Adding lomustine to standard care for MGMT‑methylated glioblastoma
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)
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 |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Vastra Gotaland Region Government |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 20 sites (Graz and 19 other locations) |
| Trial ID | NCT06419946 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Graz and 19 other locations
- University Hospital Graz — Graz, Austria (Not_yet_recruiting)
- Medizinische Universität Innsbruck — Innsbruck, Austria (Not_yet_recruiting)
- Kepler University Hospital — Linz, Austria (Recruiting)
- University Hospital St. Pölten — Sankt Pölten, Austria (Enrolling_by_invitation)
- Aarhus University Hospital — Aarhus, Denmark (Recruiting)
- Haukeland University Hospital — Bergen, Norway (Recruiting)
- Sorlandet Sykehus — Kristiansand, Norway (Recruiting)
- Oslo University Hospital — Oslo, Norway (Recruiting)
- Stavanger University Hospital — Stavanger, Norway (Not_yet_recruiting)
- St Olavs Hospital — Trondheim, Norway (Not_yet_recruiting)
- Gävle Hospital — Gävle, Sweden (Recruiting)
- Sahlgrenska University Hospital — Gothenburg, Sweden (Recruiting)
- Ryhov County Hospital — Jönköping, Sweden (Recruiting)
- Kalmar Country Hospital — Kalmar, Sweden (Recruiting)
- Skåne University Hospital — Lund, Sweden (Not_yet_recruiting)
- Örebro University Hospital — Örebro, Sweden (Recruiting)
- Karolinska Institutet — Stockholm, Sweden (Enrolling_by_invitation)
- Sundsvall Hospital — Sundsvall, Sweden (Enrolling_by_invitation)
- Norrlands Universitetssjukhus, Umea, Sweden — Umeå, Sweden (Recruiting)
- Uppsala University Hospital — Uppsala, Sweden (Recruiting)
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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.