A Phase III Study of Nivolumab versus Standard Chemotherapy as Initial Treatment for Metastatic or Recurrent Non-Small Cell Lung Cancers that Express PD-L1

Protocol
14-095
Full Title
An Open-Label, Randomized, Phase 3 Trial of Nivolumab versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer
Phase
III
Purpose

Nivolumab boosts the body’s immune system by targeting a protein on cells called PD-L1. PD-L1 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-L1, enabling them to escape attack by the immune system. Nivolumab binds to and inactivates PD-L1, enhancing the body’s ability to detect and destroy cancer cells.

In this study, researchers are comparing the effectiveness of treatment with nivolumab versus standard first-line chemotherapy in patients with metastatic or recurrent non-small cell lung cancer (NSCLC) that express PD-L1. Examples of the standard chemotherapy drugs used in this study include carboplatin or cisplatin with gemcitabine, paclitaxel, or pemetrexed.

Patients will be randomly assigned to receive nivolumab or standard chemotherapy. The chemotherapy regimen will be selected by the treating doctor based on the patient’s type of NSCLC. Those receiving standard chemotherapy whose NSCLC continues to grow will be given the opportunity to receive nivolumab instead.

Nivolumab is approved for treating melanoma; its use for treating other cancers is considered investigational.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have metastatic or recurrent NSCLC that expresses PD-L1.
  • Patients who are candidates for treatments that target EGFR or ALK may not be eligible to participate in this study.
  • Patients may not have previously received chemotherapy for advanced lung cancer.
  • 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 for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Jamie Chaft at 646-888-4545.

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