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

Summary

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

• Glioblastoma, IDH-wildtype
• MGMT-Methylated Glioblastoma

Interventions

DRUG

Temozolomide

In the experimental treatment arm: a combination of Temozolomide and Lomustine, taken together, two separate pills

DRUG

Lomustine

In the experimental treatment arm: a combination of Temozolomide and Lomustine, taken together, two separate pills

Sponsors & Collaborators

• Skane University Hospital

  collaborator OTHER

• Gävle Hospital

  collaborator OTHER

• Karolinska Institutet

  collaborator OTHER

• Sahlgrenska University Hospital

  collaborator OTHER

• Ryhov County Hospital

  collaborator OTHER

• Kalmar County Hospital

  collaborator OTHER

• Oslo University Hospital

  collaborator OTHER

• St. Olavs Hospital

  collaborator OTHER

• Haukeland University Hospital

  collaborator OTHER

• Sorlandet Hospital HF

  collaborator OTHER_GOV

• Helse Stavanger HF

  collaborator OTHER_GOV

• Aarhus University Hospital

  collaborator OTHER

• Region Örebro County

  collaborator OTHER

• Norrlands Universitetssjukhus, Umea, Sweden

  collaborator UNKNOWN

• Uppsala University Hospital

  collaborator OTHER

• University Hospital Graz

  collaborator UNKNOWN

• University Hospital of Sankt Pölten

  collaborator UNKNOWN

• Sundsvalls Hospital

  collaborator UNKNOWN

• Kepler University Hospital

  collaborator OTHER

• medizinische universität innsbruck, Austria

  collaborator UNKNOWN

• Vastra Gotaland Region

  lead OTHER_GOV

Principal Investigators

• Annika Malmström, MD, PhD · University Hospital, Linkoeping

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-01

Primary Completion

2031-12-15

Completion

2033-12-15

Countries

• Austria
• Denmark
• Norway
• Sweden

Study Locations