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

#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 ENETSConcerence (2016)

Presenting Author: Reidy-Lagunes D

Authors: Reidy-Lagunes D, Kulke M, Wolin E, Mirakhur B, Massien C,

Keywords: Lung NETs, lanreotide,