Clinical Trials

Inclusion Criteria:

• Participants ≥ 18 years, unless country specific standards require a different age for minors (e.g. ≥ 19 years in Korea).
• 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.
• Locally assessed mutation status of KIT/PDGFRA must be available for patient stratification, using a tissue-based next-generation sequencing (NGS) or PCR assay. A molecular pathology report with mutation status of KIT/PDGFRA must be provided to the Sponsor for review prior to randomization. Sample may have been obtained at any time point from initial GIST diagnosis or later. If a molecular pathology report is not available or is insufficient, an archival tumor tissue sample is required for confirmation of mutation status by the central laboratory prior to randomization.
• ≥ 1 measurable lesion by mRECIST v1.1.
• Eastern Cooperative Oncology Group performance status ≤ 2.
• All toxicities from prior therapy have resolved to Grade ≤ 1 according to NCI CTCAE v5.0 or have resolved to baseline severity for the participant at the time of randomization. Note: Treatment-related Grade > 1 alopecia, treatment-related Grade 2 peripheral neuropathy, and treatment-related Grade 2 hypothyroidism on a stable dose of thyroid hormone replacement therapy are allowed if deemed irreversible.

Exclusion Criteria:

• Any prior treatment with systemic anticancer therapy for GIST other than imatinib.
• GIST that is known to be both KIT and PDGFRA wild-type or known to harbor a PDGFRA exon 18 mutation.
• Has known untreated or active central nervous system metastases.
• Has significant, uncontrolled, or active cardiovascular disease.
• Has an active uncontrolled infection, including, but not limited to, the requirement for intravenous antibiotics.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 12/30/2024. Questions regarding updates should be directed to the study team contact.