Phase II Study of Canakinumab to Prevent Lung Cancer in Patients with High-Risk Pulmonary Nodules

What this Trial Is About

This trial focuses on patients with high-risk pulmonary nodules who may be at risk of developing lung cancer. The study evaluates the effects of canakinumab, a monoclonal antibody, on preventing lung cancer by increasing regression rates of these nodules and prolonging lung cancer-free survival. The trial is a phase II study aimed at assessing canakinumabs potential preventive role and its safety and impact on quality of life. Participants receive canakinumab through subcutaneous injections on day 1, repeated every 21 days for up to 8 cycles, as long as there is no disease progression or unacceptable side effects. After treatment, participants are followed for 30 days and then at 6, 12, and 24 weeks to monitor outcomes. This includes assessing lung cancer occurrence, nodule regression, and quality of life. During the trial, participants undergo regular evaluations including imaging studies to monitor nodules, laboratory tests to assess safety, and quality of life questionnaires at baseline and after 24 weeks. Researchers measure the regression of indeterminate pulmonary nodules, track lung cancer-free survival, and document any adverse events. Follow-up visits allow for ongoing monitoring of health status and treatment effects over several months.

Canakinumab for the Prevention of Lung Cancer, the Can-Prevent-Lung Trial