A Randomized Phase III Trial of Induction/Consolidation Atezolizumab + SBRT Versus SBRT Alone in High Risk, Early Stage Non-Small Cell Lung Cancer

Protocol: SWOG – S1914

SCHEMA S1914

Please Note:  Below is partial eligibility, for full eligibility requirement’s, please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 and/or (810) 762-8038. Thank you!

Eligibility:

1. Patient must have histologically or cytologically proven Stage I-IIA or limited T3N0M0 non-small cell lung cancer (NSCLC) without radiographic evidence of nodal or distant involvement (N0M0). Patient may have
   T3 disease with the exclusion of multifocal tumors and pericardial involvement.
2. Disease must have one or more of the following high-risk features:
   • Tumor diameter ≥ 2 cm as assessed by diagnostic CT
   • Tumor SUV max ≥ 6.2 as assessed by FDG PET/CT
   • Moderately differentiated, poorly differentiated, or undifferentiated histology.
3. Patient must not have evidence of hilar or mediastinal nodal involvement. Any patient with radiographically suspicious hilar or mediastinal nodes (including features such as non-calcified nodes with a short axis diameter > 1 cm, abnormal
   morphology, and/or elevated FDG avidity) must undergo cytologic sampling of suspicious nodes to rule out involvement prior to randomization. Mediastinal nodal sampling for other patients is optional.
4. Patient 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 must be clearly documented.
5. Patient must not have received any prior treatment for the current NSCLC diagnosis.
6. Patient must not have undergone prior radiation to overlapping regions of the chest that, in the opinion of the treatment physician, will interfere with protocol treatment.
7. Patient must not have received treatment with systemic immunostimulatory or immunosuppressive agents, including corticosteroids, within 14 days prior to randomization.
8. Must be at least 18 years of age.
9. Zubrod Performance Status 0-2.
10. Patients must not have a prior or concurrent malignancy whose natural history or treatment has the potential (in the opinion of the treating physician) to interfere with the safety or efficacy assessment of the investigational regimen.