Skip to main content

Summary

for people ages 18 years and up (full criteria)
at Stanford, California and other locations
study started
estimated completion:

Description

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.

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

Details

PRIMARY OBJECTIVES:

  1. 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.

Keywords

Non-Small Cell Lung Cancer Lung Cancer NSCLC Nivolumab Lung Neoplasms Carcinoma, Non-Small-Cell Lung Etoposide phosphate Cisplatin Etoposide Antibodies, Monoclonal

Eligibility

You can join if…

Open to people ages 18 years and up

  • Pathologically (histologically or cytologically) proven diagnosis of NSCLC with unresectable, medically inoperable disease, or patients who refuse resection stage IIIA or stage IIIB disease (AJCC 7th edition)
  • History/physical examination within 30 days prior to registration
  • CT scan with IV contrast (CT scan without contrast acceptable if IV contrast is medically contraindicated) of the lung and upper abdomen through the adrenal glands within 60 days prior to registration (recommended within 30 days prior to registration)
  • MRI of the brain with contrast (or CT with contrast if MRI is medically contraindicated) within 60 days prior to registration; note: the use of intravenous contrast is required for the MRI or CT (unless medically contra-indicated).
  • Whole-body FDG-PET/CT within 60 days prior to registration; Note: patients do not need to have a separate CT of chest and upper abdomen with contrast if PET/CT imaging includes a high quality CT chest with contrast.
  • Age ≥ 18 years
  • The trial is open to both genders
  • Zubrod Performance status of 0-1
  • Forced Expiratory Volume at one second (FEV1) > 1.2 liters; Diffusion Capacity of Lung for Carbon Monoxide (DLCO) ≥ 50% predicted
  • Patients must be at least 3 weeks from prior thoracotomy (if performed); if prior thoracotomy then measurable disease on imaging must be present
  • Negative serum pregnancy test within three days prior to registration for women of childbearing potential
  • An archived tumor block or punches instead block must be available for submission for PD-L1 analysis. If an archived tumor block sample cannot be shipped for this study,then two 3mm punches from the core needle biopsy blocks may be provided for analysis.

NOTE: core or excisional biopsy is required for this study. Fine needle aspirates(FNA) and cytology specimens are not adequate for PD-L1 analysis.

  • Agreement of women of childbearing potential to use highly effective contraception during receipt of study drug and up to 161 days (23 weeks) from the last dose of nivolumab/placebo and men receiving nivolumab/placebo who are sexually active with women of childbearing potential to use highly effective contraception during receipt of study drug for 31 weeks from the last dose of nivolumab/placebo.

You CAN'T join if...

  • Definitive clinical or radiological evidence of metastatic disease
  • Prior or current invasive malignancy (except non-melanomatous skin cancer, localized bladder and prostate cancer) unless disease free for a minimum of 2 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields. For example, patients with prior breast radiotherapy treatments would likely be excluded.
  • Prior systemic treatment with and anti-PD1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways
  • Known immunosuppressive disease, for example HIV infection or history of bone marrow transplant or chronic lymphocytic leukemia (CLL)
  • Chronic Obstructive Pulmonary Disease (COPD) exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration.COPD requiring chronic oral steroid therapy
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
  • Transmural myocardial infarction within the last 6 months
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
  • History of symptomatic or p previously established interstitial lung disease
  • Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection;
  • History of severe hypersensitivity reaction to any monoclonal antibody or allergy to study drug components
  • As there is potential for hepatic toxicity with nivolumab, drugs with a predisposition to hepatotoxicity should be used with caution in patients treated with nivolumab-containing regimen
  • Pregnancy, nursing females or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.

Locations

  • Stanford University
    Stanford, California, 94305, United States
  • UC San Diego Moores Cancer Center
    La Jolla, California, 92093, United States
  • Virginia Mason
    Seattle, Washington, 98101, United States
  • University of Texas Southwestern Medical Center
    Dallas, Texas, 75390, United States
  • University of Wisconsin Hospital and Clinics
    Madison, Wisconsin, 53792, United States
  • University of Kentucky
    Lexington, Kentucky, 40536, United States
  • Henry Ford Health System
    Detroit, Michigan, 48202, United States
  • Metro Health Medical Center
    Cleveland, Ohio, 44109, United States
  • University of Florida
    Gainesville, Florida, 32610, United States
  • Nancy N. & J.C. Lewis Cancer & Research Pavilion at St. Joseph's/Candler Hospital
    Savannah, Georgia, 31405, United States
  • University of Rochester
    Rochester, New York, 14642, United States
  • Inova Fairfax Hospital
    Falls Church, Virginia, 22042, United States
  • Mercy Medical Cancer Center
    Baltimore, Maryland, 21202, United States
  • Reading Hospital/McGlinn Cancer Institute
    West Reading, Pennsylvania, 19611, United States
  • Mount Sinai Cancer Research Center
    Miami Beach, Florida, 33140, United States
  • Memorial Sloan Kettering Cancer Center
    New York, New York, 10065, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
RTOG Foundation, Inc.
ID
NCT02768558
Phase
Phase 3
Lead Scientist
Sue Yom
Study Type
Interventional
Last Updated
November 20, 2017