NRG-BN011

This phase III trial compares the effect of adding lomustine to standard chemotherapy with temozolomide and radiation therapy versus temozolomide and radiation therapy alone in shrinking or stabilizing newly diagnosed MGMT methylated glioblastoma. MGMT methylated tumors are more likely to respond to temozolomide chemotherapy. Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill tumor cells and slow down or stop tumor growth. Lomustine is a chemotherapy drug and in a class of medications called alkylating agents. It damages the cell's DNA and may kill tumor cells. Radiation therapy uses high energy x-ray photons to kill tumor cells and shrink tumors. Adding lomustine to standard chemotherapy with temozolomide and radiation therapy may shrink or stabilize glioblastoma.

In order to participate you must meet the following criteria:

• Have glioblastoma (or gliosarcoma) and the tumor must be IDH-wildtype (no IDH mutation) based on testing.
• Have a tumor that has MGMT promoter methylation confirmed by the central lab review.
• Have had tumor surgery (not biopsy only), and there must be enough tumor tissue to send for central testing within 30 days after surgery.
• Are 18–70 years of age.
• Are doing fairly well day-to-day (KPS ≥ 70).
• Have had a recent brain MRI.
• Have had acceptable blood/organ tests (and a negative pregnancy test if you could become pregnant), with birth control during treatment and for 6 months after.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.