A Phase 2 Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Silevertinib, an Oral EGFR Inhibitor, in Combination With Temozolomide in Patients With Newly Diagnosed Glioblastoma With Unmethylated MGMT Promoter and EGFRvIII

NCT07326566 Phase 2 RECRUITING

The purpose of this study is to see if combining silevertinib with temozolomide after surgery and radiotherapy helps treat newly diagnosed glioblastoma (GBM) better than using temozolomide alone in the maintenance setting. Specifically, this study is being done to find answers to the following questions: * How much of the study drugs (silevertinib combined with temozolomide) should be given to participants with GBM? * What are the side effects participants have when taking the study drug (silevertinib combined with temozolomide)? * Can the study drug (silevertinib combined with temozolomide) help participants with GBM live longer without disease progression compared to treatment with temozolomide alone?

Details

Lead sponsor	Black Diamond Therapeutics, Inc.
Phase	Phase 2
Status	RECRUITING
Enrolment	162
Start date	2026-05-05
Completion	2029-03

Conditions

• Glioblastoma (GBM)
• Newly Diagnosed Glioblastoma
• GBM
• Glioblastoma Multiforme (GBM)
• Glioma
• Central Nervous System Diseases
• Brain Cancer

Interventions

• silevertinib in combination with temozolomide
• temozolomide (TMZ)

Primary outcomes

• Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) — 12 months
  Progression-free survival, defined as the time from the date of randomization to the date of first disease progression per RANO 2.0 by BICR assessment or death from any cause, whichever occurs first.

Countries

United States