NCT06419946 Lomustine in Addition to Standard of Care in Patients With MGMT Methylated Glioblastoma
| NCT ID | NCT06419946 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Vastra Gotaland Region |
| Condition | Glioblastoma, IDH-wildtype |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2031-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 200 participants in total. It began in 2025-02-01 with a primary completion date of 2031-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Newly diagnosed glioblastoma/gliosarcoma, IDH wild type * Methylated MGMT promoter * World Health Organization performance status 0-2 * Age 18-70 Exclusion Criteria: * Previous malignancy within 3 y or malignancy treated non-curatively * Previous chemotherapy or radiotherapy involving the head * Off-protocol tumor-specific treatment * Serious comorbidity
Contact & Investigator
Annika Malmström, MD, PhD
PRINCIPAL INVESTIGATOR
University Hospital, Linkoeping
Frequently Asked Questions
Who can join the NCT06419946 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Glioblastoma, IDH-wildtype. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06419946 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 200 participants.
Is NCT06419946 currently recruiting?
Yes, NCT06419946 is actively recruiting participants. Contact the research team at asgeir.jakola@vgregion.se for enrollment information.
Where is the NCT06419946 trial being conducted?
This trial is being conducted at Graz, Austria, Innsbruck, Austria, Linz, Austria, Sankt Pölten, Austria and 11 additional locations.
Who is sponsoring the NCT06419946 clinical trial?
NCT06419946 is sponsored by Vastra Gotaland Region. The principal investigator is Annika Malmström, MD, PhD at University Hospital, Linkoeping. The trial plans to enroll 200 participants.
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