SPINET

• Research type

  Research Study

• Full title

  A Phase 3, prospective, randomized, double-blind, multi-center study of the efficacy and safety of lanreotide Autogel/Depot 120 mg plus BSC vs. placebo plus BSC for tumor control in subjects with well differentiated, metastatic and/or unresectable, typical or atypical, lung neuroendocrine tumors.

• IRAS ID

  200691

• Contact email

  regulatory@theradex.co.uk

• Sponsor organisation

  Ipsen Biopharmaceuticals, Inc.

• Eudract number

  2015-004992-62

• Clinicaltrials.gov Identifier

  NCT02683941

• Duration of Study in the UK

  3 years, 2 months, 31 days

• Research 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.

  Patient participation in this study could last around 2 years and include approximately 12 study visits. Patients will also be asked to come back to the hospital for the study drug injection every 28 days. The clinical study consists of two phases:
  1) a double-blind phase and
  2) an open-label extension phase
  In the double-blind phase neither the patient nor the doctor will know if the patient is receiving the study drug or placebo. In the open-label extension phase, the patient will either receive Lanreotide if he agrees and if he complies with the entry criteria, or the patient will be followed up for quality of life and survival.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  16/LO/1589

• Date of REC Opinion

  14 Nov 2016

• REC opinion

  Further Information Favourable Opinion