177Lu-DOTATATE for Recurrent Meningioma

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.

Timeline

Start

2025-03-10

Primary completion

2027-04-14

Completion

2028-12-22

Publications

• Albert NL, Tabouret E, Le Rhun E, Sahm F, Furtner J, Tonn JC, Alfano C, Silva JP, Govaerts AS, Gorlia T, Mirante O, Minniti G, Weller M, Preusser M; European Organisation for Research and Treatment of Cancer Brain Tumor Group. [177Lu]Lu-DOTATATE for Recurrent Meningioma (LUMEN-1, EORTC-2334-BTG): Study Protocol for a Randomized Phase II Trial. J Nucl Med. 2026 Jan 2;67(1):23-30. doi: 10.2967/jnumed.125.269633.

Drugs

Indications