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A Phase 3, Randomized, Double-Blind Study of Pembrolizumab (MK-3475) Plus Epacadostat (INCB024360) Versus Pembrolizumab Plus Placebo as First-Line Treatment in Patients With Metastatic Non-Small Cell Lung Cancer Expressing High Levels of PD-L1

Primary Objectives To compare PFS of the combination of pembrolizumab plus epacadostat versus pembrolizumab plus placebo. Hypothesis (H1): The combination of pembrolizumab plus epacadostat has superior PFS compared to pembrolizumab plus placebo. To compare OS of the combination of pembrolizumab plus epacadostat versus pembrolizumab plus placebo. Hypothesis (H2): The combination of pembrolizumab plus epacadostat has superior OS compared to pembrolizumab plus placebo. Secondary Objectives To compare ORR of the combination of pembrolizumab plus epacadostat versus pembrolizumab plus placebo. Hypothesis (H3): The combination of pembrolizumab plus epacadostat has superior ORR compared to pembrolizumab plus placebo. To evaluate DOR of the combinations of pembrolizumab plus epacadostat and pembrolizumab plus placebo. To evaluate the safety and tolerability of the combinations of pembrolizumab plus epacadostat and pembrolizumab plus placebo. To evaluate the PK of epacadostat. Tertiary Objectives To compare PFS and ORR per Modified RECIST 1.1 for Immune-based Therapeutics (iRECIST) of the combination of pembrolizumab plus epacadostat versus pembrolizumab plus placebo. To compare patient reported outcomes (PROs) between the two treatment arms using the EORTC QLQ-C30/QLQ-LC13 and EQ-VAS. To compare time to true deterioration (TTD) in the composite endpoint of cough, chest pain, and dyspnea between the two treatment arms. To evaluate clinically meaningful thresholds for change in cough, pain in chest, and shortness of breath from the EORTC QLQ-LC13/QLQ-QC30 questionnaires using the Patient Global Impression of Change-Lung Symptoms questionnaire (PGIC-L). To characterize utilities using the EQ-5D-5L. To evaluate the relationship between baseline biomarkers and clinical activity of the treatment groups. To identify molecular (genomic,metabolic, and/or proteomic) biomarkers (eg, kynurenine and tryptophan from serum) that may be indicative of clinical response/resistance, safety, pharmacodynamic activity, and/or the mechanism of action of epacadostat and pembrolizumab.

Primary Objectives To compare PFS of the combination of pembrolizumab plus epacadostat versus pembrolizumab plus placebo. Hypothesis (H1): The combination of pembrolizumab plus epacadostat has superior PFS compared to pembrolizumab plus placebo. To compare OS of the combination of pembrolizumab plus epacadostat versus pembrolizumab plus placebo. Hypothesis (H2): The combination of pembrolizumab plus epacadostat has superior OS compared to pembrolizumab plus placebo. Secondary Objectives To compare ORR of the combination of pembrolizumab plus epacadostat versus pembrolizumab plus placebo. Hypothesis (H3): The combination of pembrolizumab plus epacadostat has superior ORR compared to pembrolizumab plus placebo. To evaluate DOR of the combinations of pembrolizumab plus epacadostat and pembrolizumab plus placebo. To evaluate the safety and tolerability of the combinations of pembrolizumab plus epacadostat and pembrolizumab plus placebo. To evaluate the PK of epacadostat. Tertiary Objectives To compare PFS and ORR per Modified RECIST 1.1 for Immune-based Therapeutics (iRECIST) of the combination of pembrolizumab plus epacadostat versus pembrolizumab plus placebo. To compare patient reported outcomes (PROs) between the two treatment arms using the EORTC QLQ-C30/QLQ-LC13 and EQ-VAS. To compare time to true deterioration (TTD) in the composite endpoint of cough, chest pain, and dyspnea between the two treatment arms. To evaluate clinically meaningful thresholds for change in cough, pain in chest, and shortness of breath from the EORTC QLQ-LC13/QLQ-QC30 questionnaires using the Patient Global Impression of Change-Lung Symptoms questionnaire (PGIC-L). To characterize utilities using the EQ-5D-5L. To evaluate the relationship between baseline biomarkers and clinical activity of the treatment groups. To identify molecular (genomic,metabolic, and/or proteomic) biomarkers (eg, kynurenine and tryptophan from serum) that may be indicative of clinical response/resistance, safety, pharmacodynamic activity, and/or the mechanism of action of epacadostat and pembrolizumab.