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New combo aims to stall aggressive brain tumors when surgery and radiation fail

NCT ID NCT06126588

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase IIb trial tests whether combining the drug everolimus with a targeted radiation therapy (177Lu-DOTATATE) can slow tumor growth in people with grades 2 and 3 meningioma that no longer responds to surgery or radiation. About 28 adults will receive the combination for 7 months. The main goal is to see how long the tumor stays under control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
everolimus and 177Lu-DOTATATE
What this could lead to
If successful, this combination could offer a new treatment option that slows tumor growth and extends survival for people with aggressive, hard-to-treat meningioma.
What could go wrong
This is a small, early-phase trial with only 28 participants. The combination may not work better than existing options, and side effects from the drugs could be significant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 28 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult patient \< 80 years old, who received a complete comprehensive briefing about the trial and signed the informed consent * Eligible patient for compassional access program (National Multidisciplinary Neuro-Oncology board to Lutathera ® traitement * WHO performance status ≤ 3 * Patient with grade 2 and 3 meningioma, substantiated by histology, not amenable to surgery or radiotherapy, with clinical or radiological progression * Clinical deterioration or at least 10% of tumor growth rate, defined as the product of the two largest diameters of the target lesion within 6 months * Expressing somatostatin receptors as determined by 68Ga-DOTATOC PET (lesion uptake ≥ liver uptake and/or 1.7 fold SUVpeak of the controlateral meninges). * Patient that underwent a brain MRI and 68Ga-DOTATOC PET within the last 2 months. * Effective contraception required for women of childbearing age. * Patient with social security cover. Exclusion Criteria: * Hypersensitivity to everolimus. * Contraindication to 177Lu-DOTATATE: renal failure GFR\<40 mL/min/1.73m2 (calculated by the CKD-Epi Formula), hepatic failure total bilirubin \>3N, heart failure NYHA III or IV. Patients should not take the following treatments: * Other rapamycin derivatives (sirolimus, temsirolimus, deforolimus). * Other immunosuppressants * Co-administration with potent inhibitors and inducers of CYP3A4 and/or the multidrug efflux pump P-glycoprotein (PgP) : Ketoconazole , itraconazole, posaconazole, voriconazole, telithromycin, clarithromycin, Nefazodone, Ritonavir, atazanavir, saquinavir, darunavir, indinavir, nelfinavir. * If everolimus is taken with orally administered CYP3A4 substrates with a narrow therapeutic index (e.g. pimozide, terfenadine, astemizole, cisapride, quinidine or ergot alkaloid derivatives), the patient should be monitored for undesirable effects described in the product information of the orally administered CYP3A4 substrate. * Contraindication to MRI or 68Ga-DOTATOC PET/CT. * Person referred to and L. 3212-1 and L. 3213-1 (psychiatric care). * Women of childbearing age without effective contraception * Patient unable to attend follow-ups over a 12-month period. * Patients who participate in an interventional clinical research trial for the duration of the ELUMEN study. * Individuals referred to in Articles 10, 31, 32, 33 and 34 of Regulation (EU) No 536/2014. * Pregnant woman, birthing or breastfeeding mother * Minor (not emancipated) * Adult subject to a legal protection measure (such as guardianship, conservatorship) * Adult who is unable to give consent

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHRU of Nancy

    NOT_YET_RECRUITING

    Vandœuvre-lès-Nancy, Grand Est, 54511, France

  • Nancy Hospital

    RECRUITING

    Vandœuvre-lès-Nancy, 54511, France

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