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

Part of paid clinical trials in La Jolla, California.

Sponsor
RTOG Foundation, Inc.
Study ID
NCT02768558
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Radiation Therapy (RT) — RADIATION
    2 Gy fractions once a day, 5 days per week, for a total of 60 Gy in 30 fractions.
  • Cisplatin — DRUG
    Concurrently with radiation therapy, 50 mg/m2, IV, on days 1, 8, 29, and 36, to begin with day 1 of radiation therapy.
  • Etoposide — DRUG
    Concurrently with radiation, 40 mg/m2, IV, on days 1-5 and 29-33, to begin with day 1 of radiation therapy.
  • Nivolumab — DRUG
    Beginning 4-12 weeks after chemoradiation, 240 mg, IV, every 2 weeks for 16 weeks, then 480 mg, IV, for 36 weeks.
  • Placebo — OTHER
    Beginning 4-12 weeks after chemoradiation, 240 mg, IV, every 2 weeks for 16 weeks, then 480 mg, IV, for 36 weeks.

Study Details

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.

Key Dates

Start date
Oct 17, 2016
Status verified
Oct 2020
Primary completion
Jan 23, 2019
Completion
Jan 23, 2019

Study Design

Enrollment
20 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab
    60 Gy of radiation therapy given concurrently with cisplatin-etoposide chemotherapy followed by nivolumab
  • Placebo Comparator: Placebo
    60 Gy of radiation therapy given concurrently with cisplatin-etoposide chemotherapy followed by placebo

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: From registration to study termination. Maximum follow-up was 14.9 months. ]

Locations (16)

FacilityCityStateZIPSite coordinators
UC San Diego Moores Cancer CenterLa JollaCalifornia92093-
Stanford UniversityStanfordCalifornia94305-
University of FloridaGainesvilleFlorida32610-
Mount Sinai Cancer Research CenterMiami BeachFlorida33140-
Nancy N. & J.C. Lewis Cancer & Research Pavilion at St. Joseph's/Candler HospitalSavannahGeorgia31405-
University of KentuckyLexingtonKentucky40536-
Mercy Medical Cancer CenterBaltimoreMaryland21202-
Henry Ford Health SystemDetroitMichigan48202-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
University of RochesterRochesterNew York14642-
Metro Health Medical CenterClevelandOhio44109-
Reading Hospital/McGlinn Cancer InstituteWest ReadingPennsylvania19611-
University of Texas Southwestern Medical CenterDallasTexas75390-
Inova Fairfax HospitalFalls ChurchVirginia22042-
Virginia MasonSeattleWashington98101-
University of Wisconsin Hospital and ClinicsMadisonWisconsin53792-

Find similar trials in La Jolla, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
UC San Diego Moores Cancer Center· La Jolla, CAStanford University· Stanford, CAUniversity of Florida· Gainesville, FLMount Sinai Cancer Research Center· Miami Beach, FLNancy N. & J.C. Lewis Cancer & Research Pavilion at St. Joseph's/Candler Hospital· Savannah, GAUniversity of Kentucky· Lexington, KY

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