Testing the effects of MK-3475 (pembrolizumab) with or without the usual chemotherapy treatment for patients 70 years old and older with advanced non-small cell lung cancer

Researchers are studying if there are any side effects of the FDA-approved immunotherapy Keytruda® (pembrolizumab) with or without chemotherapy in treating patients with stage 4 non-small cell lung cancer that has recurred and spread to other places in the body.

Immunotherapies may help the body’s immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Researchers seek to determine if administering pembrolizumab with or without chemotherapy may shrink tumors in older patients.

Eligible participants are grouped into two study arms:

• Group A receives pembrolizumab intravenously over 30 minutes on day 1. Cycles repeat every 21 or 42 days.
• Group B receives pembrolizumab and the chemotherapies pemetrexed and carboplatin intravenously over 30 minutes on day 1. Cycles for pembrolizumab repeat every 21 or 42 days. Cycles for the chemotherapies repeat every 21 days.

The primary outcome being studied is to estimate the adverse event profile of pembrolizumab in advanced non-small cell lung cancer patients age 70 years or older and who are treated with or without chemotherapy in a first-line setting.