Adding Lomustine to Temozolomide for Methylated MGMT Glioblastoma
Tests adding lomustine to temozolomide in adults with newly diagnosed brain glioblastoma.
Plain-language title generated from the registry record
Registry title: Lomustine in Addition to Standard of Care in Patients With MGMT Methylated Glioblastoma
Key facts
- Where
- Aarhus, DenmarkSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
- Has your doctor told you that the MGMT gene in your tumour is "methylated" or "unmethylated"?
- Has a test on your tumour shown it is "IDH wild-type"?
- Have you had radiotherapy to your head or brain?
Source: NCT06419946, who can take part
Where in Denmark
- Aarhus University HospitalAarhus, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Vastra Gotaland Region
- Trial code
- NCT06419946
- Record updated
- 13 April 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: Newly diagnosed glioblastoma/gliosarcoma, IDH wild type; Methylated MGMT promoter; World Health Organization performance status 0-2; Age 18-70.
Exclusion: Previous chemotherapy or radiotherapy involving the head; Previous malignancy within 3 y or malignancy treated non-curatively; Off-protocol tumor-specific treatment; Serious comorbidity.