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Poster Display session (Friday) (ID 65)
- Event: ELCC 2018
- Type: Poster Display session
- Presentations: 1
- Coordinates: 4/13/2018, 12:30 - 13:00, Hall 1
232TiP - Lanreotide autogel/depot in lung neuroendocrine tumours: The randomized, double-blind, placebo-controlled, international phase 3 SPINET Study (ID 600)
12:30 - 13:00 | Author(s): D. Hoersch
Treatment options for advanced lung neuroendocrine tumours (NETs) are limited. The phase 3 CLARINET study demonstrated antitumour efficacy of the somatostatin analogue (SSA) lanreotide autogel/depot (LAN) 120 mg/28 days vs. placebo for metastatic gastroenteropancreatic grade 1/2 (Ki-67 < 10%) NETs, but prospective data on SSAs in advanced lung NETs are lacking. This study evaluates antitumour efficacy and safety of LAN 120 mg in patients with advanced lung NETs.
SPINET is a large double-blind, placebo-controlled phase 3 study. Main inclusion criteria are adults with well-differentiated typical/atypical, metastatic and/or unresectable lung NETs, at least one measurable lesion on CT/MRI imaging (RECIST v1.1), positive somatostatin receptor imaging, ECOG PS0–1. Patients have a maximum of two previous courses of cytotoxic chemotherapy, molecular-targeted therapy or interferon. A total of 216 patients from 80 sites across the USA, Canada and Europe will be randomized 2:1 to either LAN 120 mg/28 days or placebo, both with best supportive care, until progressive disease (PD)/death or unacceptable toxicity. Patients experiencing PD on placebo may opt to receive LAN 120 mg in an open-label extension. All patients experiencing PD will be followed to document survival, quality-of-life (QoL) and subsequent treatment. Recruitment began in July 2016. The primary endpoint is progression-free survival (PFS, time from randomization to PD/death; central review, RECIST v1.1). Main secondary endpoints include, objective response rate, overall survival, time to treatment failure, change in chromogranin A, QoL, and safety. SPINET is the first prospective randomized trial designed to assess LAN 120 mg in typical/atypical carcinoid lung NETs.
Clinical trial identification:
NCT02683941; EudraCT: 2015-004992-62
Legal entity responsible for the study:
X-M. Truong Thanh, A. Houchard: Employee of Ipsen. D. Reidy-Lagunes: Honoraria from Novartis; Consultancy and speakers’ bureau fees from Ipsen, Novartis, and Pfizer; Research funding from Novartis. M. Kulke: Consultancy fees from Ipsen, and Novartis. E. Wolin: Consultancy and advisory fees from Ipsen, and Advanced Accelerator applications. D. Ferone: Renumeration for services from Novartis, Ipsen, and Pfizer. D. Hoersch: Fees from Lexicon; Grants, personal fees and other from Novartis, Ipsen, and Pfizer. M. Caplin: Honoraria, consultancy and speakers’ bureau fees from Ipsen, Advanced Accelerator Applications, and Novartis. E. Baudin: Remuneration for services (advisory board or board of directors; corporate-sponsored research; consulting fee; research investigator; speaker) from Ipsen, Novartis, Pfizer, and Advanced Accelerator Applications. All other authors have declared no conflicts of interest.
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