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

Nathalie L. Albert, Emeline Tabouret, Emilie Le Rhun, Felix Sahm, Julia Furtner, Joerg-Christian Tonn, Christian Alfano, José Pais Silva, Anne-Sophie Govaerts, Thierry Gorlia, Osvaldo Mirante, Giuseppe Minniti, Michael Weller, Matthias Preusser
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Abstract

There are no established treatment options for patients with meningioma recurring after surgery and radiotherapy. Somatostatin receptor type 2 (SSTR2) is highly expressed in meningiomas, and SSTR2-targeting radionuclide therapy with [177Lu]Lu-DOTATATE has shown potential activity in the treatment of meningioma in uncontrolled and small studies. Methods: EORTC-2334-BTG (LUMEN-1, NCT06326190) is a randomized, multicenter, phase II trial in patients with recurrent World Health Organization (WHO) grade 1, 2, or 3 meningioma. In total, 136 patients will be randomized in a 2:1 ratio to [177Lu]Lu-DOTATATE (≤4 doses of 7.4 GBq given every 4 wk) or local standard of care (hydroxyurea, bevacizumab, sunitinib, octreotide, everolimus, or observation). The main eligibility criteria include age 18 y or older; neuropathologically confirmed meningioma of WHO grade 1, 2, or 3; WHO performance score of 0–2; measurable disease on MRI (≥10 x 10 mm); radiologically documented progression of any existing tumor (growth > 25% or new lesions) or appearance of new lesions within the last 2 y; SSTR positivity by PET imaging (SUVmax > 2.3); at least 1 prior surgery and at least 1 line of radiotherapy; and no prior systemic therapy. The primary efficacy endpoint is locally assessed progression-free survival according to Response Assessment in Neuro-Oncology MRI meningioma criteria, and secondary endpoints include radiologic response rate, overall survival, safety, health-related quality of life, and neurologic function. The trial protocol includes a comprehensive exploratory translational research program with dosimetry and imaging-based and tissue-based investigations. LUMEN-1 was activated in March 2025 and will enroll patients in 35 sites in 10 countries across Europe, with primary endpoint collection planned after 2 y and study completion after 5 y. To our knowledge, EORTC-2334-BTG (LUMEN-1, NCT06326190) is the first prospective randomized trial investigating the efficacy of [177Lu]Lu-DOTATATE in patients with recurrent meningioma.

[177]Lu-DOTATATE治疗复发性脑膜瘤(LUMEN-1, EORTC-2334-BTG):随机II期临床研究方案
对于手术和放疗后复发的脑膜瘤患者,没有确定的治疗方案。生长抑素受体2型(SSTR2)在脑膜瘤中高表达,[177Lu]Lu-DOTATATE靶向SSTR2的放射性核素治疗在非对照和小型研究中显示出治疗脑膜瘤的潜在活性。方法:EORTC-2334-BTG (LUMEN-1, NCT06326190)是一项随机、多中心、II期试验,在复发的世界卫生组织(WHO) 1、2或3级脑膜瘤患者中进行。总共有136名患者将以2:1的比例随机分配至[177Lu]Lu-DOTATATE(每4周给药4次,剂量为7.4 GBq)或当地标准护理(羟基脲、贝伐单抗、舒尼替尼、奥曲肽、依维莫司或观察)。主要资格标准包括年满18岁;经神经病理学证实为WHO 1级、2级或3级脑膜瘤;WHO绩效评分0分;2分;MRI可测量病变(10 × 10 mm);影像学记录的任何现有肿瘤进展(生长>;25%或新病灶)或在过去2年内出现新病灶;PET显像SSTR阳性(SUVmax >;2.3);既往至少一次手术和至少一次放疗;之前也没有接受过全身治疗。主要疗效终点是根据神经肿瘤学MRI脑膜瘤标准的反应评估局部评估无进展生存期,次要终点包括放射学反应率、总生存期、安全性、健康相关生活质量和神经功能。试验方案包括一项全面的探索性转化研究计划,包括剂量学、基于成像和基于组织的调查。LUMEN-1于2025年3月启动,将在欧洲10个国家的35个地点招募患者,主要终点计划在2年后收集,5年后完成研究。据我们所知,EORTC-2334-BTG (LUMEN-1, NCT06326190)是首个调查[177Lu]Lu-DOTATATE对复发性脑膜瘤患者疗效的前瞻性随机试验。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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