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

Background: Glioblastoma (GBM) is notoriously difficult to treat, with current therapies often extending life by only a few months. The standard treatment involves surgery followed by radiation and chemotherapy with Temozolomide (TMZ). The efficacy of TMZ, however, is significantly enhanced when the tumor's o6-methylguanine-DNA-methyltransferase (MGMT) gene is methylated. Recent studies, such as the NOA-09 trial, have suggested that adding Lomustine (LOM) to TMZ could improve outcomes for patients with this specific tumor profile. Hypothesis: The investigators hypothesize that the addition of LOM to the TMZ regimen will lead to significantly improved survival rates among patients with newly diagnosed glioblastoma who have a methylated MGMT promoter compared to those receiving only TMZ. Treatment Plans: The study will randomly assign participants to two groups: * Control Group: Standard treatment with TMZ during and after radiation therapy. * Experimental Group: TMZ combined with LOM, starting on the first day of radiation therapy. Outcome Measures: The primary outcome measure will be survival. Other outcomes will include progression-free survival (time from randomization until tumor progression or death), safety profiles (adverse effects of the treatments), and quality of life measures as well as neurocognitive outcomes.

NCT Number	NCT06419946
Lead Sponsor	Vastra Gotaland Region Collaborators: Skane University Hospital, Gävle Hospital, Karolinska Institutet, Sahlgrenska University Hospital, Ryhov County Hospital, Kalmar County Hospital, Oslo University Hospital, St. Olavs Hospital, Haukeland University Hospital, Sorlandet Hospital HF, Helse Stavanger HF, Aarhus University Hospital, Region Örebro County, University Hospital, Umeå, Uppsala University Hospital, Universitäts-Frauenklinik Graz, University Hospital of Sankt Pölten, Sundsvalls Hospital, Kepler University Hospital, medizinische universität innsbruck, Austria
Conditions	Glioblastoma, IDH-wildtype, MGMT-Methylated Glioblastoma
Enrollment	200 participants
Start Date	2025-02-01
Primary Completion	2031-12-15 (estimated)
Study Completion	2033-12-15 (estimated)
Updated on ClinicalTrials.gov	2026-04-13