A Phase III Study of Nivolumab (BMS-936558) versus Docetaxel in Previously Treated Advanced Squamous Cell Lung Cancer

Protocol
12-203
Full Title
An Open-label Randomized Phase III Trial of BMS-936558 versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC)
Phase
III
Purpose

Nivolumab (BMS-936558) is an investigational anticancer drug that 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. Nivolumab binds to and inactivates PD-1, enhancing the body’s ability to detect and destroy cancer cells.

In this study, researchers are comparing the effectiveness of nivolumab to that of docetaxel, a standard chemotherapy drug, in patients with advanced squamous cell lung cancer that persists despite prior therapy. Patients will be randomly assigned to receive nivolumab or docetaxel, but not both. Both drugs are 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 stage IV squamous cell non-cell lung cancer that has persisted or returned despite one prior regimen of platinum-containing doublet chemotherapy.
  • Patients may not have previously received docetaxel, nor therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
  • Patients must have recovered from the serious side effects of prior therapies.
  • 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 ages 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