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Efficacy and Safety of Lanreotide Autogel/ Depot 120 mg vs. Placebo in Subjects With Lung Neuroendocrine Tumours
Not Recruiting
Trial ID: NCT02683941
Purpose
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.
Official 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 Tumour Control in Subjects With Well Differentiated, Metastatic and/or Unresectable, Typical or Atypical, Lung Neuroendocrine Tumours
Stanford Investigator(s)
George A. Fisher Jr.
Colleen Haas Chair in the School of Medicine
Eligibility
Inclusion Criteria:
- Have metastatic and/or unresectable pathologically confirmed well-differentiated,
typical or atypical neuroendocrine tumor of the bronchopulmonary
- Histologic evidence of Well differentiated Neuroendocrine tumors (NETs) of the
bronchopulmonary (typical and atypical according to the World Health Organisation (WHO
criteria), evaluated locally)
- Has a mitotic index <2 mitoses/2 mm2 for typical carcinoid (TC) and <10 mitoses/2 mm2
and/or foci of necrosis for atypical carcinoid (AC)
- At least one measurable lesion of the disease on imaging (CT or MRI; RECIST 1.1)
- Positive Somatostatin receptors (SSTR) imaging
Exclusion Criteria:
- Poorly differentiated or high grade carcinoma, or patients with neuroendocrine tumors
not of bronchopulmonary origin
- Has been treated with a Somatostatin analog (SSA) at any time prior to randomization,
except if that treatment was for less than 15 days (e.g. peri-operatively) of short
acting SSA or one dose of long acting SSA and the treatment was received more than 6
weeks prior to randomization
- Has been treated with Peptide receptor radionuclide therapy (PRRT) at any time prior
to randomization
- Has been treated with more than two lines of cytotoxic chemotherapy or molecular
targeted therapy or interferon for bronchopulmonary NET
Intervention(s):
drug: Lanreotide (Autogel formulation)
drug: Placebo
drug: Best Supportive Care
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061