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Study on Lomustine and Temozolomide for Newly Diagnosed Glioblastoma Patients

Verified siteRegistered drugNo placebo
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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. The study is comparing two treatment approaches for patients who have been newly diagnosed with a specific form of glioblastoma, known as MGMT promoter methylated glioblastoma. The treatments being compared are a combination of two chemotherapy drugs, temozolomide and lomustine, versus the standard treatment with temozolomide alone. Some patients may also receive an additional therapy called tumor treating fields (Optune), which uses electric fields to disrupt cancer cell growth.

The purpose of the study is to determine if adding lomustine to the standard treatment with temozolomide improves the overall survival of patients. Participants in the study will receive either the combination of temozolomide and lomustine or temozolomide alone, along with standard radiotherapy. The study will also explore whether the use of tumor treating fields provides any additional benefit. The treatment period can last up to 66 weeks, and participants will be monitored for their response to the treatment and any side effects they may experience.

Throughout the study, various aspects will be evaluated, including how long patients live after starting the treatment, how long they remain free from cancer progression, and their quality of life. The study will also assess the impact of the treatments on patients' cognitive functions and any potential side effects related to the brain. The goal is to find out if the combination therapy offers a significant advantage over the standard treatment in terms of survival and overall well-being.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will provide written informed consent, confirming understanding of the study's purpose and procedures.

    Eligibility is confirmed based on specific criteria, including age, health status, and tumor characteristics.

  2. Step 2

    Initial treatment phase

    The patient will begin treatment with temozolomide (TMZ) or a combination of temozolomide and lomustine (LOM).

    The medication is administered orally, with the dosage and frequency determined by the study protocol.

  3. Step 3

    Radiotherapy

    Standard radiotherapy is administered alongside the chemotherapy regimen.

    The treatment may include the use of tumor treating fields (TTFields), a device that uses electric fields to disrupt cancer cell division.

  4. Step 4

    Ongoing treatment and monitoring

    The patient continues to receive chemotherapy cycles, with regular monitoring for any side effects or changes in health status.

    Progress is assessed through imaging tests, such as MRI, to evaluate the tumor's response to treatment.

  5. Step 5

    Evaluation of treatment outcomes

    The primary outcome measured is overall survival, from the start of the study until death or a follow-up period of at least 36 months.

    Secondary outcomes include progression-free survival, quality of life, and neurocognitive function.

  6. Step 6

    Completion of study participation

    Upon completion of the study, the patient will undergo a final assessment to evaluate the overall impact of the treatment.

    The study is estimated to conclude by March 2031, with recruitment starting in March 2024.

Who can join the trial?

11 criteria

  • Provide written informed consent, which means you agree to participate after understanding the study details.
  • Have adequate organ function, meaning your organs are working well enough as described in the study guidelines.
  • If you are on anticoagulation (blood-thinning medication), you may be included, but it is recommended to switch to a specific type of blood thinner called Low-molecular-weight heparin (LMWH) during treatment.
  • Be able to understand the reasons and need for the study treatment and procedures.
  • Have a newly diagnosed type of brain tumor called GBM, giant-cell GBM, or gliosarcoma, confirmed by a local specialist through various methods like surgery or biopsy.
  • Have a specific genetic feature in the tumor called methylated MGMT promoter, determined by local testing methods.
  • Be between 18-75 years old and have an estimated life expectancy of at least 12 weeks.
  • Have a WHO Performance Score of 0-2, which measures your ability to perform daily activities.
  • Be able to comply with study requirements and live close enough for regular follow-ups.
  • If you can have children, use an approved contraceptive method during and for 6 months after chemotherapy.
  • If you are a pre-menopausal woman who can have children, have a negative pregnancy test within 14 days before starting treatment.

Who cannot join the trial?

4 criteria

  • Patients who have a different type of brain tumor other than glioblastoma cannot participate. Glioblastoma is a specific type of brain cancer.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
  • Patients who do not meet the specific health and medical conditions required for the study cannot participate.
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Investigated drugs

  • Lomustine

    is a type of chemotherapy medication used in this trial. It is being tested in combination with another chemotherapy drug to see if it can improve survival rates for patients with a specific type of brain tumor. Lomustine works by slowing or stopping the growth of cancer cells.

  • Temozolomide (TMZ)

    is a standard chemotherapy drug used to treat certain brain cancers. In this trial, it is being used both alone and in combination with lomustine to determine if the combination is more effective than temozolomide alone. Temozolomide helps to kill cancer cells and is part of the standard treatment for this type of brain tumor.

  • Tumor Treating Fields (Optune)

    is a therapy that uses electric fields to disrupt cancer cell division. It is being tested in combination with chemotherapy to see if it can further improve treatment outcomes for patients with this type of brain tumor. This therapy is non-invasive and is used alongside other treatments to potentially enhance their effectiveness.

What is already known about the treatment

  • Lomustine

    Lomustine is administered orally in capsule form and is currently being studied in clinical trials for its effectiveness in treating glioblastoma, a type of brain cancer. It is often used in combination with other treatments to improve patient outcomes. Lomustine works by interfering with the DNA of cancer cells, preventing them from multiplying and spreading. It is classified as an alkylating agent, a type of chemotherapy drug.

  • Temozolomide

    Temozolomide is an oral medication used in the treatment of glioblastoma, particularly in patients with specific genetic markers. It is well-established in medical literature and is often part of standard treatment protocols. Temozolomide acts by damaging the DNA of cancer cells, which inhibits their growth and division. It belongs to the class of alkylating agents, which are commonly used in chemotherapy.

Investigated diseases

Glioblastoma – Glioblastoma is an aggressive type of cancer that occurs in the brain or spinal cord. It originates from astrocytes, which are cells that support nerve cells. This disease is known for its rapid growth and tendency to invade nearby brain tissue, making it difficult to treat. Symptoms can vary depending on the tumor's location but often include headaches, nausea, confusion, and memory problems. As the disease progresses, it can lead to more severe neurological symptoms, such as difficulty speaking, changes in personality, and seizures. Glioblastoma is considered a rare disease and is one of the most challenging brain tumors to manage.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506998-35-00Protocol codeTMZ-LOMEstimated enrolment200 patientsSponsorRegion Oestergoetland

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