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NCT02683941 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Lanreotide Autogel/ Depot 120 mg vs. Placebo in Subjects With Lung Neuroendocrine Tumours
A Phase 3 study, sponsored by Ipsen.
- Terminated
- Registry status
- Phase 3
- Development phase
- 77
- Enrollment target
NCT02683941: Clinical Trial Phase 3 study, sponsored by Ipsen.
NCT02683941 is a Phase 3 study that was terminated before completion, run by Ipsen. The registered enrollment target is 77 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02683941, a Phase 3 study, was terminated before completion, sponsored by Ipsen.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 77 participants
- Enrollment target
Study 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 bronchopulmonary NETs. This study contains two phases: the Double-Blind (DB) Phase, and the Open Label (OL) Phase. The DB Phase includes: Screening, Baseline and Treatment period. The OL Phase will consist of two periods: Treatment Period and Follow-Up Period. The primary objective will be to describe the antitumour efficacy of Lanreotide Autogel/Depot 120 mg (LAN) plus Best Supportive Care (BSC) every 28 days, 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 randomized to LAN with unresectable and/or metastatic well differentiated, typical or atypical bronchopulmonary 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 bronchopulmonary NETs as an option beyond '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) treatment and follow-up phases 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, bronchopulmonary NETs.
Primary Outcome
PFS for subjects randomised in the lanreotide group, assessed by central review using Response Evaluation Criteria In Solid Tumours Version 1.1 (RECIST v1.1) criteria every 12 weeks, defined as the time from randomisation to disease progression or death from any causes during either the double-blind phase, or the open-label treatment phase. The distribution of PFS times were estimated using the Kaplan-Meier product limit method.
Interventions
- DRUG Placebo
- DRUG Lanreotide (Autogel formulation)
- DRUG Best Supportive Care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2017-03-06 |
| Est. Completion | 2020-02-28 |
| Phase | Phase 3 |
Why NCT02683941 stopped before completion
NCT02683941 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02683941 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02683941 about?
NCT02683941 is a clinical study titled "Efficacy and Safety of Lanreotide Autogel/ Depot 120 mg vs. Placebo in Subjects With Lung Neuroendocrine Tumours". 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 bronchopulmonary NETs. This study contains two phase...
What is the current status of trial NCT02683941?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 77 participants. The study started on 2017-03-06. Estimated completion is 2020-02-28.
What interventions are being tested in trial NCT02683941?
The interventions under investigation include: Placebo (DRUG), Lanreotide (Autogel formulation) (DRUG), Best Supportive Care (DRUG).
Who is sponsoring clinical trial NCT02683941?
This trial is sponsored by Ipsen, which has 85 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02683941's enrollment target sits among peer trials
77 1771st of 2000 higher than 228 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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