A Phase III Study of Immunotherapy with Nivolumab, Nivolumab/Ipilimumab, or Placebo as Maintenance Therapy in Patients with Extensive-Stage Disease Small Cell Lung Cancer

Full Title

A Randomized, Multicenter, Double-Blind, Phase 3 Study of Nivolumab, Nivolumab in Combination with Ipilimumab, or Placebo as Maintenance Therapy in Subjects with Extensive- Stage Disease Small Cell Lung Cancer (ED-SCLC) after Completion of Platinum-based First Line Chemotherapy

Purpose

Nivolumab is a drug approved for the treatment of several types of cancer, including some types of non-small cell lung cancer. It is a type of immunotherapy. In this study, researchers want to see if using nivolumab alone or in combination with another immunotherapy called ipilimumab is effective as maintenance therapy in patients with extensive-stage disease small cell lung cancer, to see if it can control cancer growth after four cycles of platinum-based chemotherapy.

Nivolumab boosts the body's immune system by targeting a protein on white blood cells called PD-1. PD-1 normally maintains the balance of the immune system by shutting it down at the right time. Some cancers take advantage of this mechanism by expressing PD-L1, enabling them to escape attack by the body's white blood cells. Nivolumab blocks PD-1, enhancing the body's ability to detect and destroy cancer cells.

Ipilimumab is an antibody against CTLA-4, a molecule that controls a part of the immune system by shutting it down at the right time. Ipilimumab is already approved for treating melanoma, alone and in combination with nivolumab. The use of nivolumab and ipilimumab together for treating lung cancer is considered investigational.

In this study, patients will be randomly assigned to receive nivolumab alone, nivolumab plus ipilimumab, or a placebo (inactive drug). All treatments are given intravenously (by vein). Patients' doctors will not know which treatment they are receiving.

Eligibility

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

  • Patients must have been diagnosed with stage IV small cell lung cancer that shrank or stopped growing following the first four cycles of platinum-based chemotherapy. Patients may not receive more than four cycles of chemotherapy.
  • Patients may not have had prior immunotherapies that targeted PD-1 or CTLA-4.
  • 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 patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Jamie Chaft at 646-888-4545.

Protocol

15-303

Phase

III

Investigator

Co-Investigators

Locations