A Phase III Study of Nivolumab Immunotherapy versus Observation After Surgery for Non-Small Cell Lung Cancer

Full Title

A Randomized Phase III Study of Nivolumab After Surgical Resection and Adjuvant Chemotherapy in Non-Small Cell Lung Cancers [Adjuvant Nivolumab in Resected Lung Cancers (ANVIL) (ECOG, EA5142) (CIRB)

Purpose

Nivolumab is an immunotherapy drug approved to treat some non-small cell lung cancers (NSCLC) that has continued to grow despite chemotherapy. In this study, researchers want to see if nivolumab is effective for preventing lung cancer growth in patients with early-stage NSCLC that has been surgically removed. Patients will be randomly assigned to receive nivolumab or observation after NSCLC 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 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. It 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 stage IB (greater than 4 cm), II, or IIIA NSCLC that has been surgically removed.
  • At least 4 weeks must pass since major surgery and entry into the study. For patients who had chemotherapy after surgery, at least 2 weeks must pass before entering the study; at least 4 weeks must pass since the completion of any radiation therapy.
  • 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

16-867

Phase

III

Investigator

Co-Investigators