December 09 2021
NRG-BN011: A Phase III Trial of Lomustine-Temozolomide Combination Therapy Versus Standard Temozolomide in Patients with MEthlyated MGMT Promoter Glioblastoma
Currently, the standard of care treatment for patients with a glioblastoma (GBM) is radiation and temozolomide (TMZ) chemotherapy due to previous evidence that TMZ improved median overall survival for this patient population by over two months; from 12.1 months with radiotherapy alone to 14.6 months with the addition of TMZ. MGMT promoter methylation is as a strong predictor of survival benefit from alkylating therapy, such as TMZ, in GBM patients. Since this standard was established in 2005, numerous trials have made attempts to further improve overall survival for patients, however, all trials other than the addition of tumor treating fields (TTFields) failed to show benefit. A few trials tested the combination of two alkylators, TMZ and lomustine, in patients with glioblastomas and suggested a survival benefit, but these studies were small.
“NRG-BN011 was created to assess the combination of temozolomide and lomustine in a fully-powered, phase 3 trial design,” stated Fabio Iwamoto, MD, of the Columbia University Irving Medical Center and the Principal Investigator of the NRG-BN011 study. “If successful, the NRG-BN011 trial will establish a new standard of care in a patient population with high unmeet need, that urgently needs more treatment options to improve survival rates.”
NRG-BN011 is enrolling patients with confirmed GBM and methylated MGMT promoter status stratified by recursive partitioning analysis and the intent to use TTFields (Optune). Eligible patients will then be randomly assigned to receive radiation therapy with concomitant and adjuvant TMZ (Treatment Arm 1), or to received radiation therapy with concomitant and adjuvant lomustine and TMZ.
The primary goal of NRG-BN011 is to determine if the addition of lomustine to standard radiotherapy and temozolomide prolongs overall survival for patients with GBM compared to the standard of care. The trial will also aim to determine if the added TMZ and lomustine prolongs progression-free survival for trial participants, and will compare patient-reported outcomes and toxicity between the treatment groups.
Learn more about this trial on ClinicalTrials.gov
Protocol documents and materials are located on the CTSU website.