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)

Phase 2 Completed 233 enrolled Incyte Corporation Merck Sharp & Dohme LLC · collab

RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start: 2018-01-09
Primary completion: 2018-12-13
Completion: 2020-10-16

Publications

Boyer M, Hui R, Urban D, Clingan P, Su WC, Devaux C, Gadgeel S, Garassino M, Leopold L, Daniel J, Munteanu MC, Samkari A, Luo Y, Abreu DR. Pembrolizumab with platinum-based chemotherapy with or without epacadostat as first-line treatment for metastatic non-small cell lung cancer: a randomized, partially double-blind, placebo-controlled phase II study. BMC Cancer. 2024 Jul 25;23(Suppl 1):1250. doi: 10.1186/s12885-022-10427-4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Epacadostat	Small molecule	100 mg	Oral
Background	Carboplatin	Small molecule	5 unknown	Intravenous
Background	Carboplatin	Small molecule	6 unknown	Intravenous
Background	Cisplatin	Other / unclassified	75 mg/m2	Intravenous
Background	Paclitaxel	Small molecule	200 mg/m2	Intravenous
Background	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous
Background	Pemetrexed	Small molecule	500 mg/m2	Intravenous

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)

Summary

Timeline

Publications

Drugs

Indications