ObjectiveChemotherapy-based regimens remain the standard first- and second-line treatment options for patients with driver gene-negative non-small cell lung cancer (NSCLC). However, in real-world settings, certain patients cannot tolerate chemotherapy or opt to decline it. Immune checkpoint inhibitors (ICIs) constitute the preferred chemotherapy-free alternative. To enhance patient prognosis, this study aimed to examine the efficacy of ICIs combined with anlotinib in real-world scenarios.MethodsThis prospective, multicenter, real-world study evaluated the efficacy and safety of ICIs combined with anlotinib in patients with advanced NSCLC. Patients undergoing first- or second-line treatment were enrolled. The primary endpoint was progression-free survival (PFS), while the secondary endpoints included overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety.ResultsIn total, 242 patients were enrolled from 28 centers. The median PFS for the entire cohort was 7.8 95% confidence interval (95% CI), 7.0−9.5 months, OS events occurred in 112 (46.3%) patients, with a current median OS of 17.0 (95% CI, 15.1−19.4) months. The ORR and DCR were 36.0% (95% CI, 30.2%−42.2%) and 97.9% (95% CI, 95.3%−99.1%), respectively. The median PFS was 9.8 (95% CI, 7.4−12.5) months for first-line therapy and 6.9 (95% CI, 6.0−8.3) months for second-line therapy. Treatment-related adverse events (AEs) occurred in 198 (81.8%) patients, with grade 3−4 AEs reported in 22 (9.1%) patients.ConclusionsThis multicenter, real-world study demonstrates that the anlotinib-ICI combination regimen exhibits clinically meaningful efficacy and tolerability as a chemotherapy-free alternative for advanced NSCLC, offering viable evidence to guide treatment for patients who are unsuitable for conventional chemotherapy.
Haiyang et al. (2026) studied this question.