A Phase I Study of Immunotherapy with Atezolizumab plus Epacadostat in Patients with Previously Treated Stage IIIB or IV Non-Small Cell Lung Cancer

Full Title

A Phase 1 Study of Atezolizumab in Combination With Epacadostat in Subjects With Previously Treated Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Purpose

The purpose of this study is to find the highest doses of two immunotherapy drugs that can be given in combination in patients with stage IIIB or IV non-small cell lung cancer (NSCLC) that continues to grow despite prior treatment. The two drugs are atezolizumab and epacadostat. All patients will receive the same dose of atezolizumab; the researchers will evaluate various doses of epacadostat given in combination with atezolizumab to determine the highest dose that can be given safely.

Atezolizumab is designed to improve the immune system’s ability to recognize and destroy cancer cells by blocking PD-L1, a protein made by some cancers. Epacadostat is also designed to provoke an immune response against the cancer, but through its binding to an enzyme called IDO1.

Atezolizumab is approved for treating bladder cancer; its use in this study is considered investigational. It is given intravenously (by vein), while epacadostat 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 stage IIIB or IV NSCLC that has continued to grow despite chemotherapy that included a platinum-containing drug.
  • At least 3 weeks must pass since completion of prior chemotherapy and 2 weeks since any radiation therapy and entry into the study.
  • Patients who have previously received anti-PD-L1 or anti-IDO1 drugs may not participate.
  • 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

14-259

Phase

I

Investigator

Co-Investigators

Locations