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

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

Outcome

Missed primary endpoint

registry analysis (superiority test); Pembrolizumab + Chemotherapy + Epacadostat vs Pembrolizumab + Chemotherapy + Placebo; p = 0.9948; Difference in Percentages -18.5 (95% CI -32.0 to -4.3) NCT03322566 ↗

paper did not improve ORR in patients with treatment-naïve metastatic NSCLC. PMID 39054462 ↗

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

Indications