Trial details

Trial short name: SPINET

Official 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 Tumor Control in Subjects With Well Differentiated, Metastatic and/or Unresectable, Typical or Atypical, Lung Neuroendocrine Tumors

Principal Investigator: Dr. Simron Singh

Cancer type: Neuroendocrine
Cancer location: Neuroendocrine
Disease stage: Advanced Cancer
Trial phase: Phase 3
Intervention: Drug: Lanreotide

Registration #: NCT02683941

Trial description:
The purpose of this study is to evaluate the effectiveness of the drug lanreotide in patients with lung neuroendocrine tumors. Patients with metastatic (the cancer has spread to other parts of the body) or unresectable (cannot be removed by surgery) neuroendocrine tumor to the lung many be able to participate. Patients may have had previous treatment, but not more than two lines of chemotherapy. There will be two groups of patients participating in this study; one group will receive the study drug lanreotide and best supportive care while the other group will receive a placebo and best supportive care. The patient, doctor and study staff will not know which group a patients is in. There will be an additional extension phase to this trial where all patients who were in the placebo group will then be able to receive the study drug lanreotide.

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 one course of cytotoxic chemotherapy or molecular targeted therapy or interferon for Lung NET