NCT06326190

177Lu-DOTATATE for Recurrent Meningioma

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recurrent Meningioma

Interventions

Type	Name	Description
DRUG	Local standard of Care	According to local standard practice, treatment or no treatment in the control arm is left to the investigator's discretion.
DRUG	177Lu-DOTATATE	Intravenous injection of 177Lu-DOTATATE

Timeline

• Start date: 2025-03-10
• Primary completion: 2027-04-14
• Completion: 2028-12-22
• First posted: 2024-03-22
• Last updated: 2025-09-16

Locations

12 sites across 5 countries: Austria, France, Norway, Spain, Switzerland