A Phase II Study of Nivolumab Immunotherapy Alone and with Other Anticancer Drugs for Advanced Non-Small Cell Lung Cancer

Full Title

A Phase 2, Fast Real-time Assessment of Combination Therapies in Immuno-Oncology Study in Subjects with Advanced Non-small Cell Lung Cancer (FRACTION-Lung)

Purpose

Nivolumab is an immunotherapy drug used to treat some non-small cell lung cancers (NSCLC) as well as other types of cancer. It 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.

Researchers want to know if combining nivolumab with other anticancer drugs is more effective than nivolumab alone for treating advanced NSCLC. In this study, patients will receive nivolumab alone, nivolumab plus dasatinib (a drug used to treat leukemia), or nivolumab plus BMS-986016 (another immunotherapy drug, which boosts the immune response against cancer by targeting a protein called LAG-3). Nivolumab and BMS-986016 are given intravenously (by vein), and dasatinib is taken orally (by mouth).

Eligibility

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

  • Patients must have inoperable or metastatic NSCLC.
  • Prior treatment is permitted. At least 4 weeks must pass since the completion of chemotherapy and/or radiation therapy and entry into the study.
  • 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. Matthew Hellmann at 646-888-4863.

Protocol

16-1106

Phase

II

Investigator

Co-Investigators

Locations