177Lu-DOTATATE for Recurrent Meningioma — LUMEN-1  

Recurrent Meningioma Clinical Trial

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

Status Not yet recruiting

Clinical 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. 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Meningioma
• Recurrence
• Recurrent Meningioma

• NCT number: NCT06326190
• Study type: Interventional
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: EORTC
• Phone: +32 2 774 16 11
• Email: eortc@eortc.org
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: November 6, 2024
• Completion date: December 22, 2028