CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 136 target
Drug / intervention
Local standard of Care +1 moredrug
Likely dose
Not stated in record
Key inclusion· 17
  • ✓Adult age ≥18 years
  • ✓Histologically confirmed meningioma all grades 1-3 per WHO CNS5
  • ✓WHO performance status 0-2
  • ✓Measurable disease: ≥10×10 mm contrast-enhancing lesion on MRI within 2 weeks of randomization
Key exclusion· 9
  • ✕Local therapy (surgery and/or radiotherapy) indicated per investigator; exception: after local therapy with 4-week gap if ≥1 remaining lesion meets inclusion criteria
  • ✕Any prior systemic treatment regardless of timing
  • ✕Life expectancy <9 weeks
  • ✕History of other invasive malignancy within 5 years (except non-melanoma skin cancer, localized low-risk prostate cancer, adequately treated CIN)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT06326190Phase 2RecruitingHigh Momentum
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177Lu-DOTATATE for Recurrent Meningioma: a Randomized Phase II Study

European Organisation for Research and Treatment of Cancer - EORTC·interventional·Posted Mar 22, 2024·Updated Jun 15, 2026

In Brief

A Phase 2 clinical trial evaluating Local standard of Care and 177Lu-DOTATATE for Recurrent Meningioma. Currently recruiting, targeting 136 participants across 19 sites in 6 countries.

Signals

Enrolling ahead of pace

Detailed 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. 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRecurrent Meningioma
CountriesAustria, France, Germany, Norway, Spain, Switzerland
CollaboratorsNovartis

Timeline

Phase 2Recruiting
20252026202720282029
First PostedMar 22, 2024
Enrollment StartMar 10, 2025
Primary CompletionApr 14, 2027
Study CompletionDec 22, 2028
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 2.3 years agoPrimary completion in 9 months

Arms & Interventions

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)

Drug: Local standard of Care
Experimental group: 177Lu-DOTATATEexperimental

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

Drug: 177Lu-DOTATATE

Interventions

Local standard of Caredrug

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

177Lu-DOTATATEdrug

Intravenous injection of 177Lu-DOTATATE