from The New England Journal of Medicine
Dr. Kellie Smith, recipient of an LCFA/IASLC 2016 Lori Monroe Scholarship in Translational Lung Cancer Research, along with her research team, outlines their study supported in part by the grant from Lung Cancer Foundation of America
Needs Assessment
Methods
PATIENTS
Eligible patients were 18 years of age or older and had stage I, II, or IIIA NSCLC that was deemed to be surgically resectable before enrollment. All the patients had an Eastern Cooperative Oncology Group performance-status score of 0 or 1 (on a 5-point scale in which higher numbers reflect greater disability), normal organ function, and adequate pulmonary function. Key exclusion criteria were immunodeficiency, ongoing systemic immunosuppressive therapy, active autoimmune or infectious disease, and clinically significant concurrent cancer.
STUDY DESIGN
This single-group study was developed by the authors and conducted at two medical centers in the United States. The patients received two doses of intravenous nivolumab (at a dose of 3 mg per kilogram of body weight) every 2 weeks. It was planned that surgery would be performed approximately 4 weeks after the first dose. All the patients provided written informed consent.
The primary end points were safety and feasibility. The key secondary and exploratory end points were radiologic and pathological responses to treatment and immunologic, genomic, and pathological correlates of response in blood and tumor.
All the patients were monitored for adverse events, according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0. Feasibility was prospectively defined as any delay in the planned surgery of no more than 37 days (i.e., a surgical delay of >30 days and 7 days for scheduling). In a safety run-in phase, an initial 6 patients were followed for perioperative adverse events of grade 3 or 4 for 90 days after the administration of the last nivolumab dose (or day 30 after surgery). With the goal of exploring the antitumor immune response in depth, the study then expanded to enroll a total of 20 patients who underwent complete tumor resection.