A Phase II Trial of Concurrent Chemoradiation With Consolidation Pembrolizumab (MK-3475) for the Treatment of Inoperable or Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC): LUN14-179

SUMMARY

You have been asked to participate in this research study because you have Stage III non-small cell lung cancer (NSCLC) and have completed your chemotherapy and radiation treatment. People who complete their treatment are usually observed on a regular basis for progression of their disease. The purpose of this study is to evaluate the good and bad effects of the study drug called Pembrolizumab (MK-3475) when given after completion of your chemotherapy and radiation. Your treatment on this study is expected to continue for one year, as long as your tumor is responding and you are not experiencing severe side effects. After your treatment on this study is over, your medical condition will continue to be followed indefinitely.

 

About 93 people will take part in this study.

Lung cancer is currently the leading cause of cancer-related mortality in the United States and in the world. It accounts for more deaths that breast, prostate, and colorectal cancer combined. Non-small cell lung cancer (NSCLC) accounts for approximately 85% (85 out of 100) of all primary lung malignancies and outcomes for this disease are poor. Current therapies for advanced NSCLC provide only modest benefits, and new approaches are needed to improve future outcomes in this disease.

 

Pembrolizumab (MK-3475)is a PD-1 inhibiting drug and has been approved by the Food and Drug Administration (FDA) to treat melanoma. Typically, the human body’s immune system recognizes abnormal cells in the body and destroys them. Cancer cells frequently create proteins on the cell surface (PD-L1) that act as signals to turn off this part of the immune system. Pembrolizumab (MK-3475)is a drug that blocks (inhibits) this signal on the immune system’s cells (PD-1) and allows the immune system to recognize these cancer cells as foreign.

 

The use of Pembrolizumab (MK-3475)in this study is investigational. “Investigational” means that this medication has not yet been approved by the FDA to treat the type of cancer you have. This research study is to find out whether the PD-1 inhibiting drug, Pembrolizumab (MK-3475), is effective at lengthening the time until non-small cell lung cancer starts to grow.

COH Protocol Number : 15038

ClinicalTrials.gov Number : NCT02343952

Principal Investigator : Reckamp, Karen M.D.

Sponsor : Indiana University Health Simon Cancer Center

BRIEF ELIGIBILITY CRITERIA :

Eligible Ages : N/A

Gender : Either

Minimum Performance Status : ECOG/SWOG:1

Treatment Intent : Non-Adjuvant treatment

Prior Chemotherapy :

Brain Metastases :

Measurable Disease :