A Phase II Study of Preoperative Nivolumab Immunotherapy to Treat Operable Non-Small Cell Lung Cancer

Full Title

Neoadjuvant Anti-Programmed Death-1 Antibody, Nivolumab, in Resectable Non-Small-Cell Lung Cancer

Purpose

An immunotherapy called nivolumab can shrink tumors in some patients with advanced non-small cell lung cancer (NSCLC). The purpose of this study is to evaluate the safety and effectiveness of giving the drug nivolumab to patients with operable NSCLC before they have surgery.

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 shut-down mechanism by activating PD-1, enabling them to escape attack by the body's white blood cells.

Nivolumab binds to and inactivates PD-1, enhancing the body's ability to detect and destroy cancer cells. It is approved for treating several types of cancer; its use in this study is considered investigational. Nivolumab is given intravenously (by vein).

Eligibility

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

  • Patients must have previously untreated NSCLC that will be surgically removed.
  • Patients may not have any history of an autoimmune condition or interstitial lung disease.
  • 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

15-106

Phase

Pilot

Investigator

Co-Investigators

Locations