Adding lomustine to standard care for MGMT‑methylated glioblastoma
Official title: Phase III Trial of Temozolomide/Lomustine (TMZ/LOM) Combination Therapy vs. Standard TMZ Therapy for Newly Diagnosed MGMT Promoter Methylated Glioblastoma (IDHwt) Patients +/- Tumor Treating Fields (Optune)
Run by Vastra Gotaland Region · NCT06419946 · Data updated 2026-11-12
This trial tests whether giving lomustine together with temozolomide and radiation helps adults with newly diagnosed, MGMT‑methylated, IDH‑wildtype glioblastoma live longer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Vastra Gotaland Region Government |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 20 sites (Graz and 19 other locations) |
| Status | Recruiting |
| Started | February 1, 2025 |
| Main results expected | December 15, 2031 |
| Study ends | December 15, 2033 |
| Registry record updated | April 13, 2026 |
| Trial ID | NCT06419946 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–70 with newly diagnosed, IDH‑wildtype glioblastoma whose tumor shows MGMT promoter methylation and who have WHO performance status 0–2 without prior head radiotherapy or chemotherapy are ideal candidates.
✕Probably not a fit
Patients with unmethylated MGMT, IDH‑mutant tumors, poor performance status, prior relevant treatments, or serious comorbidities are unlikely to benefit from this trial's experimental approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized Phase 3 trial that compares standard treatment (temozolomide during and after radiation) to the same regimen with lomustine added. Eligible participants are adults 18–70 with newly diagnosed IDH‑wildtype glioblastoma and a methylated MGMT promoter and a WHO performance status of 0–2. Patients are randomly assigned to one of the two treatment arms and followed for survival, safety, and quality‑of‑life outcomes. The trial builds on prior randomized data suggesting potential benefit from combining lomustine with temozolomide in this molecular subgroup.
Why it matters
Potential benefit: If successful, adding lomustine could extend overall survival for patients with newly diagnosed, MGMT‑methylated, IDH‑wildtype glioblastoma.
How similar studies have gone: Previous randomized data such as the NOA‑09 trial provided preliminary evidence that adding lomustine to temozolomide may improve outcomes in MGMT‑methylated glioblastoma, but results are not yet definitive.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Kepler University Hospital
Linz, Austria Recruiting -
Aarhus University Hospital
Aarhus, Denmark Recruiting -
Haukeland University Hospital
Bergen, Norway Recruiting -
Sorlandet Sykehus
Kristiansand, Norway Recruiting -
Oslo University Hospital
Oslo, Norway Recruiting -
Gävle Hospital
Gävle, Sweden Recruiting
Show 14 more locations
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Sahlgrenska University Hospital
Gothenburg, Sweden Recruiting -
Ryhov County Hospital
Jönköping, Sweden Recruiting -
Kalmar Country Hospital
Kalmar, Sweden Recruiting -
Örebro University Hospital
Örebro, Sweden Recruiting -
Norrlands Universitetssjukhus, Umea, Sweden
Umeå, Sweden Recruiting -
Uppsala University Hospital
Uppsala, Sweden Recruiting -
University Hospital Graz
Graz, Austria Not yet recruiting -
Medizinische Universität Innsbruck
Innsbruck, Austria Not yet recruiting -
University Hospital St. Pölten
Sankt Pölten, Austria Enrolling by invitation -
Stavanger University Hospital
Stavanger, Norway Not yet recruiting -
St Olavs Hospital
Trondheim, Norway Not yet recruiting -
Skåne University Hospital
Lund, Sweden Not yet recruiting -
Karolinska Institutet
Stockholm, Sweden Enrolling by invitation -
Sundsvall Hospital
Sundsvall, Sweden Enrolling by invitation
Study contacts
- Principal investigator: Annika Malmström, MD, PhD — University Hospital, Linkoeping
- Study coordinator: Asgeir S Jakola, MD, PhD
- Email: asgeir.jakola@vgregion.se
- Phone: +46313429741
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.