Safety Study of a Peptide Vaccine to Prevent Resistance in Advanced ALK-Positive Lung Cancer Patients on Targeted Therapy

What this Trial Is About

Researchers are evaluating the safety of a cancer peptide vaccine designed to prevent or delay acquired resistance in patients with advanced ALK-positive non-small cell lung cancer NSCLC who are currently undergoing ALK targeted therapy. This study focuses on advanced stage IV NSCLC patients with documented ALK rearrangement and aims to monitor treatment-related adverse events and immune responses over time. Participants will receive the peptide vaccine as the study intervention. All patients enrolled will be treated with this vaccine while continuing their current ALK targeted therapy, such as crizotinib, ceritinib, alectinib, brigatinib, or lorlatinib, provided they have stable disease for at least four months. The study does not include a placebo group, and the vaccine is administered throughout the treatment period. During the study, participants will be monitored for any adverse events related to the vaccine as well as the vaccine-specific immune response for up to two years. Researchers will conduct regular assessments to evaluate the safety and immune effects of the vaccine. The total participation time may extend until study completion, with ongoing follow-up to ensure safety and measure outcomes related to the vaccines impact.

Peptide Vaccine To Prevent Acquired Resistance In Patients With Advanced ALK+ NSCLC