A Phase III Study of BMS-936558 versus Docetaxel in Patients with Previously Treated Metastatic Non-Squamous Non-Small Cell Lung Cancer

Protocol
12-252
Full Title
An Open-Label Randomized Phase III Trial of BMS-936558 Versus Docetaxel in Previously Treated Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Purpose

Docetaxel is a chemotherapy drug commonly used to treat non-squamous non-small cell lung cancer (NSCLC) that has continued to grow despite initial chemotherapy. However, in most patients, the cancer continues to grow. The purpose of this study is to compare the effectiveness of the investigational drug BMS-936558 with docetaxel in patients with non-squamous NSCLC that has persisted despite prior therapy.

BMS-936558 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. BMS-936558 binds to and inactivates PD-1, enhancing the body’s ability to detect and destroy cancer cells.

Patients will be randomly assigned to receive BMS-936558 or docetaxel. Each drug is given intravenously.

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 non-squamous NSCLC that has continued to grow despite one prior regimen of platinum-containing chemotherapy.
  • Patients may not have had prior therapy with docetaxel or an anti-PD-1 drug.
  • 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
Lung Cancer, Non-Small Cell: Other
Locations