[¹⁷⁷Lu]Lu-DOTATATE for Recurrent Meningioma (LUMEN-1, EORTC-2334-BTG): Study Protocol for a Randomized Phase II Trial

Area of Science:

• Neuro-oncology
• Radiopharmaceutical therapy
• Clinical trials

Background:

• Recurrent meningioma lacks established treatment options post-surgery and radiotherapy.
• Somatostatin receptor type 2 (SSTR2) is highly expressed in meningiomas, indicating potential for targeted therapy.
• [177Lu]Lu-DOTATATE shows promise in small studies for meningioma treatment.

Purpose of the Study:

• To evaluate the efficacy and safety of [177Lu]Lu-DOTATATE in patients with recurrent meningioma.
• To compare [177Lu]Lu-DOTATATE against local standard of care in a randomized setting.
• To assess progression-free survival as the primary endpoint in this Phase II trial.

Main Methods:

• EORTC-2334-BTG (LUMEN-1) is a randomized, multicenter, Phase II trial.
• 136 patients with recurrent meningioma (WHO grade 1-3) will be randomized 2:1 to [177Lu]Lu-DOTATATE or standard of care.
• Eligibility includes SSTR2 positivity, measurable disease, and prior surgery/radiotherapy.

Main Results:

• Primary efficacy endpoint is locally assessed progression-free survival.
• Secondary endpoints include objective response rate, overall survival, safety, and quality of life.
• Exploratory translational research will investigate dosimetry and biomarkers.

Conclusions:

• LUMEN-1 is the first prospective randomized trial for [177Lu]Lu-DOTATATE in recurrent meningioma.
• Results will establish the efficacy of SSTR2-targeting radionuclide therapy in this patient population.
• The trial aims to provide a new therapeutic option for patients with limited treatment choices.