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Recurrent MeningiomaPhase 2LUMEN-1NCT06326190

177Lu-DOTATATE for Recurrent Meningioma

A Phase 2 study testing 177Lu-DOTATATE in people with Recurrent Meningioma, run by European Organisation for Research and Treatment of Cancer - EORTC at 19 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Novel treatments are urgently needed for meningiomas progressing after local therapies (surgery, radiotherapy). So far, no effective systemic therapies are known in this situation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recurrent Meningioma
What is being tested?
177Lu-DOTATATE
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
19 sitesin 6 countries
Study dates
10 Mar 2025to 22 Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patient ≥ 18 years of age
  • Histologically confirmed diagnosis of meningioma (all grades, 1-3 per WHO CNS5, are eligible)
  • WHO performance status 0-2
  • Measurable disease (at least 10 x10 mm contrast enhancing lesion) on cranial MRI no more than two weeks prior to randomization
  • Radiologically documented progression of any existing tumour (growth > 25% in the last two years) or appearance of new lesions (including intra- and extracranial manifestations)
  • Somatostatin receptor (SSTR)-positive confirmed by PET imaging with scan performed within four weeks before randomization (baseline SSTR-PET is considered as positive when meningioma uptake intensity exceeds a SUVmax of 2.3).
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  • At least one prior surgery and one line of external beam radiotherapy for meningioma
  • Adequate liver, renal and haematological function within four weeks prior to randomization (1) Neutrophils ≥ 1.5 x 109/L, hemoglobin ≥ 9 g/dL or hemoglobin ≥ 5.6 mmol/L, platelets ≥ 100 x 109/L, (2) Total Bilirubin ≤ 1 x ULN, SGPT/ALT and SGOT/AST ≤ 2.5 x ULN, (3) Albumin ≥ 30 g/L, (4) Serum creatinine ≤ 1.5 x ULN, (5) Creatinine clearance > 40 ml/min as calculated by CKD-EPI 2021
  • Participants must have the following electrolyte values within normal limits or corrected to be within normal limits with supplements prior to first dose of study medication: (1) Potassium (potassium level of up to 6.0 mmol/L is acceptable at study entry if associated with creatinine clearance within normal limits calculated using CKD-EPI formula). Mild decrease below lower limit of normal (LLN) is acceptable at study entry if considered not clinically significant by investigator, (2) Magnesium, with the exception of magnesium level > ULN - 3.0 mg/dL (1.23 mmol/L) associated with creatinine clearance within normal limits calculated using CKD-EPI formula. Mild decrease below LLN is acceptable at study entry if considered not clinically significant by Investigator, (3) Total calcium (corrected for serum albumin) level of up to 12.5 mg/dL (3.1 mmol/L) is acceptable at study entry if associated with creatinine clearance within normal limits calculated using CKD-EPI formula. Mild decrease below LLN is acceptable at study entry if considered not clinically significant by Investigator.
  • Patients who are receiving corticosteroid treatment with dexamethasone, must be treated with a dose of ≤4 mg/day (or other corticosteroids equivalent dose) for a minimum of 7 days initiation of study treatment.
  • Women of childbearing potential (WOCBP) must have a negative serum (or urine) pregnancy test within 72 hours prior to randomization. A positive urine pregnancy test result must immediately be confirmed using a serum test. A pregnancy test is to be reported within 7 days prior to the first dose of the study treatment. Note: women of childbearing potential are defined as premenopausal females capable of becoming pregnant (i.e., females who have had any evidence of menses in the past 12 months, with the exception of those who had prior hysterectomy). However, women who have been amenorrhoeic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antioestrogens, low body weight, ovarian suppression, or other reasons.
  • Patients of childbearing / reproductive potential should use adequate birth control measures during the study treatment period and for at least 6 months after the last dose of treatment. A highly effective method of birth control is defined as a method which results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly. Such methods include: (1) Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), (2) Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), (3) Intrauterine device (IUD), (4) Intrauterine hormone-releasing system (IUS), (5) Bilateral tubal occlusion, (6) Vasectomized partner, (7) Sexual abstinence (the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient)
  • Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 7 months after the last study treatment.
  • Before patient 's enrolment, written informed consent must be given according to ICH/GCP, and national/local regulations.

Who cannot join

  • Local therapy (surgery and / or radiotherapy) indicated per local investigator. Note: in case of patients with multiple meningioma lesions, in whom resection and / or radiotherapy of individual lesions is indicated, patients may be included after local therapy (with a 4-week gap between surgery / end of radiotherapy and start of treatment), if at least one remaining lesion fulfils the inclusion criteria.
  • Any combined or any prior systemic treatment regardless the timing.
  • Life expectancy is less than nine weeks.
  • History of any other invasive malignancy within the last five years (except adequately treated non-melanoma skin cancer, clinically localized and very low-risk prostate cancer, and adequately treated cervical intraepithelial neoplasia)
  • Suspected pregnancy or when pregnancy has not been excluded
  • Contraindication to MRI, CT or PET
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  • Unstable cardiac conditions (congestive heart failure, angina pectoris, myocardial infarction within one year before randomization, uncontrolled hypertension, clinically significant arrhythmias)
  • Psychological, familial, sociological, or geographical conditions potentially hamper compliance with the study protocol and follow-up schedule.
  • Known hypersensitivity to the active substance or to any excipients.

