S1914: A Randomized Phase III Trial of Induction/Consolidation Atezolizumab (NSC #783608) + SBRT Versus SBRT Alone in High Risk, Early Stage NSCLC

About this Study

The purpose of the study is to how well atezolizumab added to the usual radiation therapy works in treating patients with stage I-IIA non-small cell lung cancer.

Sponsor Protocol ID:S1914
IRB Number:2021-0641
Actively Enrolling
Interventional
Phase 3
July 19, 2022
Eligibility Criteria
18 years old
Both Male and Female
Yes
No
No

Inclusion Criteria
  • Must have histologically or cytologically proven stage I-IIA or limited T2N0M0 non-small cell lung cancer (NSCLC), without radiographic evidence of nodal or distant involvement
  • Must have one or more high risk features:¬† tumor diameter is greater than or equal to 2 cm; SUV max greater than or equal to 6.2 assessed by FDG PET/CT; or moderately differentiated, poorly differentiated, or undifferentiated histology
  • Must have had diagnostic chest CT with contrast with 42 days prior to randomization
  • Must have undergone FDG PET/CT of chest within 90 days prior to randomization
  • Must be medically or surgically inoperable as documented by a board certified thoracic surgeon or multi-disciplinary tumor board consensus OR patient's unwillingness to undergo surgical resection

Exclusion Criteria
  • Evidence of hilar or mediastinal nodal involvement
  • Received any prior treatment for the current NSCLC diagnosis
  • Received prior radiation to overlapping regions of the chest that, in the opinion of treating physician, will interfere with protocol treatment
  • Received treatment with systemic immunostimulatory or immunosuppressive agents, including corticosteroids, within 14 days prior to randomization
  • Significant cardiovascular disease
  • Myocardial infarction within 90 days prior to randomization
  • Unstable arrhythmias or unstable angina
  • Infection that requires IV antibiotic, antifungal, or antiviral treatment
  • Active autoimmune disease that require systemic treatment in the past two years
  • Active (chronic or acute) hepatitis B or hepatitis C infection
  • Know human immunodeficiency virus (HIV) unless he/she is on effective anti-retroviral therapy
  • Prior or current malignancy¬†
  • Pregnant or breastfeeding¬†

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Cancer
Participating Locations
Cancer Center and Research Institute - UMMC
University Hospital - UMMC
Contact Information
Contact Name: Eulisa Goins-Freeman
Phone Number: 601-815-3936
Email: efreeman2@umc.edu
Principal Investigator:Morgan, Dennis P, M.D.
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