A Phase 3, Randomized, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Participants With Medically Inoperable Stages I or IIA Non Small Cell Lung Cancer (NSCLC) (KEYNOTE-867)
Conditions
Lung
Phase III
Volunteers
Health Professionals
What is the purpose of this trial?
The purpose of this study is to assess the efficacy and safety of stereotactic body radiotherapy (SBRT) plus pembrolizumab (MK-3475) in the treatment of adult participants with medically inoperable Stage I or IIA non-small cell lung cancer (NSCLC).
The primary study hypotheses are:
- SBRT plus pembrolizumab prolongs Event-free Survival (EFS) compared to SBRT plus placebo (normal saline solution), and
- SBRT plus pembrolizumab prolongs Overall Survival (OS) compared to SBRT plus placebo.
- Trial withMerck Sharp & Dohme
- Start Date08/01/2019
- End Date04/10/2025
I'm interested in volunteering
If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email helpusdiscover@yale.edu or call 877.978.8343
Principal Investigator
Sub-Investigators
- Anne Chiang, MD, PhD
- Christin A. Knowlton, MD, MA
- Emily Duffield, APRN
- Frederick Wilson, MD, PhD
- Henry S. Park, MD, MPH
- James B. Yu, MD, MHS
- Joseph N. Contessa, MD, PhD
- Kathryn Medow, APRN
- Kimberly L. Johung, MD, PhD
- Marianne Davies, NP
- Meena S. Moran, MD
- Ranjit S. Bindra, MD, PhD
- Roy S. Herbst, MD, PhD
- Sarah Goldberg, MD, MPH
- Scott Gettinger, MD
- Susan A. Higgins, MD
- Suzanne B. Evans, MD, MPH
- Last Updated12/05/2019
- Study HIC#2000025217