Phase III Trial Comparing Temozolomide Plus Lomustine Versus Standard Temozolomide Therapy for Newly Diagnosed MGMT Methylated Glioblastoma Patients with or without Tumor Treating Fields

What this Trial Is About

Researchers are evaluating a treatment approach for patients with newly diagnosed glioblastoma that have a methylated MGMT promoter, a specific genetic feature of the tumor. This phase 3 clinical trial compares the standard chemotherapy drug Temozolomide (TMZ) alone to a combination of Temozolomide plus Lomustine (LOM). The study aims to determine if adding Lomustine improves survival rates, progression-free survival, safety, quality of life, and cognitive function. Participants are randomly assigned to one of two groups. The control group receives Temozolomide during and after radiation therapy. The experimental group receives both Temozolomide and Lomustine starting on the first day of radiation. Lomustine and Temozolomide are given as oral pills in cycles, with Lomustine cycles lasting 42 days for a total of six cycles over about nine months, while Temozolomide cycles last 28 days with six cycles over about 8.5 months. Radiation therapy is given concurrently with the start of chemotherapy in both groups. During the study, participants will have regular assessments including survival monitoring, tumor progression checks, and safety evaluations for side effects. Quality of life and detailed neurocognitive tests measuring memory, attention, motor skills, and reaction times are conducted at the start, end of radiotherapy, and every 24 weeks for up to 36 months. Adverse events are tracked from randomization until death or three years of follow-up. The study involves close monitoring to understand the long-term effects and benefits of adding Lomustine to standard treatment.

Lomustine in Addition to Standard of Care in Patients With MGMT Methylated Glioblastoma