A Phase III Study of Lanreotide Autogel/Depot versus Placebo in Patients with Metastatic or Inoperable Lung Neuroendocrine Tumors

Full 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 (SPINET)

Purpose

Neuroendocrine tumors of the lung that has spread or cannot be surgically removed are challenging to treat. Lanreotide autogel is a drug already used to treat neuroendocrine tumors. It is a manmade form of the hormone somatostatin.

In this study, researchers are evaluating a form of this drug called lanreotide autogel/depot that is given once a month as a subcutaneous (under the skin) injection and lasts longer in the patient's body. They are assessing this drug in patients with metastatic or inoperable lung neuroendocrine tumors.

Patients will be randomly assigned to receive lanreotide autogel/depot or a placebo. Both groups will also receive best supportive care.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a well-differentiated metastatic or inoperable neuroendocrine tumor of the lung.
  • Patients may have had up to one prior chemotherapy regimen and it must have been completed at least 4 weeks before entering the study. Any prior surgery or local therapies (such as embolization) must have been performed more than 6 weeks before study entry.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for men age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Diane Reidy-Lagunes at 646-888-4185.

Protocol

16-351

Phase

III

Investigator

Co-Investigators

Diseases

Locations