Design of a Phase 3, International, Prospective, Randomized, Double-Blind, Placebo (PBO) Controlled Study Assessing Efficacy and Safety of Lanreotide Autogel/Depot (LAN) 120 mg in Patients with Well-Differentiated, Advanced Typical and Atypical Lung NETs Abstract #1504

Introduction: The international phase 3 CLARINET study showed that treatment with the somatostatin analog (SSA) lanreotide was associated with significantly prolonged PFS vs PBO in GEP-NETs, leading to a new indication approved in more than 35 countries. Like GEP-NETs, lung NETs express somatostatin receptors.
Aim(s): To evaluate antiproliferative effect of lanreotide in NETs of the lung.
Materials and methods: This multi-center study will enroll an anticipated 216 patients with typical/atypical metastatic and/or un-resectable lung NETs that have positive somatostatin imaging and who are treatment naïve or have had no more than 1 course of systemic chemotherapy (cytotoxic, molecular targeted therapy or interferon). Patients will be randomized 2:1 to receive monthly LAN 120 mg via deep subcutaneous injection plus best standard of care or PBO. An estimated 175 PFS events (disease progression or death) on both arms will provide a 90% power to detect a statistically significant treatment effect using a two-sided log rank test at a significance level of α=0.05.
Conference: 13th Annual ENETS conference 2016 (2016)
Category: ...none of the above
Presenting Author: George Camba
Keywords: Lung NETs, lanreotide

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