Actively Recruiting
177Lu-DOTATATE for Recurrent Meningioma
Led by European Organisation for Research and Treatment of Cancer - EORTC · Updated on 2025-09-16
136
Participants Needed
12
Research Sites
197 weeks
Total Duration
On this page
Sponsors
E
European Organisation for Research and Treatment of Cancer - EORTC
Lead Sponsor
N
Novartis
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
177Lu-DOTATATE for Recurrent Meningioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patient 18 years of age or older
- Histologically confirmed meningioma of any grade (1-3 per WHO CNS5)
- WHO performance status between 0 and 2
- Measurable disease with at least one lesion 10 x 10 mm on cranial MRI within two weeks before randomization
- Radiological evidence of tumor progression greater than 25% in the last two years or new lesions
- Somatostatin receptor (SSTR) positive confirmed by PET imaging within four weeks before randomization
- At least one prior surgery and one line of external beam radiotherapy for meningioma
- Adequate liver, kidney, and blood function within four weeks prior to randomization
- Electrolyte levels within normal limits or corrected prior to first treatment dose
- If on corticosteroids like dexamethasone, dose must be 4 mg/day or less for at least 7 days before treatment
- Women of childbearing potential must have a negative pregnancy test within 72 hours before randomization
- Use of effective birth control during treatment and for at least 6 months after last dose
- Breastfeeding females must stop nursing before first dose and until 7 months after last dose
- Written informed consent given according to regulations
You will not qualify if you...
- Indication for local therapy such as surgery or radiotherapy at time of enrollment
- Any prior or combined systemic treatment for meningioma
- Life expectancy less than nine weeks
- History of other invasive cancers within last five years (except certain skin, prostate, or cervical conditions)
- Suspected or unexcluded pregnancy
- Contraindications to MRI, CT, or PET scans
- Unstable heart conditions including recent heart attack, uncontrolled hypertension, or serious arrhythmias
- Psychological, social, or geographical factors that may prevent study compliance
- Known allergy to the study drug or its components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
A.O Landeskrankenhaus - Innsbruck Universitaetsklinik
Innsbruck, Austria, 6020
Actively Recruiting
2
Universitaetskliniken der Uni Wien - Universitaetsklinikum Wien - AKH unikliniken
Vienna, Austria, 1090
Actively Recruiting
3
Centre Leon Berard
Lyon, France, 69008
Actively Recruiting
4
Centre Eugene Marquis
Rennes, France, 35042
Actively Recruiting
5
CHRU de Nancy - Hopitaux De Brabois
Vandœuvre-lès-Nancy, France, 54511
Actively Recruiting
6
Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
7
Oslo University Hospital - Radiumhospitalet
Oslo, Norway, 0379
Actively Recruiting
8
St Olavs University Hospital - St. Olavs Hospital, Trondheim University Hospital
Trondheim, Norway, 7030
Actively Recruiting
9
Vall D Hebron - Hospital Universitari Vall d'Hebron -Vall d'Hebron Institut Oncologia
Barcelona, Spain, 08035
Actively Recruiting
10
Hospital Universitario 12 De Octubre
Madrid, Spain, 28041
Actively Recruiting
11
Oncology Institute of Southern Switzerland (IOSI) - Ospedale San Giovanni
Bellinzona, Switzerland, 6500
Not Yet Recruiting
12
UniversitaetsSpital Zurich - Neurology Clinic
Zurich, Switzerland, 8091
Not Yet Recruiting
Research Team
E
EORTC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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