SBRT + Pembrolizumab for Lung Cancer
What You Need to Know Before You Apply
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 unresected Stage I or II (Stage IIB N0, M0) non-small cell lung cancer (NSCLC).The primary study hypothesis is SBRT plus pembrolizumab prolongs Event-free Survival (EFS) compared to SBRT plus placebo (normal saline solution).
Who Is on the Research Team?
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Are You a Good Fit for This Trial?
Adults with untreated Stage I or II non-small cell lung cancer (NSCLC) who can't have surgery, are eligible for SBRT, and have good organ function. Participants must agree to contraception if of childbearing potential. Exclusions include active infections, HIV, prior immunotherapy treatments, recent live vaccines, certain autoimmune diseases, pregnancy/breastfeeding, and a history of other cancers within 3 years.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive SBRT once every 3 days for 3, 4, 5, or 8 fractions over approximately 2 weeks, plus pembrolizumab or placebo every 3 weeks for up to 17 cycles (up to approximately 1 year)
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Participants are monitored for overall survival and adverse events
What Are the Treatments Tested in This Trial?
Interventions
- Pembrolizumab
- Placebo
- Stereotactic Body Radiotherapy (SBRT)
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme Corp.
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme Corp.
Chief Medical Officer
Engineering degree from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme Corp.
Chief Executive Officer since 2021
J.D. from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
Merck Sharp & Dohme LLC
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University