New combo aims to stall aggressive brain tumors when surgery and radiation fail
NCT ID NCT06126588
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 Hide 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Meningioma are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
2 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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_RECRUITINGVandœuvre-lès-Nancy, Grand Est, 54511, France
-
Nancy Hospital
RECRUITINGVandœuvre-lès-Nancy, 54511, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Starving brain tumors of blood before surgery
- Brain tumor or aneurysm first? study weighs the safer sequence
- Brain surgery safety: live signal monitoring may shield speech, movement, and sight
- Could blocking a Tumor's blood supply shrink brain meningiomas?
- New platform trial takes on NF2 tumors with multiple drug strategies
- Could a cancer drug shrink brain tumors and save hearing in a rare nerve disorder?