A Phase II Study of MPDL3280A in Patients with PD-L1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Protocol
13-084
Full Title
A Phase II, Multicenter, Single-Arm Study of MPDL3280A in Patients with PD-L1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Phase
II
Purpose

Many non-small cell lung cancers (NSCLC) fail to respond to standard therapies, or they return despite these treatments. Researchers are therefore seeking more effective treatments. The purpose of this study is to assess the safety and effectiveness of an investigational drug called MPDL3280A in patients with locally advanced or metastatic NSCLC.

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. Patients in this study must have NSCLC tumors that express PD-L1. MPDL3280A 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 locally advanced (stage IIIB), metastatic (stage IV), or recurrent NSCLC.
  • A new tumor biopsy is required for entering the study, and patients must have tumors that are PD-L1-positive to be eligible.
  • For patients whose tumors contain mutations in the EGFR gene or rearrangement of the ALK genes, the tumor must have progressed on prior treatment with erlotinib or crizotinib, respectively, and progressed on prior chemotherapy.
  • Patients may not have previously received immunotherapy for NSCLC.
  • 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. Naiyer Rizvi at 646-888-4204.

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