Efficacy and Safety of Lanreotide Autogel/ Depot 120 mg vs. Placebo in Subjects With Lung Neuroendocrine Tumours
Condition: Neuroendocrine Tumors in Lung
MeSH terms: Neuroendocrine Tumors
Intervention: Lanreotide (Autogel formulation); Placebo; Best Supportive Care
Intervention description: 120mg every 28 days until disease progression, death, or unacceptable toxicity; Saline solution 0.9% administered via deep subcutaneous injection every 28 days until disease progression.; Best Supportive Care is best available therapy at the choice of the investigator
Intervention MeSH terms: Lanreotide; Somatostatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 77.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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