A Phase I Study of Certolizumab plus Chemotherapy for Patients with Stage IV Lung Adenocarcinoma

Protocol
13-063
Full Title
A Phase I Trial of Certolizumab in Combination with Chemotherapy for Patients with Stage IV Lung Adenocarcinomas
Phase
I
Purpose

Cisplatin and pemetrexed are standard chemotherapy drugs used to treat lung cancer. Researchers hope that giving another drug called certolizumab with cisplatin and pemetrexed in patients with stage IV adenocarcinoma of the lung (a type of metastatic lung cancer) may be more effective than standard chemotherapy alone. The purpose of this study is to find the highest dose of certolizumab that can be given safely with cisplatin and pemetrexed in these patients.

Certolizumab is FDA approved for the treatment of certain inflammatory diseases, such as rheumatoid arthritis and inflammatory bowel disease, but its use in patients with lung cancer is considered investigational. It reduces inflammation by blocking a protein called tumor necrosis factor-alpha (TNF-alpha). Research has shown that blocking inflammation may make chemotherapy more effective. Certolizumab may also help prevent cancer from spreading to new organs. It is given as an injection under the skin.

Eligibility

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

  • Patients must have stage IV lung adenocarcinoma that has not yet been treated.
  • Patients may not have previously taken TNF-alpha inhibitors.
  • Patients with rheumatoid arthritis, inflammatory bowel disease, or psoriatic arthritis may not participate.
  • This study is for patients age 18 and older.

For more information about this study or to inquire about eligibility, please contact Dr. Paul K. Paik at 646-888-4202.

Disease(s)
Lung Cancer, Non-Small Cell: Lung Adenocarcinoma