OncoMatch/Clinical Trials/NCT05904119
Lomustine With and Without Reirradiation for First Progression of Glioblastoma: a Randomized Phase III Study
Is NCT05904119 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Lomustine for first progression of glioblastoma.
Treatment: Lomustine — Despite comprehensive multimodal treatment of newly diagnosed glioblastoma, almost all patients suffer from tumour relapse. Currently, no standard of care exists to treat these tumour relapses. Treatment options include repeated surgery (if feasible), systemic therapy (bevacizumab, lomustine, temozolomide re-challenge), reirradiation and best supportive care. Currently, the superiority of combined chemoradiation versus chemotherapy alone remains unproven. Given that lomustine is the standard chemotherapeutic agent for the treatment of recurrent glioblastoma in Europe and the unclear efficacy of reirradiation, we want to explore whether combining lomustine and reirradiation may be a better treatment than lomustine alone. The results of the prospective randomized trial proposed here should demonstrate a significant improvement in overall survival when lomustine is combined with reirradiation in patients with recurrent glioblastoma compared to lomustine alone without adversely affecting quality of survival. The trial will be stopped based on overall survival in a preplanned futility and efficacy interim analysis.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: IDH1 wild-type
IDH wildtype per WHO 2021 classification and local assessment of tissue from diagnosis or recurrence
Performance status
WHO 0–2
Prior therapy
Must have received: chemoradiotherapy — newly diagnosed
Patients with first progression or recurrent glioblastoma after standard chemoradiotherapy (any treatment other than use of nitroureas) having occurred at least 6 months after the end of prior radiotherapy
Must have received: temozolomide (temozolomide) — maintenance (optional)
chemoradiotherapy with or without maintenance chemotherapy with temozolomide (patient must have received at least one dose)
Must have received: surgery — newly diagnosed
Initial treatment of newly diagnosed glioblastoma by maximal safe resection
Cannot have received: anticancer treatment for recurrent glioblastoma
Exception: surgery
Any prior anticancer treatment for recurrent glioblastoma (except surgery)
Cannot have received: nitrosoureas
any treatment other than use of nitroureas
Lab requirements
Blood counts
significant reduction in thrombocyte and/or leukocyte counts [excluded]
Kidney function
severe renal impairment according to investigator's opinion [excluded]
Significant reduction in thrombocyte and/or leukocyte counts as well as severe renal impairment according to investigator's opinion
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify