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.
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
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.
19 sites in 6 countries
France7 sites, 7 recruiting
- 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
Germany4 sites, 4 recruiting
- 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
Austria2 sites, 2 recruiting
- Recruiting
A.O Landeskrankenhaus - Innsbruck Universitaetsklinik
Innsbruck, 6020
- Recruiting
Universitaetskliniken der Uni Wien - Universitaetsklinikum Wien - AKH unikliniken
Vienna, 1090
Norway2 sites, 2 recruiting
- 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
Spain2 sites, 2 recruiting
- 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
Switzerland2 sites, 2 recruiting
- Not yet 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
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.
- Conditions
- Recurrent Meningioma
- 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 group | Role | What they receive |
|---|---|---|
| Control group: local standard of care (LOC) | Active comparator | According 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-DOTATATE | Experimental | Patients 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.
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)
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)
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)
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)
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.
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.
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.
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.
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.
- First posted22 Mar 2024
- Study start10 Mar 2025
- Primary completion14 Apr 2027 (estimated)
- Study completion22 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent MeningiomaStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- Research network
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Prof. Nathalie Albert, Principal investigator, EORTC Study Coordinator
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