Pairing Silevertinib and Temozolomide to Treat Newly Diagnosed Glioblastoma

Recruiting · Phase 2 · Glioblastoma (GBM) and related conditions · 9 states

Check if I qualify View on ClinicalTrials.gov

About this trial

This study looks at whether the combination of silevertinib and temozolomide can help treat patients with newly diagnosed glioblastoma better than temozolomide alone. Glioblastoma is a type of brain cancer. The goal is to see if this combination can help patients live longer without their cancer getting worse. Researchers will also check for any side effects from the treatment.

The trial's ID number is NCT07326566. It is a Phase 2 study, which means it is looking at how well the treatment works and how safe it is. The study is regulated by the FDA and aims to include around 162 participants.

Who can join

Adults aged 18 and older can join. This study is for people with newly diagnosed glioblastoma who have had surgery and radiation therapy. Participants must not have received any other treatments for their cancer. The trial team will make sure each person is eligible to join.

Conditions

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

Age group

Adult, Older adult

Sex

All sexes

The study team makes the final call on eligibility.

What happens in the study

Participants will be divided into two groups by chance: one group will receive both silevertinib and temozolomide, while the other group will receive only temozolomide. Everyone will take the medications by mouth in cycles of 28 days. The silevertinib will be taken daily until the cancer progresses, and temozolomide will be taken for the first five days of each cycle for up to six cycles. Participants will have regular check-ups and tests throughout the study.