Abstract
OBJECTIVE: This study assessed the safety and efficacy of rechallenging patients in advanced non-small cell lung cancer (NSCLC) without targetable driver mutations using a combination of immune checkpoint inhibitors (ICIs) and anlotinib following progression after prior immunotherapy. METHODS: A retrospective analysis was performed on 14 patients who received rechallenge with ICIs combined with anlotinib at the First Affiliated Hospital of Guangzhou University of Chinese Medicine. China, between March 2020 and June 2024. RESULTS: The study observed an objective response rate of 28.6% and a disease control rate of 92.9%. The median progression-free survival (PFS) was 11.7 months, with programmed death-ligand 1 (PD-L1)-positive patients demonstrating significantly longer PFS (13.0 months) compared with PD-L1-negative or unknown patients (10.3 months, P = 0.048). Toxicity was manageable, with most adverse events being mild to moderate in severity. Only one case (7.1%) of grade 3 adverse events was reported, and no treatment-related fatalities occurred. CONCLUSION: ICIs combined with anlotinib as a rechallenge therapy exhibited promising efficacy and an acceptable safety profile in patients with advanced NSCLC without targetable driver mutations. These findings suggest a potential treatment option for patients with post-immunotherapy progression.