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Lutathera for the treatment of recurrent Meningioma (LUMEN-1)
EU CTIS ID: 2024-513443-93-00
What this study is testing
This randomized phase II trial aims to assess whether using [177Lu]Lu-DOTATATE on recurrent meningioma shows sufficient antitumor activity to justify further investigation.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult patient ≥ 18 years of age
- Patients of childbearing / reproductive potential should use adequate birth control measures during the study treatment period and for at least 7 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.
- 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.
- Histologically confirmed diagnosis of meningioma (all grades, 1-3 per WHO CNS5, are eligible)
- WHO performance status 0-2
You likely can't join if
- 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 prior systemic treatment regardless of the timing.
- Life expectancy is less than nine weeks.
- Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the study treatment.
- Contraindication to MRI, CT or PET
- Unstable cardiac conditions (congestive heart failure, angina pectoris, myocardial infarction within one year before enrolment, uncontrolled hypertension, clinically significant arrhythmias)
See the full eligibility criteria
Who can join
- Adult patient ≥ 18 years of age
- Patients of childbearing / reproductive potential should use adequate birth control measures during the study treatment period and for at least 7 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.
- 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.
- Histologically confirmed diagnosis of meningioma (all grades, 1-3 per WHO CNS5, are eligible)
- WHO performance status 0-2
- Measurable disease (at least 10 x 10 mm contrast enhancing lesion) on cranial MRI no more than two weeks prior to enrolment
- 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).
- At least one prior surgery and one line of external beam radiotherapy for meningioma, if technically feasible
- Adequate liver, renal and haematological function within four weeks prior to enrolment
- 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: • Potassium (potassium level of up to 6.0 mmol/L is acceptable at study entry if associated with creatinine clearance ≥ 60 mL/min 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. • Total magnesium, with the exception of magnesium level > ULN – 3.0 mg/dL (1.23 mmol/L) associated with creatinine clearance ≥ 60 mL/min calculated using CKD-EPI formula. Mild decrease below LLN is acceptable at study entry if considered not clinically significant by Investigator. • 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 ≥ 60 mL/min 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 prior to the initiation of study treatment. • Women of childbearing potential (WOCBP) must have a negative serum (or urine) pregnancy test within 72 hours prior to enrolment. A positive urine pregnancy test result must immediately be confirmed using a serum test. A pregnancy test will have to be reported within 7 days prior to the first dose of the study treatment.
What rules you out
- 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 prior systemic treatment regardless of the timing.
- Life expectancy is less than nine weeks.
- Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the study treatment.
- Contraindication to MRI, CT or PET
- Unstable cardiac conditions (congestive heart failure, angina pectoris, myocardial infarction within one year before enrolment, uncontrolled hypertension, clinically significant arrhythmias)
- Psychological, familial, sociological, or geographical conditions could potentially hamper compliance with the study protocol and follow-up schedule.
- Known hypersensitivity to the active substance or to any excipients.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.