Trial Details 104 Total Sites

Efficacy and Safety Study of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Adults With Unresected Stage I or II Non-Small Cell Lung Cancer (NSCLC) (MK-3475-867/KEYNOTE-867)

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 unresected stage I or II (Stage IIB N0, M0) 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.

phase

Phase 3

status

Recruiting

enrollment

530

score

49

start date

2019-06-25

last updated

2021-12-20

biomarkers

N/A

Philadelphia, Pennsylvania
facility
Fox Chase Cancer Center ( Site 0051)
1 facility
Recruiting
Indianapolis, Indiana
facility
Franciscan Health Indianapolis ( Site 0024)
1 facility
Recruiting
Denver, Colorado
facility
National Jewish Health ( Site 0010)
1 facility
Recruiting
Boston, Massachusetts
facility
Massachusetts General Hospital-Cancer Center Protocol Office ( Site 3007)
1 facility
Recruiting
Baltimore, Maryland
facility
Sinai Hospital of Baltimore ( Site 3011)
1 facility
Recruiting
Nashville, Tennessee
facility
Vanderbilt University Medical Center ( Site 0075)
1 facility
Recruiting
Tampa, Florida
facility
H. Lee Moffitt Cancer Center and Research Institute ( Site 0016)
1 facility
Recruiting
Pittsburgh, Pennsylvania
facility
Allegheny General Hospital ( Site 3028)
1 facility
Recruiting
Gilbert, Arizona
facility
Banner MD Anderson Cancer Center ( Site 3029)
1 facility
Recruiting
Lexington, Kentucky
facility
University of Kentucky School of Medicine & Hospitals ( Site 0026)
1 facility
Recruiting
Birmingham, Alabama
facility
University of Alabama ( Site 0099)
1 facility
Recruiting
Worcester, Massachusetts
facility
University of Massachusetts ( Site 0029)
1 facility
Recruiting