Trial locations and contacts

19 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

EORTC contact

+32 2 774 16 11

eortc@eortc.org

19 sites in 6 countries

France7 sites, 7 recruiting

  • Centre Leon Berard

    Lyon, 69008

    Recruiting

  • CHU de Lyon - CHU Lyon - Hopital neurologique Pierre Wertheimer

    Lyon, 69500

    Dr François Ducray

    Recruiting

  • Assistance Publique - Hopitaux de Marseille APHM - Hopital de La Timone (APHM)

    Marseille, 13005

    Recruiting

  • Centre Eugene Marquis

    Rennes, 35042

    Dr. Elodie Vauleon

    Recruiting

  • CHU de Toulouse - Institut Claudius Regaud - IUCT oncopole

    Toulouse, 31100

    Dr Vija Lavinia

    Recruiting

  • CHRU de Nancy - Hopitaux De Brabois

    Vandœuvre-lès-Nancy, 54511

    Recruiting

  • Gustave Roussy

    Villejuif, 94805

    Recruiting

Other trials in France

Germany4 sites, 4 recruiting

  • Universitaetsklinikum - Essen

    Essen, 45147

    Dr. Sied Kebir

    Recruiting

  • University Frankfurt - Goethe Univ. - University Hospital Frankfurt- Klinik für Neurologie Funktionsbereich Neuroonkologie

    Frankfurt, 60590

    Dr Michael Burger

    Recruiting

  • Universitaetsklinikum Heidelberg - UniversitaetsKlinikum Heidelberg - Head Hospital

    Heidelberg, 69120

    Prof. Antje Wick

    Recruiting

  • Ludwig-Maximilians-Universitaet Muenchen - Campus Grosshadern

    München, 81377

    Prof. Louisa von Baumgarten

    Recruiting

Other trials in Germany

Austria2 sites, 2 recruiting

  • A.O Landeskrankenhaus - Innsbruck Universitaetsklinik

    Innsbruck, 6020

    Recruiting

  • Universitaetskliniken der Uni Wien - Universitaetsklinikum Wien - AKH unikliniken

    Vienna, 1090

    Recruiting

Other trials in Austria

Norway2 sites, 2 recruiting

  • Oslo University Hospital - Radiumhospitalet

    Oslo, 0379

    Dr. Petter Brandal

    Recruiting

  • St Olavs University Hospital - St. Olavs Hospital, Trondheim University Hospital

    Trondheim, 7030

    Prof. Tora Solheim

    Recruiting

Other trials in Norway

Spain2 sites, 2 recruiting

  • Vall D Hebron - Hospital Universitari Vall d'Hebron -Vall d'Hebron Institut Oncologia

    Barcelona, 08035

    Dr. Maria Vieito Villar

    Recruiting

  • Hospital Universitario 12 De Octubre

    Madrid, 28041

    Dr. Juan Manuel Sepulveda

    Recruiting

Other trials in Spain

Switzerland2 sites, 2 recruiting

  • Oncology Institute of Southern Switzerland (IOSI) - Ospedale San Giovanni

    Bellinzona, 6500

    Prof. Gaetano Paone

    Not yet recruiting

  • UniversitaetsSpital Zurich - Neurology Clinic

    Zurich, 8091

    Prof. Michael Weller

    Not yet recruiting

Other trials in Switzerland

About this study

Official title: 177Lu-DOTATATE for Recurrent Meningioma: a Randomized Phase II Study

Novel treatments are urgently needed for meningiomas progressing after local therapies (surgery, radiotherapy). So far, no effective systemic therapies are known in this situation. The LUMEN-1 trial will investigate in a prospective randomized trial the efficacy of the precision medicine "theranostic" concept of combining diagnostic patient selection using PET-based molecular imaging and target-specific therapeutic intervention using a systemically administered radioligand.

The rationale for the LUMEN-1 trial is based on the following: (a) high somatostatin receptor (SSTR) expression in meningiomas, (b) wide-spread availability of clinically established SSTR-PET imaging, (c) proven efficacy of SSTR-targeting radioligand therapy using [177Lu]Lu-DOTATATE in another tumor type (neuroendocrine tumors), and (d) promising experiences with [177Lu]Lu-DOTATATE therapy in compassionate use applications and retrospective case series and interim results from one ongoing uncontrolled prospective trial in meningiomas. LUMEN-1 is the first randomized clinical trial to investigate [177Lu]Lu-DOTATATE therapy in refractory meningioma and may open new avenues for treatment and research in this area.

Being tested
Local standard of Care, 177Lu-DOTATATE
Keywords
177Lu-DOTATATE, Meningioma, Recurrent Meningioma, Phase II
Medical subject headings
Meningioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Local standard of CareDrug

    Also called Hydroxycarbamide, Bevacizumab, Sunitinib, Octreotide (Sandostatin LAR)

    According to local standard practice, treatment or no treatment in the control arm is left to the investigator's discretion.

  • 177Lu-DOTATATEDrug

    Also called ¹⁷⁷Lu-DOTA0-TATE, Lutathera®, Lu oxodotreotide

    Intravenous injection of 177Lu-DOTATATE

Study groups in NCT06326190
Study groupRoleWhat they receive
Control group: local standard of care (LOC)Active comparatorAccording to local standard practice, treatment in the control arm is left to the investigator's discretion. * Hydroxyurea * Bevacizumab * Sunitinib * Octreotide (Sandostatin LAR) * Everolimus * No treatment (observation with regular follow-up and best supportive care)
Receives: Drug: Local standard of Care
Experimental group: 177Lu-DOTATATEExperimentalPatients will receive 177Lu-DOTATATE with a total dose of 7.4 GBq/cycle every four (4) weeks for four (4) cycles as an IV infusion
Receives: Drug: 177Lu-DOTATATE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

    To examine whether [177Lu]Lu-DOTATATE demonstrates sufficient antitumor activity in patients with recurrent meningioma to justify further investigation. Progression-free survival computed based on MRI-based RANO meningioma response criteria as assessed by the local investigator.

    Measured: From the date of randomization till the date of disease progression or death (time till death is up to 2 years after patient enrolment in the study)

Secondary outcomes (8)

  1. Overall Survival (OS)

    Overall survival (OS), OS probability at 6 (OS6) and 12 months (OS12), median OS (mOS)

    Measured: From the date of randomization till the date of death (time till death is up to 2 years after patient enrolment in the study)

  2. Radiological response rate

    Best overall response (BOR, defined as CR, MR or PR during study treatment) rate. Complete response (CR) rate is computed by MRI based RANO meningioma response criteria as assessed by the local investigator.

    Measured: From the date of randomization till the date of disease progression or death (time till death is up to 2 years after patient enrolment in the study)

  3. Radiological response rate

    Median best overall response (BOR, defined as CR, MR or PR during study treatment) duration. Median complete response (CR) duration is computed by MRI based RANO meningioma response criteria as assessed by the local investigator.

    Measured: From the date of randomization till the date of disease progression or death (time till death is up to 2 years after patient enrolment in the study)

  4. The magnitude of change in Health-related quality of life (HRQoL)

    The magnitude of change in HRQoL in terms of global health status from EORTC QLQ-C30 during treatment.

    Measured: From the date of randomization regardless of progression status up to 2 years after patient enrolment in the study.

  5. The magnitude of change in Health-related quality of life (HRQoL)

    The magnitude of change in HRQoL in terms of physical functioning from EORTC QLQ-C30 during treatment.

    Measured: From the date of randomization regardless of progression status up to 2 years after patient enrolment in the study.

  6. The magnitude of change in Health-related quality of life (HRQoL)

    The magnitude of change in HRQoL in terms of motor disfunction from EORTC QLQ-BN20 during treatment.

    Measured: From the date of randomization regardless of progression status up to 2 years after patient enrolment in the study.

  7. Neurological function (NANO scale)

    Change of neurological function (NANO scale) from baseline during study treatment.

    Measured: From the date of randomization regardless of progression status up to 2 years after patient enrolment in the study.

  8. Toxicity According to CTCAE Version 5.0

    This study will use the International Common Terminology Criteria for Adverse Events (CTCAE v5.0)

    Measured: From the date of randomization regardless of progression status up to 2 years after patient enrolment in the study.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2024
  2. Study start10 Mar 2025
  3. Primary completion14 Apr 2027 (estimated)
  4. Study completion22 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
136 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06326190
Sponsor's protocol ID
EORTC-2334-BTG
Acronym
LUMEN-1
Status last verified
Jun 2026
First submitted
14 Mar 2024
Last updated
15 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Albert NL, Tabouret E, Le Rhun E, Sahm F, Furtner J, Tonn JC, Alfano C, Silva JP, Govaerts AS, Gorlia T, Mirante O, Minniti G, Weller M, Preusser M; European Organisation for Research and Treatment of Cancer Brain Tumor Group. [177Lu]Lu-DOTATATE for Recurrent Meningioma (LUMEN-1, EORTC-2334-BTG): Study Protocol for a Randomized Phase II Trial. J Nucl Med. 2026 Jan 2;67(1):23-30. doi: 10.2967/jnumed.125.269633.

    PubMed 40774695

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 177Lu-DOTATATE in people with Recurrent Meningioma, run by European Organisation for Research and Treatment of Cancer - EORTC at 19 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in France, Germany, Austria, Norway, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact EORTC (+32 2 774 16 11, eortc@eortc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: From the date of randomization till the date of disease progression or death (time till death is up to 2 years after patient enrolment in the study)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06326190, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.

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