Stereotactic Body Radiation Therapy (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).