Patient eligibility
NSCLC, hepatitis B, autoimmune disorders, infections, human immunodeficiency virus, hepatitis, Cancer
HEPATITIS B, RECURRENCE, CARDIOVASCULAR DISEASE, HUMAN IMMUNODEFICIENCY VIRUS, AUTOIMMUNE DISORDERS, INFECTIONS, MALIGNANCIES, NSCLC, IDIOPATHIC PULMONARY FIBROSIS, HEART, HEPATITIS, CANCER
The study was authorized and approved by the IRB of, and patients were recruited from three centers: The University of California Davis Comprehensive Cancer Center, Cedars Sinai Medical Center, and VA David Grant Medical Center. The study design and conduct complied with all relevant regulations regarding the use of human study participants and was conducted in accordance with the criteria set by the Declaration of Helsinki. All patients provided written informed consent prior to any study procedures. The trial was registered on clinicaltrials.gov (NCT02599454). The first patient was enrolled on 5/3/2016, and the last patient was enrolled on 8/9/2019. Eligible patients were ≥18 years of age with histologically confirmed T1-3 NSCLC ≤ 7 cm diameter. Although patients with EGFR or ALK mutations would not be expected to respond to ICI based on data from advanced NSCLC, these patients were not excluded since there is limited tissue available for NGS testing in this population. Patients with chest wall invasion (T3) and 2 nodules within the same lobe of the lung were eligible. Patients were required to have one or more features predictive of increased recurrence risk: diameter ≥1 cm for the phase I component and ≥2 cm for the expansion cohort; SUV ≥ 6.2 on FDG PET; or moderately/poorly differentiated histology. Patients were required to be either medically inoperable as determined by multidisciplinary evaluation or to have refused surgery, had a forced expiratory volume over 1 s (FEV1) ≥ 700 cc, and a diffusing capacity for carbon monoxide (DLCO) ≥ 5.5 m/min/mm Hg on pulmonary function testing (PFT), and had a Zubrod performance status (PS) ≤ 2. Exclusion criteria included New York Heart Association class II or greater cardiovascular disease, severe infections within 4 weeks of enrollment, history of autoimmune disorders, idiopathic pulmonary fibrosis, and active human immunodeficiency virus, hepatitis B, or hepatitis C. Prior malignancies did not disqualify as long as they were not active at the time of enrollment. Required staging workup included PFTs within 3 months of registration and computed tomography (CT) of the chest within 28 days of registration. PET/CT staging was not mandated but was encouraged.