A Phase I Study of Nivolumab with Combination Chemotherapy for Patients with Previously Untreated Stage IIIB or IV Non-Small Cell Lung Cancer

Full Title

A Multi-arm Phase I Safety Study of Nivolumab in Combination with Gemcitabine/Cisplatin, Pemetrexed/Cisplatin, Carboplatin/Paclitaxel, Bevacizumab maintenance, Erlotinib, Ipilimumab or as monotherapy in Subjects with Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC)


Patients diagnosed with non-small cell lung cancer (NSCLC) may receive a variety of chemotherapy drugs as treatment for the disease. The purpose of this study is to find the highest dose of nivolumab that can be given safely in patients with newly diagnosed NSCLC when used in combination with the drugs gemcitabine/cisplatin, pemetrexed/cisplatin, or carboplatin/paclitaxel.

Nivolumab 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. It is hoped that by combining it with chemotherapy drugs, cancer cell death can be enhanced. Nivolumab is approved for treating melanoma and some metastatic squamous cell lung cancers; its use for treating other cancers is considered investigational.


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.
  • Patients may not have received prior chemotherapy for NSCLC.
  • Patients may have received radiation therapy, but the last treatment must be 2 or more weeks before entering the study.
  • 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.
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Matthew Hellmann at 646-888-4863.