At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 154 enrolled
Drug / intervention
Pembrolizumab +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, 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
In Brief
A Phase 2 clinical trial evaluating Pembrolizumab, Epacadostat, and 1 other intervention for Lung Cancer. Completed, enrolled 154 participants across 101 sites in 18 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus epacadostat compared to pembrolizumab plus placebo as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC) expressing high levels of programmed cell death ligand 1 (PD-L1).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer
CountriesAustralia, Canada, Denmark, Estonia, Ireland, Israel, Italy, Japan, Malaysia, Poland, Russia, South Korea, Spain, Switzerland, Turkey (Türkiye), Ukraine, United Kingdom, United States
CollaboratorsMerck Sharp & Dohme LLC
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedOct 2017
Enrollment StartDec 2017
Primary CompletionJan 2019
Study CompletionNov 2020
TodayJul 2026
First PostedOct 26, 2017
Enrollment StartDec 15, 2017
Primary CompletionJan 10, 2019
Study CompletionNov 9, 2020
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 8.7 years ago
Interventions
Pembrolizumabdrug
Pembrolizumab administered intravenously every 3 weeks.
Epacadostatdrug
Epacadostat administered orally twice daily.
Placebodrug
Matching placebo administered orally twice daily.