Efficacy and Safety of Lanreotide Autogel/ Depot 120 mg vs. Placebo in Subjects With Lung Neuroendocrine Tumours

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Neuroendocrine Tumors in Lung

In brief

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.

Key facts

Study ID

NCT02683941

Run by

Ipsen

People needed

77

Starts

2017-03-06

Expected to finish

2020-02-28

Last updated by the study team

2022-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• VA Greater Los Angeles — Los Angeles, California, United States
• Rocky Mountain Cancer Center — Denver, Colorado, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• Dana-Farber Institute — Boston, Massachusetts, United States
• Karmanos Cancer Center — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Roswell Park Cancer Center — Buffalo, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Oregon Health and Science Center — Portland, Oregon, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Texas Oncology — Dallas, Texas, United States
• Texas Oncology-Forth Worth — Fort Worth, Texas, United States
• AKH und Med. University Vienna Allg Krankenhaus Wien — Vienna, Austria
• Klinikum Wels-Grieskirchen GmbH — Wels, Austria
• Tom Baker Cancer Center — Calgary, Alberta, Canada
• QEII Health Sciences Centre — Halifax, Nova Scotia, Canada
• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada
• McGill University Health Center — Montreal, Quebec, Canada
• Saskatoon Cancer Centre — Saskatoon, Canada
• Cancer Care of Manitoba — Winnipeg, Canada
• Aarhus University Hospital — Aarhus, Denmark
• NET-Centre, Rigshospitalet — Copenhagen, Denmark
• Centre Oscar Lambret — Lille, France
• Arizona Oncology Associates — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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