Cisplatin and Etoposide Plus Radiation Followed By Nivolumab/Placebo For Locally Advanced NSCLC

PHASE3TerminatedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

October 17, 2016

Primary Completion Date

January 23, 2019

Study Completion Date

January 23, 2019

Conditions
Non-Small Cell Lung Cancer
Interventions
RADIATION

Radiation Therapy (RT)

2 Gy fractions once a day, 5 days per week, for a total of 60 Gy in 30 fractions.

DRUG

Cisplatin

Concurrently with radiation therapy, 50 mg/m2, IV, on days 1, 8, 29, and 36, to begin with day 1 of radiation therapy.

DRUG

Etoposide

Concurrently with radiation, 40 mg/m2, IV, on days 1-5 and 29-33, to begin with day 1 of radiation therapy.

DRUG

Nivolumab

Beginning 4-12 weeks after chemoradiation, 240 mg, IV, every 2 weeks for 16 weeks, then 480 mg, IV, for 36 weeks.

OTHER

Placebo

Beginning 4-12 weeks after chemoradiation, 240 mg, IV, every 2 weeks for 16 weeks, then 480 mg, IV, for 36 weeks.

Trial Locations (16)

10065

Memorial Sloan Kettering Cancer Center, New York

14642

University of Rochester, Rochester

19611

Reading Hospital/McGlinn Cancer Institute, West Reading

21202

Mercy Medical Cancer Center, Baltimore

22042

Inova Fairfax Hospital, Falls Church

31405

Nancy N. & J.C. Lewis Cancer & Research Pavilion at St. Joseph's/Candler Hospital, Savannah

32610

University of Florida, Gainesville

33140

Mount Sinai Cancer Research Center, Miami Beach

40536

University of Kentucky, Lexington

44109

Metro Health Medical Center, Cleveland

48202

Henry Ford Health System, Detroit

53792

University of Wisconsin Hospital and Clinics, Madison

75390

University of Texas Southwestern Medical Center, Dallas

92093

UC San Diego Moores Cancer Center, La Jolla

94305

Stanford University, Stanford

98101

Virginia Mason, Seattle

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

RTOG Foundation, Inc.

OTHER