Trial Search Results
Efficacy and Safety of Lanreotide Autogel/ Depot 120 mg vs. Placebo in Subjects With Lung Neuroendocrine Tumours
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
- Drug: Best Supportive Care
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