A Phase II Study of MEDI4736 in Patients with Stage IIIB-IV Non-Small Cell Lung Cancer Containing the PD-L1 Protein

Protocol
14-103
Full Title
A Phase II, Non-comparative, Open label, Multi-centre, International Study of MEDI4736, in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV) who have received at least Two Prior Systemic Treatment Regimens Including One Platinum-based Chemotherapy Regimen (ATLANTIC)
Phase
II
Purpose

The purpose of this study is to evaluate the safety and effectiveness of the investigational drug MEDI4736 in patients with stage IIIB or IV non-small cell lung cancer (NSCLC) that has continued to grow despite at least two prior regimens of therapy, at least one of which included a platinum-containing drug.

MEDI4736 is an antibody designed to boost the body’s immune system by targeting a protein on tumor cells called PD-L1. PD-L1 normally maintains the balance of the immune system. In cancer, PD-L1 helps tumors evade detection and elimination by the immune system. MEDI4736 may increase the immune system’s ability to identify 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 IIIB or IV NSCLC that has continued to grow despite at least two prior regimens of therapy, at least one of which included a platinum-containing drug.
  • Patients tumors’ will be tested for PD-L1, and they must contain this protein for the patient to participate in the study.
  • Patients whose tumors contain EGFR or ALK mutations must have experienced continued cancer growth despite receiving anticancer drugs that targeted these mutated proteins.
  • At least 2-3 weeks, depending on prior therapy, must have passed since completion of previous treatment and entry into the study.
  • This study is for 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