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A Phase 2 Trial of Pembrolizumab (MK-3475) in Combination with
Platinum Doublet Chemotherapy and Radiotherapy for Participants with Unresectable,
Locally Advanced Stage III Non-Small Cell Lung Cancer (NSCLC) (KEYNOTE-799)
Primary Objectives
Objective: Within each platinum doublet chemotherapy cohort, evaluate the percentage of participants who develop Grade 3 or higher pneumonitis
Objective: Within each platinum doublet chemotherapy cohort, estimate the ORR as assessed by BICR according to RECIST 1.1
Secondary Objectives
Objective: Within each platinum doublet chemotherapy cohort, evaluate the PFS assessed by BICR
according to RECIST 1.1
Objective: Within each platinum doublet chemotherapy cohort, evaluate OS
Objective: Within each platinum doublet chemotherapy cohort, evaluate the safety and tolerability of
each treatment regimen by the percentage of participants who develop AEs
Tertiary/Exploratory Objectives
Objective: Within each platinum doublet chemotherapy cohort, evaluate OS and distant metastases
per RECIST 1.1 based on BICR
Objective: 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 pembrolizumab in combination with platinum doublet chemotherapy and radiotherapy
Primary Objectives
Objective: Within each platinum doublet chemotherapy cohort, evaluate the percentage of participants who develop Grade 3 or higher pneumonitis
Objective: Within each platinum doublet chemotherapy cohort, estimate the ORR as assessed by BICR according to RECIST 1.1
Secondary Objectives
Objective: Within each platinum doublet chemotherapy cohort, evaluate the PFS assessed by BICR
according to RECIST 1.1
Objective: Within each platinum doublet chemotherapy cohort, evaluate OS
Objective: Within each platinum doublet chemotherapy cohort, evaluate the safety and tolerability of
each treatment regimen by the percentage of participants who develop AEs
Tertiary/Exploratory Objectives
Objective: Within each platinum doublet chemotherapy cohort, evaluate OS and distant metastases
per RECIST 1.1 based on BICR
Objective: 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 pembrolizumab in combination with platinum doublet chemotherapy and radiotherapy
Recruitment Status
Past Studies