Fresolimumab and Stereotactic Ablative Radiotherapy in Treating Patients with Stage IA-IB Non-small Cell Lung Cancer

Inclusion Criteria

• Newly diagnosed, histologically proven (or strongly suspected, see below) T1-T2aN0M0 (stage IA-IIA) 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 within 12 weeks
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2
• Able to give informed consent
• 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