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Study on Everolimus and Lutetium (177Lu) Oxodotreotide for Treating Grades 2 and 3 Refractory Meningioma in Patients

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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 tumor called meningioma, specifically grades 2 and 3, which are more challenging to treat. The study is exploring the effectiveness of combining two treatments: Everolimus, a medication taken as a tablet, and 177Lu-DOTATATE, also known as Lutathera, which is given as an infusion directly into the bloodstream. The purpose of the study is to see if this combination can help control the growth of the tumor in patients whose meningioma has not responded to other treatments.

Participants in the study will receive the treatments over a period of several months. Everolimus is taken orally, meaning it is swallowed as a pill, while 177Lu-DOTATATE is administered through an intravenous infusion, which means it is delivered directly into a vein. The study will monitor how the tumor responds to this combination of treatments and will also track any side effects that may occur. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatment.

The trial aims to provide valuable information on whether adding Everolimus to 177Lu-DOTATATE can improve outcomes for patients with these specific types of meningioma. Throughout the study, participants will undergo regular check-ups and imaging tests, such as MRI scans, to assess the tumor's response to the treatment. The study is expected to continue for several years to gather comprehensive data on the effectiveness and safety of this treatment approach.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history, a brain MRI, and a 68Ga-DOTATOC PET scan to evaluate the presence of somatostatin receptors.

    Eligibility criteria include being an adult under 80 years old, having a grade 2 or 3 meningioma not suitable for surgery or radiotherapy, and showing clinical or radiological progression.

  2. Step 2

    Treatment cycle 1

    The first treatment cycle begins with the administration of Lutathera (lutetium (177lu) oxodotreotide) as a solution for infusion. This is given intravenously.

    In addition, Everolimus tablets are taken orally. The dosage and frequency are determined by the study protocol.

  3. Step 3

    Monitoring and evaluation

    After the first cycle, monitoring includes skull scans with 177Lu-DOTATATE SPECT-CT on days 1 and 7 to calculate the dose delivered to the tumor.

    Regular assessments are conducted to monitor tumor growth rate and any adverse events. These assessments follow the Common Terminology Criteria for Adverse Events (CTCAE) classification.

  4. Step 4

    Subsequent treatment cycles

    Additional treatment cycles with Lutathera and Everolimus are administered as per the study schedule.

    The frequency and duration of these cycles are determined by the study protocol and the patient's response to treatment.

  5. Step 5

    Follow-up assessments

    Follow-up assessments include evaluating overall survival and quality of life using the EORTC QLQ-C30 questionnaire at specified intervals.

    The primary endpoint is progression-free survival at 6 months (PFS-6), assessed according to the RANO criteria.

  6. Step 6

    End of trial

    The trial is estimated to conclude by May 2028. Final assessments will be conducted to evaluate the long-term efficacy and safety of the treatment.

Who can join the trial?

9 criteria

  • Adult patient under 80 years old who has been fully informed about the trial and has signed the consent form.
  • Eligible for a special access program for treatment, as determined by a national board of neuro-oncology experts.
  • Has a WHO performance status of 3 or less, which is a scale that measures how well a patient can perform daily activities.
  • Has grade 2 or 3 meningioma, confirmed by a tissue sample, that cannot be treated with surgery or radiation, and is showing signs of getting worse.
  • Shows clinical decline or at least 10% tumor growth within 6 months, measured by the size of the tumor.
  • Has somatostatin receptors on the tumor, as shown by a special scan called 68Ga-DOTATOC PET, which helps to see if the tumor absorbs a certain substance.
  • Has had a brain MRI and 68Ga-DOTATOC PET scan in the last 2 months.
  • Women of childbearing age must use effective birth control.
  • Has social security coverage.
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Investigated drugs

  • Everolimus

    is a medication used in this trial to help treat certain types of brain tumors called meningiomas. It works by blocking a specific protein that helps cancer cells grow, which may slow down or stop the growth of the tumor.

  • 177Lu-DOTATATE

    is a type of targeted radiation therapy used in this trial. It delivers radiation directly to the tumor cells, which can help to shrink the tumor or slow its growth. This therapy is often used for treating certain types of tumors that have specific receptors on their surface.

What is already known about the treatment

  • Everolimus

    Everolimus is administered orally in tablet form. It is currently being studied in clinical trials for its effectiveness in treating certain types of brain tumors, specifically grades 2 and 3 refractory meningioma. The medication works by inhibiting a protein called mTOR, which plays a role in cell growth and proliferation. Everolimus is classified as an mTOR inhibitor and is used to slow down or stop the growth of cancer cells.

  • 177Lu-DOTATATE

    177Lu-DOTATATE is administered intravenously. It is a radiopharmaceutical currently under investigation for its potential to treat grades 2 and 3 refractory meningioma. This medication targets somatostatin receptors on tumor cells, delivering targeted radiation to destroy them. It is classified as a peptide receptor radionuclide therapy (PRRT) and is used to treat tumors that express somatostatin receptors.

Investigated diseases

Meningioma – Meningioma is a type of tumor that develops from the meninges, the protective membranes covering the brain and spinal cord. It is typically a slow-growing tumor and is often benign, meaning it is not cancerous. However, some meningiomas can be atypical or malignant, which means they can grow more aggressively. The progression of meningioma can lead to symptoms such as headaches, vision problems, or seizures, depending on its size and location. As the tumor grows, it may exert pressure on the brain or spinal cord, leading to neurological symptoms. Meningiomas are more common in older adults and are more frequently diagnosed in women than in men.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508400-38-00Protocol code2021PI203Estimated enrolment28 patientsSponsorCHRU De Nancy

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