SABR-ATAC: A Trial of TGF-beta Inhibition and Stereotactic Ablative Radiotherapy for Early Stage Non-small Cell Lung Cancer

Inclusion Criteria:

   - Newly diagnosed, histologically proven (or strongly suspected, see below) T1-T2aN0M0
   (Stage IA-IB) non-small cell lung cancer (NSCLC), with maximum tumor diameter =< 5 cm
   under consideration for stereotactic ablative body radiotherapy (SABR) as definitive
   primary treatment

   - Patient judged to be inoperable or at high surgical risk by a board qualified thoracic
   cancer surgeon who has evaluated the subject within the prior 12 weeks, or the
   patient's case has been discussed at a multidisciplinary tumor board with a thoracic
   cancer surgeon in attendance, or a patient who refuses surgery or declines to be
   evaluated for surgery.

   - Able to give informed consent

   - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2

   - Men or women of child bearing potential must agree to use an acceptable method of
   birth control (hormonal or barrier method of birth control; abstinence) to avoid
   pregnancy for at least 90 days after last study treatment (radiation or fresolimumab)

Exclusion Criteria:

   - Significant anemia (hemoglobin below 9.0 g/dL) or neutropenia (absolute neutrophil
   count [ANC] < 1000/mm^3)

   - Prior history of multifocal adenocarcinoma in situ (ie, classic or pure
   bronchioloalveolar carcinoma)

   - Prior history of keratoacanthoma (well differentiated squamous cell skin cancer
   variant, often centrally ulcerated); history of basal cell cancer is allowed

   - Pre malignant skin lesion(s) noted on prescreening skin exam, except for actinic
   (solar) keratosis

   - Prior radiotherapy overlapping with high dose region of planned SABR course

   - Prior history of head and neck; oral; or bladder cancer

   - Prior receipt of systemic treatment (chemotherapy, targeted therapy, or immunotherapy)
   for the lesion under consideration of treatment

   - Uncontrolled, inter current or recent illness that in the investigator's opinion
   precludes participation in the study, including those undergoing therapy for a
   separate invasive malignancy

   - Contraindication to receiving radiotherapy

   - Known allergy to components of fresolimumab

   - Pregnant or breastfeeding. All women of child bearing potential (last menstrual period
   within the previous 12 months and not surgically sterile) will be tested for pregnancy
   at pre entry.