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).
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 2 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jan 24, 2022 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
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
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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.
- 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.