NCT03322566

A Study of Pembrolizumab Plus Epacadostat With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-715-06/ECHO-306-06)

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 233 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Pembrolizumab administered intravenously every 3 weeks.
DRUG	Epacadostat	Epacadostat administered orally twice daily.
DRUG	Platinum-based chemotherapy	Investigator selected one of the following regimens: pemetrexed + cisplatin, pemetrexed + carboplatin, or paclitaxel + carboplatin, depending on histology.
DRUG	Placebo	Matching placebo administered orally twice daily.

Timeline

• Start date: 2018-01-09
• Primary completion: 2018-12-13
• Completion: 2020-10-16
• First posted: 2017-10-26
• Last updated: 2022-01-24
• Results posted: 2020-01-29

Locations

94 sites across 14 countries: United States, Australia, Canada, Hungary, Ireland, Israel, Italy, Mexico, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study