A Phase III Study Comparing Standard Chemotherapy, Nivolumab Alone, or Nivolumab plus Ipilimumab Immunotherapy in Patients with Metastatic Non-Small Cell Lung Cancer

Full Title

An Open-Label, Randomized Phase 3 Trial of Nivolumab, or Nivolumab plus Ipilimumab, or Nivolumab plus Platinum Doublet Chemotherapy versus platinum doublet chemotherapy in Subjects with Chemotherapy-Naïve Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)

Purpose

Standard chemotherapy drugs for metastatic non-small cell lung cancer (NSCLC) include carboplatin or cisplatin with pemetrexed or gemcitabine. Nivolumab is a newer drug approved for treating several types of cancer, including some non-small cell lung cancers. In this study, researchers want to compare three different regimens of therapy in patients who have not yet received treatment for metastatic NSCLC:

  • Standard chemotherapy
  • Nivolumab alone
  • Nivolumab plus ipilimumab

Nivolumab and ipilimumab are immunotherapy drugs. They work by boosting the power of the immune system to fight cancer cells. Ipilimumab is approved for treating melanoma, but its use in this study is considered investigational.

Patients will be randomly assigned to one of the three treatment groups, and researchers will compare the effectiveness of the different therapies. All of these medications 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 metastatic NSCLC and may not have received treatment yet for advanced disease.
  • No prior chemotherapy is allowed unless it was given before or after surgery as adjuvant therapy; chemoradiation is permitted for localized disease. At least 6 months must have passed between completion of treatment and entry into the study.
  • Patients with EGFR and ALK mutations may not participate because they can receive other treatments that target these mutations.
  • Participants must have tumor tissue available for testing for PD-L1 status (the target of nivolumab).
  • 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.

Protocol

15-251

Phase

III

Investigator

Co-Investigators

Locations