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Clinical Trial VICCTHO15115

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

Principal Investigator(s)

Sally York

Details

  • Protocol No. VICCTHO15115
  • Open Date: 11/08/2016
  • Staging: Phase III
  • Age Group: Adults
  • Scope: International
  • Objective: To compare the antitumour efficacy of LAN plus BSC every 28 days monotherapy 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.
  • Disease Sites: Lung; Neuroendocrine
  • Therapies: Molecular Targeted Agents / Immunotherapy / Biologics; Supportive Care
  • Drugs: Blinded Drug; Lanreotide Autogel/Depot
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT02683941
  • Secondary Protocol No: A-US-52030-328

Description

Participants have been asked to participate in this study because they have a neuroendocrine tumor (NET) of the lungs. Although rare, NET have increased over the past 30 years and surgery is the current treatment of choice. There are limited options for NET that are metastatic (have spread to other parts of the body) or cannot be surgically removed. The main goal for NET that cannot be removed is to treat the symptoms associated with these tumors, and to prevent the NET from progressing. The purpose of this research study is to evaluate effectiveness and safety of the study drug, lanreotide, for treating neuroendocrine tumors of the lungs. In this study, lanreotide will be compared with placebo treatment (i.e. dummy treatment that looks like the real treatment but contains no active ingredient).

Eligibility

Ages Eligible for Study:18 Years and older
Genders Eligible for Study:All
Accepts Healthy Volunteers:No

Criteria

Inclusion Criteria:
• Have metastatic and/or unresectable pathologically confirmed well-differentiated, typical or atypical neuroendocrine tumor of the lung
• Histologic evidence of Well differentiated Neuroendocrine tumors (NETs) of the lung (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 lung origin are excluded
• Has been treated with an Somatostatin analogs (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 Lung NET