A Phase 3 study to investigate velzatinib [IDRX-42] compared with imatinib in adult participants with previously untreated metastatic and/or unresectable gastrointestinal stromal tumors [GIST] (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. Participants whose disease worsens after receiving sunitinib in this study may cross over to receive GSK6042981, at investigator's discretion and if additional eligibility criteria are met.

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. No prior systemic therapy for metastatic and/or surgically unresectable GIST. Mutation status of KIT and/or PDGFRA must be available, using a tissue-based next-generation sequencing (NGS) assay. At least one target lesion per mRECIST-GIST. Must not have other malignancy that has progressed or required active treatment in the past 24 months.