Cancer Type: Thoracic
Study Type: Treatment
NCT#: NCT03924869
Phase: Phase III
Principal Investigator: Gray, Jhanelle
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)
he 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).
Primary Objectives: To compare the Event Free Survival (EFS). To compare Overall Survival(OS). Secondary Objectives: To compare the time to death or distant metastases. To evaluate the safety and tolerability of SBRT + embrolizumab. To compare the change from baseline scores in global health status/ quality of life (QoL), cough, chest pain, dyspnea, and physical functioning scale. Tertiary/Exploratory Objectives: To compare the time to subsequent treatment (TTST). To compare the disease-specific survival (DSS). To characterize health utility using the 5 level version of the European Quality of Life (EuroQoL) 5 dimension Questionnaire (EQ-5D-5L) to generate utility scores for use in economic models. To identify molecular (genomic, metabolic, and/or proteomic) biomarkers that may be indicative of clinical response/resistance, safety, pharmacodynamic activity, and/or the mechanism of action of SBRT + pembrolizumab.
Immunotherapy; Radiotherapy
Pembrolizumab (Keytruda); Placebo ()
If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.
Back to top
Please call 1-888-663-3488 for support from a Moffitt representative. New Patients and Healthcare Professionals can submit an online form by selecting the appropriate button below. Existing patients can call 1-888-663-3488. Click here for a current list of insurances accepted at Moffitt.
NEW PATIENTS To request a new patient appointment, please fill out the online form or call 1-888-663-3488.
REFERRING PHYSICIANS Providers and medical staff can refer patients by submitting our online referral form.
Moffit now offers Virtual Visits for patients. If you are eligible for a virtual appointment, our scheduling team will discuss this option further with you.
Moffitt Cancer Center is committed to the health and safety of our patients and their families. For more information on how we’re protecting our new and existing patients, visit our COVID-19 Info Hub
Our patient services specialists can assist you with scheduling an appointment, questions about medical records, insurance, billing and more.
Patient Appointment Center Hours: 7 a.m. to 7 p.m. Monday - Friday; 8 a.m. to noon Saturday