A Phase III Trial of Lomustine-Temozolomide Combination Therapy Versus Standard Temozolomide in Patients with Methylated MGMT Promoter Glioblastoma (NRG-BN011)

This study is being done discover if adding the chemotherapy drug lomustine (Gleostine) to usual treatment will extend life and prolong tumor return or inhibit growth.

This trial will help determine if this approach is better, the same, or worse than the usual approach for brain tumors. The usual approach is defined as care most people get for glioblastoma brain tumors.

The usual approach for patients who are not in a study is surgery followed by treatment with radiation and a Food and Drug Administration (FDA)-approved drug called temozolomide, followed by temozolomide alone. Some patients also use an FDA-approved device called Optune to accompany the usual treatment. Optune is a portable device that uses electrodes applied to a patient’s head to send electric signals that could slow or stop cancer cell growth.

This study has public funding from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH) in the United States Department of Health and Human Services.

Inova Schar Cancer Institute
A department of Inova Fairfax Hospital
8081 Innovation Park Dr.
Fairfax, VA 22031

• Male or female ages 18-70 years
• Histopathologically proven diagnosis of glioblastoma (or gliosarcoma as a subtype of glioblastoma) confirmed by central pathology review
• MGMT promoter with methylation confirmed by central pathology review
• Additional eligibility in protocol

• Pregnancy/Breastfeeding
• IDH mutation
• Prior therapy for tumor except for resection
• Definitive clinical or radiologic evidence of metastatic disease outside the brain
• For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
• For patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
• Known human immunodeficiency virus (HIV) infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to step 2 registration are eligible for this trial
• Additional ineligibility in protocol

For additional information, please go to: https://clinicaltrials.gov/ct2/show/NCT05095376