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Brief Title: Cisplatin and Etoposide Plus Radiation Followed By Nivolumab/Placebo For Locally Advanced NSCLC
Official Title: Randomized, Double Blinded Phase III Trial of Cisplatin and Etoposide Plus Thoracic Radiation Therapy Followed By Nivolumab/Placebo For Locally Advanced Non-Small Cell Lung Cancer
Study ID: NCT02768558
Brief Summary: Patients with Stage III unresectable non-small cell lung cancer will receive thoracic radiation, cisplatin and etoposide followed by nivolumab or placebo given every 2 weeks for a year.
Detailed Description: PRIMARY OBJECTIVES: I. To compare the Overall Survival (OS) for patients with Stage III unresectable non-small cell lung cancer treated with or without nivolumab following concurrent chemoradiation. II. To compare Progression-Free Survival (PFS) according to RECIST 1.1 criteria for patients with Stage III unresectable non-small cell lung cancer treated with or without nivolumab following concurrent chemoradiation.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
UC San Diego Moores Cancer Center, La Jolla, California, United States
Stanford University, Stanford, California, United States
University of Florida, Gainesville, Florida, United States
Mount Sinai Cancer Research Center, Miami Beach, Florida, United States
Nancy N. & J.C. Lewis Cancer & Research Pavilion at St. Joseph's/Candler Hospital, Savannah, Georgia, United States
University of Kentucky, Lexington, Kentucky, United States
Mercy Medical Cancer Center, Baltimore, Maryland, United States
Henry Ford Health System, Detroit, Michigan, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
University of Rochester, Rochester, New York, United States
Metro Health Medical Center, Cleveland, Ohio, United States
Reading Hospital/McGlinn Cancer Institute, West Reading, Pennsylvania, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
Inova Fairfax Hospital, Falls Church, Virginia, United States
Virginia Mason, Seattle, Washington, United States
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States
Name: David Gerber, MD
Affiliation: RTOG Foundation
Role: PRINCIPAL_INVESTIGATOR