A Phase 3 Prospective, Randomized, Double-Blind, Multi-Center, Phase 2 Study of the Efficacy and Safety of Lanreotide Autogel/ Depot 120 mg plus BSC vs. Placebo for Tumor Control in Patients with well Differentiated, Advanced Lung or Thymus Neuroendocrine Tumors (SPINET)
ID Number 16-2490Principal Investigator(s)
Michelle K Kim
Department(s) or Division(s)
The purpose of this study is to ascertain the role of Lanreotide Autogel/Depot plus BSC in the management of advanced or metastatic lung or thymus neuroendocrine tumors (NETs). There have been very limited data in this patient setting, except for sub-analyses of larger randomized studies; but there is a clear molecular rationale that establishes the potential role of SSAs like Lanreotide Autogel/Depot plus BSC in advanced lung/thymus NETs.
Subjects may qualify to take part in this research study because they have been diagnosed with well differentiated, advanced or metastatic lung or thymus NETs.
Subjects will be screened and undergo a series of tests to determine if they are eligible for the study.
During the study drug treatment period, subjects will either receive Lanreotide Autogel/Depot 120 mg or placebo.
The randomization method is set up so the subject has an equal chance of receiving the study drug or receiving placebo; therefore, they have a 50% chance of receiving Lanreotide Autogel/Depot and a 50% chance of receiving placebo.
Their participation in this research study is expected to last a maximum of 2 years.
The number of people expected to take part in this research study at this site is 10. The total number of people expected to take part in this research study is 126.
Recruiting Patients: Yes