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.
Pembrolizumab (Keytruda); Placebo ()
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