CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 233 enrolled
Drug / intervention
Pembrolizumab +3 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.

Search/NCT03322566
NCT03322566Phase 2Completed
CompareCT.gov

A Randomized Phase 2 Study of the Combination of Pembrolizumab (MK-3475) Plus Epacadostat (INCB024360) 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

Incyte Corporation·interventional·Posted Oct 26, 2017·Updated Jan 24, 2022

In Brief

A Phase 2 clinical trial evaluating Pembrolizumab, Epacadostat, and 2 other interventions for Lung Cancer. Completed, enrolled 233 participants across 94 sites in 14 countries.

Detailed Summary

The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat with platinum-based chemotherapy versus pembrolizumab plus platinum-based chemotherapy plus placebo as first-line therapy in participants with metastatic non-small cell lung cancer (NSCLC).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer
CountriesAustralia, Canada, Hungary, Ireland, Israel, Italy, Mexico, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedOct 26, 2017
Enrollment StartJan 9, 2018
Primary CompletionDec 13, 2018
Study CompletionOct 16, 2020
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 8.7 years ago

Interventions

Pembrolizumabdrug

Pembrolizumab administered intravenously every 3 weeks.

Epacadostatdrug

Epacadostat administered orally twice daily.

Platinum-based chemotherapydrug

Investigator selected one of the following regimens: pemetrexed + cisplatin, pemetrexed + carboplatin, or paclitaxel + carboplatin, depending on histology.

Placebodrug

Matching placebo administered orally twice daily.