Efficacy and Safety of Lanreotide Autogel/ Depot 120 mg vs. Placebo in Subjects With Lung Neuroendocrine Tumours
Status:
Terminated
Trial end date:
2020-02-28
Target enrollment:
Participant gender:
Summary
This is a Phase 3, prospective, multi-center, randomized, double-blind, study evaluating the
efficacy and safety of LAN plus BSC versus placebo plus BSC for the treatment of
well-differentiated, metastatic and/or unresectable, typical or atypical lung NETs.
This study contains two phases: the Double-Blind (DB) Phase, and the Open Label (OL)
Extension Phase. The DB Phase includes: Screening, Baseline and Treatment period. The OL
Extension Phase will consist of two periods: Treatment Period and Follow-Up Period.
The primary objective will be to compare the antitumour efficacy of Lanreotide Autogel/Depot
120 mg (LAN) plus Best Supportive Care (BSC) every 28 days versus placebo plus BSC, in terms
of progression-free survival (PFS), measured by central review using Response Evaluation
Criteria in Solid Tumours (RECIST) v1.1 criteria, every 12 weeks, in subjects with
unresectable and/or metastatic well differentiated, typical or atypical lung neuroendocrine
tumours.
Recent updates of National Cancer Institute Cancer Network (NCCN) & European Neuroendocrine
Tumor Society (ENETS) guidelines recommend SSA in first line for the treatment of
locoregional unresectable or metastatic lung NETs as an option beyond
'observation''observation' leading to slow and difficult recruitment in SPINET study.
Consequently, it was decided to prematurely stop the recruitment in the SPINET study and to
transition all subjects still treated in the double-blind phase to the open label (OL)
extension following respective country approvals of Amendment #5.
The new aim of this Phase 3, multicenter, prospective, randomized placebo-controlled clinical
study is to describe the antitumor efficacy and safety of Lanreotide Autogel/Depot 120 mg
(LAN) plus Best Supportive Care (BSC) in subjects with well-differentiated, metastatic and/or
unresectable, typical or atypical, lung NETs.