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Study Comparing Lomustine Alone and Lomustine with Bevacizumab for Patients with Recurrent Glioblastoma

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of brain cancer called glioblastoma, which is known for being aggressive and difficult to treat. The study is investigating the effects of two treatments: lomustine, a medication that comes in capsule form, and bevacizumab, which is given as an infusion into a vein. The purpose of the study is to compare the effectiveness of using lomustine alone versus using a combination of lomustine and bevacizumab in patients whose glioblastoma has returned after initial treatment.

Participants in the study will be randomly assigned to receive either lomustine by itself or the combination of lomustine and bevacizumab. The study will monitor the overall survival of participants, which means the length of time they live after starting the treatment. Additionally, the study will look at how long patients remain free from cancer progression, the response to the treatment, and the safety of the combination therapy compared to lomustine alone.

The trial is expected to last for several years, with the goal of gathering enough information to determine the best treatment approach for recurrent glioblastoma. By participating in this study, researchers hope to find more effective ways to manage this challenging disease and improve the quality of life for those affected by it.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of glioblastoma and ensuring previous treatment according to the STUPP regimen.

    Eligibility criteria include being over 18 years old, having a performance status of 0-1, and an expected survival of more than 3 months.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two groups: one receiving lomustine alone, and the other receiving a combination of lomustine and bevacizumab.

  3. Step 3

    Treatment administration

    For those in the combination group, bevacizumab is administered as an intravenous infusion. The specific dosage and frequency are determined by the study protocol.

    Lomustine is taken orally in the form of a hard capsule. The dosage and schedule are also specified by the study protocol.

  4. Step 4

    Monitoring and follow-up

    Participants undergo regular monitoring to assess the treatment's effectiveness and any side effects. This includes evaluating overall survival and progression-free survival at 6 and 12 months.

    The study also measures the response rate and duration of response, following specific criteria.

  5. Step 5

    Completion and analysis

    The trial is estimated to conclude by December 2026. Upon completion, data is analyzed to determine the safety and feasibility of the treatment combinations, as well as overall survival outcomes.

Who can join the trial?

9 criteria

  • You must provide a signed informed consent, which means you agree to participate in the study after understanding all the details.
  • You need to have a confirmed diagnosis of glioblastoma, a type of brain cancer.
  • Your glioblastoma must have come back after being treated with the STUPP regimen, a standard treatment for this condition.
  • You should not have had more than one type of chemotherapy treatment. This includes treatments with temozolomide, a common chemotherapy drug, even if it was used with another experimental drug.
  • Your Performance Status (PS) should be 0-1, which means you are fully active or have some symptoms but can still do light work.
  • You must be older than 18 years.
  • You should have an expected survival time of more than 3 months.
  • Your cancer should have progressed for the first time after receiving radiation therapy and chemotherapy. If it progressed early, it should be at least 3 months after finishing radiation therapy and at least 4 weeks after finishing chemotherapy.
  • You should not have had more than one type of chemotherapy treatment.

Who cannot join the trial?

10 criteria

  • Patients with any other serious medical condition that could interfere with the study.
  • Patients who are unable to follow the study procedures or instructions.
  • Patients who have participated in another clinical trial recently.
  • Patients who are pregnant or breastfeeding.
  • Patients with a history of allergic reactions to the study medication.
  • Patients who have not recovered from a recent surgery or medical procedure.
  • Patients with certain types of infections that could affect the study results.
  • Patients who are taking medications that might interfere with the study treatment.
  • Patients with a history of substance abuse that could affect their ability to participate.
  • Patients with mental health conditions that could interfere with their participation.
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Investigated drugs

  • Lomustine

    is a type of chemotherapy medication used to treat brain tumors, including glioblastoma. It works by slowing or stopping the growth of cancer cells.

  • Bevacizumab

    is a medication that helps to prevent the growth of new blood vessels that tumors need to grow. It is used in combination with other treatments to manage certain types of cancer, including recurrent glioblastoma.

What is already known about the treatment

  • Lomustine

    Lomustine is administered orally in capsule form and is used primarily in the treatment of brain tumors, such as glioblastoma. It is an alkylating agent that works by interfering with the DNA of cancer cells, preventing them from dividing and growing. Lomustine is well-documented in medical literature and is commonly used in oncology for its effectiveness in treating certain types of cancer. It is classified as a chemotherapy drug and is often part of combination therapy to enhance its therapeutic effects.

  • Bevacizumab

    Bevacizumab is administered through intravenous infusion and is used to treat various types of cancer, including glioblastoma. It works by inhibiting the growth of blood vessels that supply nutrients to tumors, effectively starving the cancer cells. Bevacizumab is widely recognized in medical literature and is approved for use in several cancer treatments. It is classified as a monoclonal antibody and is often used in combination with other chemotherapy agents to improve patient outcomes.

Investigated diseases

Glioblastoma – Glioblastoma is a type of brain cancer that originates from glial cells, which support nerve cells in the brain. It is known for its aggressive nature and rapid growth, often infiltrating surrounding brain tissue. Symptoms can vary depending on the tumor's location but may include headaches, seizures, and changes in personality or cognitive function. As the disease progresses, these symptoms typically worsen, and new neurological deficits may appear. Glioblastoma is characterized by its tendency to recur even after treatment, making it a challenging condition to manage. The tumor's growth and impact on brain function are central to its progression.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519437-27-02Protocol codeEnglishEstimated enrolment168 patientsSponsorRegion Hovedstaden

sourced from the EU Clinical Trials Register and site verification

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