ECEESPE2025 ePoster Presentations Endocrine Related Cancer (100 abstracts)
177Lu-edotreotide versus everolimus in patients with advanced neuroendocrine tumors of lung or thymic origin: progress of the LEVEL / GETNE-t2217 trial
Jaume Capdevila 1 , Alejandro García-Álvarez 1 , Jorge Hernando 1 , Alice Durand 2 , Urbano Anido 3 , Eric Baudin 4 , Rocio Garcia-Carbonero 5 , Javier Molina-Cerrillo 6 , Maribel del Olmo-García 7 , Paula Jimenez-Fonseca 8 , Catherine Ansquer 9 , Come Lepage 10 , Marta Benavent Viñuales 11 , Jose Carlos Ruffinelli 12 , Amandine Beron 13 , Magalie Haissaguerre 14 , Emmanuel Deshayes 15 , David Taieb 16 , Maddalena Sansovini 17 , Virginia Pubul 3 , Nicola Fazio 18 & Thomas Walter 19
1Department of Medical Oncology, Gastrointestinal and Endocrine Tumor Unit, Vall d’Hebron Hospital Universitari, Vall d’Hebron Barcelona Hospital Campus, Neuroendocrine and Endocrine Tumor Translational Research Program (NET-VHIO), Vall Hebron Institute of Oncology (VHIO), Vall d’Hebron Barcelona Hospital Campus, Barcelona, Spain; 2Medical Oncology Department. Edouard Herriot Hospital, Lyon, Spain; 3Molecular Imaging Research Group, Nuclear Medicine Department. University Clinical Hospital of Santiago de Compostela, Santiago de Compostela, Spain; 4Imaging Oncology Department, Endocrine Unit. Institute Gustave Roussy, Paris, France; 5Medical Oncology Department. Hospital Universitario 12 de Octubre, Imas12, UCM, Madrid, Spain; 6Medical Oncology Department, Hospital Universitario Ramón y Cajal, Madrid, Spain; 7Endocrinology and Nutrition Department, University and Polytechnic Hospital La Fe, Valencia, Spain; 8Medical Oncology Department. Hospital Universitario Central de Asturias, ISPA, Oviedo, Spain; 9Nuclear Medicine Department. Centre Hospitalier Universitaire de Nantes, Nantes, Spain; 10Medical Oncology Department. Hospital Center University Dijon-Bourgogne, Dijon, Spain; 11Medical Oncology Department, University Hospital Virgen del Rocío, Instituto de Biomedicina de Sevilla (IBIS), Seville, Spain; 12Medical Oncology Department. Institut Català d’Oncologia (ICO) - IDIBELL, L’Hospitalet del Llobregat, Spain; 13Medical Oncology Department. Lille University Hospital, Lille, France; 14Medical Endocrinology and Endocrine Oncology Department. Centre Hospitalier Universitaire (CHU) Bordeaux, Haut Leveque Hospital, Pessac, France; 15Nuclear Medicine Department. Institut régional du Cancer de Montpellier - ICM Val d’Aurelle, Montpellier, France; 16Nuclear Medicine Department. La Timone University Hospital, CERIMED, Aix-Marseille University, Marseille, Spain; 17Medical Oncology Department. IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - Irsì, Meldola, Spain; 18Division of Gastrointestinal Medical Oncology and Neuroendocrine Tumor, Istituto Europeo di Oncologia (IEO), IRCCS, Milan, Italy; 19Medical Oncology Department. Edouard Herriot Hospital, Lyon, France
JOINT1067
Background: Peptide receptor radionuclide therapy (PRRT) has shown promising activity in somatostatin receptor (SSTR)-positive lung neuroendocrine tumors (NETs) in retrospective series. This study aims to compare the efficacy, safety, and patient-reported outcomes of 177Lu-edotreotide versus the standard of care everolimus in patients with advanced lung and thymic NETs.
Methods: The LEVEL trial is a randomized, open-label, phase 3 international (France, Italy, Belgium, and Spain) trial evaluating 177Lu-edotreotide versus everolimus in patients with progressive, advanced, and well/moderately differentiated NETs of lung (typical/atypical) or thymic origin. Patients could be treatment naïve or have progressed (PD) on somatostatin analogues or up to 2 additional systemic treatments. Prior PRRT or mTOR inhibitors are not permitted. Eligible patients are randomly assigned 3:2 to 177Lu-edotreotide or everolimus. 177Lu-edotreotide is administered intravenously at a total dose of 7.5±0.7 GBq per cycle for up to 6 cycles, with a 6-week interval between cycles 1 and 2 and a 8-week interval between cycles afterwards. Everolimus is administered orally 10 mg once daily until PD or unacceptable toxicity. CT or MRI scans are performed every 12 weeks until PD. Blood samples are analyzed at baseline, at 1st tumor assessment, and at PD for pharmacodynamic endpoints. Archival tumor tissue samples will be analyzed for ancillary studies. The primary endpoint is progression-free survival (PFS) according to RECIST v1.1. Secondary endpoints include overall response rate, overall survival, safety, and quality of life (EORTC QLQ-C30). The planned sample size is 120 patients using a two-sided Lan-DeMets with O’Brian-Fleming-like boundaries test to demonstrate a statistical significant reduction of PFS hazard ratio of 0.536 in favor of 177Lu-edotreotide (α=0.05, β=0.2). The study includes an interim analysis after 60 PFS events are observed. The final analysis will be conducted after 87 PFS events. Recruitment started in Oct 2023. The study is active in all four countries. Currently, 57 patients have been randomized, and three more patients are in screening. Completion of recruitment is expected by the end of 2025. Clinical trial identification: EU CT: 2022-502154-13-00 / NCT05918302
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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