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A Randomized Phase 3 Study of the Combination of Pembrolizumab (MK-3475) Plus Epacadostat (INCB024360) Alone or With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo as First-Line Treatment in Patients With Metastatic Non-Small Cell Lung Cancer
Primary Objectives
To compare OS of the combinations of epacadostat + pembrolizumab AND epacadostat + pembrolizumab + chemotherapy versus placebo + pembrolizumab + chemotherapy.
Hypothesis (H1): The combination of epacadostat + pembrolizumab + chemotherapy has superior OS compared to
placebo + pembrolizumab + chemotherapy.
Hypothesis (H2): The combination of epacadostat + pembrolizumab has superior OS compared to placebo +
pembrolizumab + chemotherapy.
To compare the PFS of the combinations of epacadostat + pembrolizumab AND epacadostat + pembrolizumab +
chemotherapy versus placebo + pembrolizumab + chemotherapy.
Hypothesis (H3): The combination of epacadostat + pembrolizumab + chemotherapy has superior PFS compared to
placebo + pembrolizumab + chemotherapy.
Hypothesis (H4): The combination of epacadostat + pembrolizumab has superior PFS compared to placebo +
pembrolizumab + chemotherapy.
Secondary Objectives
To compare ORR of the combinations of epacadostat + pembrolizumab AND epacadostat + pembrolizumab +
chemotherapy versus placebo + pembrolizumab + chemotherapy.
Hypothesis (H5): The combination of epacadostat + pembrolizumab + chemotherapy has superior ORR compared
to placebo + pembrolizumab + chemotherapy.
Hypothesis (H6): The combination of epacadostat + pembrolizumab has superior ORR compared to placebo +
pembrolizumab + chemotherapy.
To evaluate DOR of the combinations of epacadostat + pembrolizumab, epacadostat + pembrolizumab + chemotherapy,
and placebo + pembrolizumab + chemotherapy.
To evaluate the safety and tolerability of the combinations of epacadostat + pembrolizumab, epacadostat + pembrolizumab + chemotherapy, and placebo + pembrolizumab + chemotherapy.
To evaluate the PK of epacadostat.
Tertiary/Exploratory Objectives
To compare the PFS and ORR per Modified RECIST 1.1 for Immune-based Therapeutics (iRECIST) of the combinations of epacadostat + pembrolizumab AND epacadostat + pembrolizumab + chemotherapy versus placebo + pembrolizumab + chemotherapy.
To compare the proportion of participants with worsened fatigue,nausea/vomiting, appetite loss, constipation, sore mouth, and peripheral neuropathy for epacadostat + pembrolizumab AND epacadostat + pembrolizumab + chemotherapy versus placebo + pembrolizumab + chemotherapy.
To evaluate patient reported outcomes (PROs) as assessed byEORTC Quality of Life Questionnaire-Core 30 items (EORTC QLQ-C30), EORTC questionnaire 13-item lung cancer-specificmodule (EORTC QLQ-LC-13)], and a measure of general health status EQ-5D-5L in patients treated with epacadostat + pembrolizumab, epacadostat + pembrolizumab + chemotherapy, and placebo + pembrolizumab + chemotherapy.
To compare time to true deterioration (TTD) in the composite endpoint of cough, chest pain, and dyspnea between epacadostat + pembrolizumab AND epacadostat + pembrolizumab + chemotherapy versus placebo + pembrolizumab + chemotherapy
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 OS of the combinations of epacadostat + pembrolizumab AND epacadostat + pembrolizumab + chemotherapy versus placebo + pembrolizumab + chemotherapy.
Hypothesis (H1): The combination of epacadostat + pembrolizumab + chemotherapy has superior OS compared to
placebo + pembrolizumab + chemotherapy.
Hypothesis (H2): The combination of epacadostat + pembrolizumab has superior OS compared to placebo +
pembrolizumab + chemotherapy.
To compare the PFS of the combinations of epacadostat + pembrolizumab AND epacadostat + pembrolizumab +
chemotherapy versus placebo + pembrolizumab + chemotherapy.
Hypothesis (H3): The combination of epacadostat + pembrolizumab + chemotherapy has superior PFS compared to
placebo + pembrolizumab + chemotherapy.
Hypothesis (H4): The combination of epacadostat + pembrolizumab has superior PFS compared to placebo +
pembrolizumab + chemotherapy.
Secondary Objectives
To compare ORR of the combinations of epacadostat + pembrolizumab AND epacadostat + pembrolizumab +
chemotherapy versus placebo + pembrolizumab + chemotherapy.
Hypothesis (H5): The combination of epacadostat + pembrolizumab + chemotherapy has superior ORR compared
to placebo + pembrolizumab + chemotherapy.
Hypothesis (H6): The combination of epacadostat + pembrolizumab has superior ORR compared to placebo +
pembrolizumab + chemotherapy.
To evaluate DOR of the combinations of epacadostat + pembrolizumab, epacadostat + pembrolizumab + chemotherapy,
and placebo + pembrolizumab + chemotherapy.
To evaluate the safety and tolerability of the combinations of epacadostat + pembrolizumab, epacadostat + pembrolizumab + chemotherapy, and placebo + pembrolizumab + chemotherapy.
To evaluate the PK of epacadostat.
Tertiary/Exploratory Objectives
To compare the PFS and ORR per Modified RECIST 1.1 for Immune-based Therapeutics (iRECIST) of the combinations of epacadostat + pembrolizumab AND epacadostat + pembrolizumab + chemotherapy versus placebo + pembrolizumab + chemotherapy.
To compare the proportion of participants with worsened fatigue,nausea/vomiting, appetite loss, constipation, sore mouth, and peripheral neuropathy for epacadostat + pembrolizumab AND epacadostat + pembrolizumab + chemotherapy versus placebo + pembrolizumab + chemotherapy.
To evaluate patient reported outcomes (PROs) as assessed byEORTC Quality of Life Questionnaire-Core 30 items (EORTC QLQ-C30), EORTC questionnaire 13-item lung cancer-specificmodule (EORTC QLQ-LC-13)], and a measure of general health status EQ-5D-5L in patients treated with epacadostat + pembrolizumab, epacadostat + pembrolizumab + chemotherapy, and placebo + pembrolizumab + chemotherapy.
To compare time to true deterioration (TTD) in the composite endpoint of cough, chest pain, and dyspnea between epacadostat + pembrolizumab AND epacadostat + pembrolizumab + chemotherapy versus placebo + pembrolizumab + chemotherapy
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.
Recruitment Status
Past Studies