A Phase IB Study of MPDL3280A and Erlotinib in Patients with Advanced Non-Small Cell Lung Cancer

Protocol
14-020
Full Title
A Phase 1b Study of the Safety and Pharmacology of MPDL3280A Administered with Erlotinib in Patients with Advanced Non-Small Cell Lung Cancer
Phase
I/II
Purpose

Most non-small cell lung cancers (NSCLC) treated with the standard therapy erlotinib (a drug used to treat cancers with a mutated form of the epidermal growth factor receptor, or EGFR) eventually come back or continue to grow despite this treatment. Researchers want to find out if adding the investigational drug MPDL3280A to erlotinib therapy might make treatment more effective.

One purpose of this study is to find the highest dose of MPDL3280A that can be given safely together with the standard dose of erlotinib in patients with advanced NSCLC that has not previously been treated with erlotinib or other EGFR inhibitors. A second goal is to assess the response to this combination.

MPDL3280A 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. MPDL3280A is given intravenously (by vein), while erlotinib 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, stage IV, or recurrent NSCLC.
  • Patients in the “expansion phase” of the study must have cancers that contain mutated EGFR.
  • Patients may not have previously received erlotinib or any other EGFR inhibitors.
  • At least 3 weeks must pass between completion of other therapies 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 open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Charles Rudin at 646-888-4527.

Disease(s)
Lung Cancer, Non-Small Cell
Locations