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)
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).
Checked against the public recordLast updated Jan 24, 2022 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Incyte Corporation
- Interventions being studied
- Drug: Pembrolizumab; Drug: Epacadostat; Drug: Platinum-based chemotherapy; Drug: Placebo
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Southern Cancer Center, PCDaphne, Alabama
- Western Regional Medical Center, Inc.Goodyear, Arizona
- Arizona Oncology Associates PC- HOPETucson, Arizona
- Lynn Cancer InstituteBoca Raton, Florida
- Florida Cancer Specialists (South Region)Fort Myers, Florida
- Florida Cancer Specialists (North Region)St. Petersburg, Florida
- PPG-OncologyFort Wayne, Indiana
- University of MichiganAnn Arbor, Michigan
- MMCORCSaint Louis Park, Minnesota
- St. Vincent Healthcare Frontier Cancer CenterBillings, Montana
- New York Oncology Hematology P.CAlbany, New York
- Oncology Hematology Care, Inc.Cincinnati, Ohio
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 24, 2022. Always confirm current availability with the study team.