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)

Completed · Phase 2 · Has a placebo group

Conditions studied: Lung Cancer

In brief

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).

Key facts

Study ID

NCT03322566

Run by

Incyte Corporation

People needed

233

Starts

2018-01-09

Expected to finish

2020-10-16

Last updated by the study team

2022-01-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• New York Oncology Hematology P.C — Albany, New York, United States
• Oncology Hematology Care, Inc. — Cincinnati, Ohio, United States
• Southwestern Regional Medical Center, Inc. — Tulsa, Oklahoma, United States
• St. Luke's Hospital - Anderson Campus — Easton, Pennsylvania, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• Tennessee Oncology, PLLC/The Sarah Cannon Research Institute — Chattanooga, Tennessee, United States
• Tennessee Oncology, PLLC/The Sarah Cannon Research Institute — Nashville, Tennessee, United States
• Texas Oncology-Denton South — Denton, Texas, United States
• Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care — Blacksburg, Virginia, United States
• Emily Couric Clinical Cancer Center — Charlottesville, Virginia, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States
• Blacktown Hospital — Blacktown, New South Wales, Australia
• Chris OBrien Lifehouse — Camperdown, New South Wales, Australia
• The Crown Princess Mary Cancer Centre Westmead — Westmead, New South Wales, Australia
• Southern Medical Day Care Centre — Wollongong, New South Wales, Australia
• Southern Cancer Center, PC — Daphne, Alabama, United States

Full record on ClinicalTrials.gov

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