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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) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT03322566•Incyte Corporation

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically or cytologically confirmed diagnosis of stage IV NSCLC without epidermal growth factor receptor (EGFR)-sensitizing mutation, ROS1 and/or anaplastic lymphoma kinase (ALK) translocation
•Measurable disease based on RECIST 1.1
•Life expectancy of at least 3 months.
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
•Adequate organ function per protocol-defined criteria.
•Provide tumor tissue sample.

Exclusion Criteria

•Known untreated central nervous system metastases and/or carcinomatous meningitis
•History of (non-infectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease.
•Symptomatic ascites or pleural effusion.
•Known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
•Active autoimmune disease that has required systemic treatment in past 2 years.
•Has had an allogeneic tissue/solid organ transplant.
•Has a known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by the local health authority.
•Has known history of or is positive for active Hepatitis B (HBsAg reactive) or has active Hepatitis C (HCV RNA). Note: Testing must be performed to determine eligibility.
•History or presence of an abnormal electrocardiogram (ECG) that, in the Investigator's opinion, is clinically meaningful.
•Use of protocol-defined prior/concomitant therapy.

Locations (94)

Southern Cancer Center, PC

Daphne, Alabama, United States

Western Regional Medical Center, Inc.

Goodyear, Arizona, United States

Arizona Oncology Associates PC- HOPE

Tucson, Arizona, United States

Lynn Cancer Institute

Boca Raton, Florida, United States

Florida Cancer Specialists (South Region)

Fort Myers, Florida, United States

Florida Cancer Specialists (North Region)

St. Petersburg, Florida, United States

PPG-Oncology

Fort Wayne, Indiana, United States

University of Michigan

Ann Arbor, Michigan, United States

MMCORC

Saint Louis Park, Minnesota, United States

St. Vincent Healthcare Frontier Cancer Center

Billings, Montana, United States

Key Dates

Start Date

January 9, 2018

Primary Completion Date

December 13, 2018

Completion Date

October 16, 2020

Last Updated

January 24, 2022

Enrollment

233

ACTUAL participants

Conditions

Lung Cancer

Interventions

Pembrolizumab

DRUG

Epacadostat

DRUG

Platinum-based chemotherapy

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 24, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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)

Inclusion Criteria

Exclusion Criteria

Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

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Testing the Addition of an Anti-Cancer Drug, TRC102, to the Usual Chemotherapy Treatment (Pemetrexed, Cisplatin or Carboplatin) During Radiation Therapy for Stage III Non-Squamous Non-Small Cell Lung Cancer

Magnetic Resonance Imaging of the Lung: Oncological Applications