StrateGIST?3 is an international, multicenter, randomized, open-label Phase?III trial comparing IDRX-42 (GSK6042981) with sunitinib in adults with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) following imatinib therapy. The primary endpoint is progression-free survival (PFS). Secondary endpoints include overall survival (OS), objective response rate (ORR), time to confirmed deterioration (TTCD), quality of life (EORTC?QLQ-C30), and safety measures such as TEAEs and SAEs. Eligible participants must have histologically or cytologically confirmed GIST with documented progression or intolerance to imatinib. Randomization assigns participants to receive either IDRX-42 or sunitinib in an open-label design.
This international clinical study tests whether a new medicine called IDRX-42 works safely and effectively for people with gastrointestinal stromal tumors (GIST), a type of cancer of the digestive system. The trial includes adults whose disease has worsened after treatment with imatinib or cannot be surgically removed. Participants are randomly assigned to receive either IDRX-42 or the approved drug sunitinib. The main goal is to find out how long the cancer can be kept from getting worse. Researchers will also monitor quality of life, overall survival, and treatment side effects.
