IR-guided Ablation (IRGA) Combined With Stereotactic Ablative Radiation (SABR) for Lung Tumors Larger Than 3 cm: Phase I Dose Escalation and Pilot Study With Companion Biomarker Analysis

Inclusion Criteria:

- Pathological (histologically or cytologically) diagnosis of non-small cell lung
cancer (NSCLC); or if lung tumor is considered to be metastases (even from primary
NSCLC), then clinical diagnosis is sufficient

- For NSCLC: Staging workup at initial diagnosis demonstrates T2-T4N0M0, or
T2-T4,N1-3,M1; node-positive patients will be allowed on study only if they have M1
disease; clinical diagnosis of M1 disease is sufficient

- Patient is deemed (a) to be medically inoperable after evaluation by thoracic surgeon
based on, but not limited to the following: baseline forced expiratory volume in one
second (FEV1) < 40% predicted, post-operative FEV1 < 30% predicted, severely reduced
diffusion capacity, baseline hypoxemia/hypercapnia, coronary artery disease,
end-organ damage, or (b): patient has refused surgery after thoracic surgery
consultation

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

- NSCLC only: pleural effusion, if present, will undergo routine assessment for
malignancy; inability to obtain fluid or non-diagnostic cytology will not preclude
eligibility

- Negative serum or urine pregnancy test within 4 weeks prior to registration in women
with childbearing potential

- Able to provide written, informed consent

- Minimum of 4 weeks from last dose of chemotherapy to start of treatment

Exclusion Criteria:

- For NSCLC only: prior invasive malignancy (except non-melanoma skin cancer) unless
disease-free for a minimum of 2 years, including previous history of lung cancer

- Prior radiation to the region of current cancer that would result in > 50% overlap of
the old treatment field on the new treatment area based on radiation oncologist
evaluation

- International normalization ratio (INR) of > 1.5

- Platelets of < 50,000 /uL

- Inability to meet maximum point dose constraints