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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)

NCT03322566 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 233

Last updated 2022-01-24

Study results available
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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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Lance Leopold, MD · Incyte Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-09
Primary Completion
2018-12-13
Completion
2020-10-16
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Hungary
  • Ireland
  • Israel
  • Italy
  • Mexico
  • Russia
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03322566 on ClinicalTrials.gov