SBRT Combined With Avelumab (Anti-PD-L1) for Management of Early Stage Non-Small Cell Lung Cancer (NSCLC)

Inclusion Criteria:

* Tumor(s) to be treated is(are) ≤ 5.0 cm or ≤250 cm3
* Stage I NSCLC and is deemed medically inoperable or refuses surgical resection.
* Life expectancy ≥ 9 months.
* Acceptable organ and marrow function

Exclusion Criteria:

* Prior organ transplantation, including allogeneic stem cell transplantation
* Significant acute or chronic infections including:

  * Known history of human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
  * Known history of HBV or HCV
* Active autoimmune disease

  * Subjects with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible.
  * Subjects requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses ≤ 10 mg or 10 mg equivalent prednisone per day
  * Administration of steroids through a route known to result in a minimal systemic exposure (topical, intranasal, intro-ocular, or inhalation) are acceptable
* Current use of immunosuppressive medication, EXCEPT for the following:

  * intranasal, inhaled, topical steroids, or local steroid injection (eg, intra-articular injection)
  * Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent
  * Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication).
* Cardiovascular disease: cerebral vascular accident/stroke (\< 6 months prior to enrollment), myocardial infarction (\< 6 months prior to enrollment), unstable angina, congestive heart failure, or serious cardiac arrhythmia requiring medication.
* Known severe hypersensitivity reactions to monoclonal antibodies any history of anaphylaxis, or uncontrolled asthma
* Pregnancy or lactation
* Known alcohol or drug abuse
* Prior radiotherapy to the treatment site(s).