NRG-BN011 is a clinical study for people with a type of brain tumor called a glioblastoma that have not yet received treatment other than surgery for their disease. Participants in this trial will need to be tested to see if their tumor has a biomarker called “methylated” MGMT. A biomarker gives information about how the tumor may respond to treatment. The MGMT methylation test helps predict if the tumor will respond to temozolomide, the standard chemotherapy drug used for glioblastomas. MGMT methylated tumors are more likely to respond to temozolomide chemotherapy.
NRG-BN011 will test to see if the addition of a second chemotherapy drug called lomustine to the usual treatment of radiation and temozolomide chemotherapy can help extend your life or stabilize your cancer. Lomustine is currently approved by the Food and Drug Administration (FDA)- to treat brain tumors, however, it is usually used for recurrent tumors. Researchers are doing this study to find out if this approach is better, the same, or worse than the usual approach for your brain tumor.