Lanreotide Autogel/Depot (LAN) in Lung Neuroendocrine Tumours (NETs): The Randomized, Double-Blind, Placebo (PBO)-Controlled, International Phase 3 SPINET Study
Introduction: Treatment options for advanced lung NETs are limited. The phase 3 CLARINET study demonstrated antitumour efficacy of somatostatin analogue (SSA) LAN 120mg vs PBO for metastatic gastroenteropancreatic grade 1/2 (Ki-67<10%) NETs, but prospective data on SSAs in advanced lung NETs are lacking.
Aim(s): This study evaluates safety and antitumour efficacy of LAN 120mg in pts with advanced lung NETs.
Materials and methods: SPINET is a large double-blind, PBO-controlled phase 3 study (NCT02683941; EudraCT: 2015-004992-62). Main inclusion criteria are adults with well-differentiated typical/atypical, metastatic and/or unresectable lung NETs, positive SSTR imaging, ≤1 chemotherapy course, ECOG PS0–1. 216 pts from 80 sites across the USA, Canada and Europe will be randomized 2:1 to either LAN 120mg/28 days or PBO, both with best supportive care, until PD/death or unacceptable toxicity. Pts experiencing PD on PBO may opt to receive LAN 120mg in an open-label extension. All pts experiencing PD will be followed to document survival, QoL and subsequent treatment. Recruitment began in July 2016.
Conference: 14th Annual ENETSConcerence (2017)
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