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)
This study will evaluate safety and effectiveness of radiotherapy with or without Pembrolizumab in participants who are at least 18 years of age with medically inoperable Stage I or IIA NSCLC who have received no prior anticancer therapy for the present lung cancer.
The screening phase will be up to 42 days; if eligible, each participant will receive study treatment until the occurrence of the following events: documented disease recurrence, unacceptable adverse events, other illness that prevents further administration of treatment, death from any cause, investigator decision, participant decision, or withdrawal of consent, or until the participant has received 17 administrations of pembrolizumab or placebo (approximately 1 year).
All participants will be followed by telephone for overall survival until death, withdrawal of consent, or the end of the study.
Ryan Nowak, MD;Steven Powell, MD,Miran Blanchard, MD,Elie Chalhoub, MD