A Phase II Study of Immunotherapy with Nivolumab plus Ipilimumab in Patients with Untreated Metastatic Lung Cancer

Full Title

An Open-Label, Single Arm Phase II Study of Nivolumab in Combination with Ipilimumab as First Line-Therapy in Stage IV Non-Small Cell Lung Cancer (NSCLC)


Nivolumab, an immunotherapy drug, is approved to treat several types of cancer, including some forms of non-small cell lung cancer. It is also approved in combination with another immunotherapy drug, ipilimumab, for patients with melanoma. In this study, researchers are examining the safety and effectiveness of giving nivolumab plus ipilimumab in patients with previously untreated metastatic non-small cell lung cancer.

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 mechanism by expressing PD-L1, enabling them to escape attack by the body’s white blood cells. Nivolumab blocks PD-1, enhancing the body’s ability to detect and destroy cancer cells.

Ipilimumab is an antibody against CTLA-4, a molecule that controls a part of the immune system by shutting it down at the right time. The use of nivolumab and ipilimumab together for treating non-small cell lung cancer is considered investigational. Both drugs are given intravenously (by vein).


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

  • Patients must have stage IV non-small cell lung cancer and must not yet have received treatment for metastatic disease.
  • Patients may have had prior chemotherapy or radiation therapy for earlier stage lung cancer if it was completed at least 6 months before entering the study.
  • Patients’ tumors must contain normal EGFR and ALK genes. Lung cancers with mutated forms of these genes can be treated with other drugs.
  • 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. Matthew Hellmann at 646-888-4863.