Avelumab and Stereotactic Body Radiation Therapy in Treating Patients with Stage I Non-small Cell Lung Cancer

Inclusion Criteria

• Patient’s tumor(s) to be treated is(are) =< 5.0 cm or =< 250 cm^3
• Patient must have stage I NSCLC and is not undergoing surgical resection; only patients who are deemed medically inoperable or refuse surgery after thoracic surgery consultation will be eligible
• Histological confirmation of malignancy (primary tumor)
• Patient must have a life expectancy >= 9 months
• Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status =< 2
• Absolute neutrophil count >= 1.5 x 10^9/L
• Platelets >= 100 x 10^9/L
• Total bilirubin < 1.5 x institutional upper limit of normal
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) < 2.5 X institutional upper limit of normal
• Estimated creatinine clearance >= 60 mL/min according to the Cockcroft-Gault formula (or local institutional standard method)
• Pulse oximetry >= 92% on room air at rest
• Hemoglobin >= 10.0 g/dL
• Negative serum pregnancy test at screening for women of childbearing potential
• Highly effective contraception for both male and female subjects if the risk of conception exists; (Note: the effects of the trial drug on the developing human fetus are unknown; thus, women of childbearing potential and men able to father a child must agree to use 2 highly effective contraception, defined as methods with a failure rate of less than 1 % per year; highly effective contraception is required at least 28 days prior, throughout and for at least 60 days after avelumab treatment
• Patient must have the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

• Prior organ transplantation, including allogeneic stem cell transplantation
• Significant acute or chronic infections including, among others: * Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) * Known history of testing positive for hepatitis B virus (HBV) surface antigen and/or confirmatory hepatitis C virus (HCV) ribonucleic acid (RNA) (if anti-HCV antibody tested positive)
• Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent: * 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: a. intranasal, inhaled, topical steroids, or local steroid injection (eg, intra-articular injection); b. systemic corticosteroids at physiologic doses =< 10 mg/day of prednisone or equivalent; c. steroids as premedication for hypersensitivity reactions (eg, computed tomography [CT] scan premedication)
• Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (>= New York Heart Association Classification class II), or serious cardiac arrhythmia requiring medication
• Known severe hypersensitivity reactions to monoclonal antibodies (grade >= 3 National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.03), any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma)
• Persisting toxicity related to prior therapy of grade > 1 NCI-CTCAE v 4.03; however, alopecia and sensory neuropathy grade =< 2 is acceptable
• Pregnancy or lactation
• Known active alcohol or drug abuse
• All other significant diseases (for example, colitis, pneumonitis, pulmonary fibrosis, inflammatory bowel disease, uncontrolled asthma), which, in the opinion of the Investigator, might impair the subject’s tolerance of trial treatment
• Any psychiatric condition that would prohibit the understanding or rendering of informed consent
• Vaccination within 4 weeks of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines
• Patient who has had any prior radiotherapy to the treatment site(s)
• Patient refuses to sign informed consent