NRG-BN011

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

Principal Investigator

Fabio Iwamoto, MD

Status

Disease Site

Brain [BN] Malignant Glioma

Phase

III

Developmental Therapeutics

No

Primary Objective

To determine if the regimen with the two alkylating agents temozolomide and lomustine with radiotherapy (RT) significantly prolongs overall survival (OS) vs. standard chemoradiotherapy with temozolomide in patients with newly diagnosed GBM (GBM) with MGMT promoter methylation.

Patient Population

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.  IDH mutation testing by at
least one method must be performed as part of standard of care and no
mutation must be found.

 

Target Accrual

306