over approximately 130 weeks and overall survival up to about 261 weeks. Researchers will also evaluate tumor response, quality of life, and treatment safety through various assessments including patient-reported outcomes and adverse event tracking. The total study duration may extend up to five years, with regular visits and evaluations throughout.

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