Trial Search Results

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

The purpose of this study is to assess the median progression-free survival (PFS)of patients with well differentiated, metastatic and/or unresectable typical or atypical lung neuroendocrine tumors treated with Lanreotide Autogel/Depot plus BSC versus placebo plus BSC.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Ipsen

Stanford Investigator(s):

Intervention(s):

  • Drug: Lanreotide (Autogel formulation)
  • Drug: Placebo

Phase:

Phase 3

Eligibility


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

   - 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 Lung NET

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting