Clinical trial Recruiting at 12 sites Phase 3 Interventional Ages 18 to 70

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

PhasePhase 3
Study typeInterventional
Ages18 Years to 70 Years
SexAll
Enrollment200 (estimated)
SponsorVastra Gotaland Region
Government
Drugs / interventionschemotherapy, radiation
Locations20 sites (Graz and 19 other locations)
StatusRecruiting
StartedFebruary 1, 2025
Main results expectedDecember 15, 2031
Study endsDecember 15, 2033
Registry record updatedApril 13, 2026
Trial IDNCT06419946 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.