ABOUT THIS STUDY
- 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
- 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,
- Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or
- Steroids as premedication for hypersensitivity reactions (eg, CT scan
- 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).
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