Actively Recruiting

Phase 3
Age: 18Years - 70Years
All Genders
NCT06419946

Lomustine in Addition to Standard of Care in Patients With MGMT Methylated Glioblastoma

Led by Vastra Gotaland Region · Updated on 2026-04-13

200

Participants Needed

20

Research Sites

462 weeks

Total Duration

On this page

Sponsors

V

Vastra Gotaland Region

Lead Sponsor

S

Skane University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Lomustine in Addition to Standard of Care in Patients With MGMT Methylated Glioblastoma

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Newly diagnosed glioblastoma or gliosarcoma, IDH wild type
  • Methylated MGMT promoter
  • World Health Organization performance status 0 to 2
  • Age between 18 and 70 years
Not Eligible

You will not qualify if you...

  • Previous malignancy within 3 years or malignancy treated non-curatively
  • Previous chemotherapy or radiotherapy involving the head
  • Off-protocol tumor-specific treatment
  • Serious comorbidity

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 20 locations

1

University Hospital Graz

Graz, Austria

Not Yet Recruiting

2

Medizinische Universität Innsbruck

Innsbruck, Austria

Not Yet Recruiting

3

Kepler University Hospital

Linz, Austria

Actively Recruiting

4

University Hospital St. Pölten

Sankt Pölten, Austria

Enrolling by Invitation

5

Aarhus University Hospital

Aarhus, Denmark

Actively Recruiting

6

Haukeland University Hospital

Bergen, Norway

Actively Recruiting

7

Sorlandet Sykehus

Kristiansand, Norway

Actively Recruiting

8

Oslo University Hospital

Oslo, Norway

Actively Recruiting

9

Stavanger University Hospital

Stavanger, Norway

Not Yet Recruiting

10

St Olavs Hospital

Trondheim, Norway

Not Yet Recruiting

11

Gävle Hospital

Gävle, Sweden

Actively Recruiting

12

Sahlgrenska University Hospital

Gothenburg, Sweden

Actively Recruiting

13

Ryhov County Hospital

Jönköping, Sweden

Actively Recruiting

14

Kalmar Country Hospital

Kalmar, Sweden

Actively Recruiting

15

Skåne University Hospital

Lund, Sweden

Not Yet Recruiting

16

Örebro University Hospital

Örebro, Sweden

Actively Recruiting

17

Karolinska Institutet

Stockholm, Sweden

Enrolling by Invitation

18

Sundsvall Hospital

Sundsvall, Sweden

Enrolling by Invitation

19

Norrlands Universitetssjukhus, Umea, Sweden

Umeå, Sweden

Actively Recruiting

20

Uppsala University Hospital

Uppsala, Sweden

Actively Recruiting

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Research Team

A

Asgeir S Jakola, MD, PhD

CONTACT

A

Annika Malmström, MD. PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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