Three‐Year Follow‐Up of the Phase II Trial for Resectable Non‐Small‐Cell Lung Cancer Treated With Perioperative Sintilimab and Neoadjuvant Anlotinib Plus Chemotherapy: TD‐NeoFOUR Trial

ABSTRACT Background Lung cancer is a leading cause of cancer‐related deaths. Perioperative therapies, including neoadjuvant chemo‐immunotherapy, have improved outcomes, but combining them with antiangiogenic drugs may offer further benefits. This study evaluated the 3‐year efficacy and safety of neoadjuvant sintilimab, anlotinib, and chemotherapy in resectable NSCLC patients from the TD‐NeoFOUR trial. Methods The study included 45 patients who received neoadjuvant treatment with anlotinib, sintilimab, and platinum‐based chemotherapy. The primary endpoint was overall survival (OS), and the secondary endpoint was event‐free survival (EFS). The Kaplan–Meier method was used to estimate survival curves, and the log‐rank test was used to compare survival rates between subgroups. Results As of November 11, 2024, all 45 patients had been followed up for a median of 35.7 months. The estimated 3‐year EFS rate was 84.3%, and the estimated 3‐year OS rate was 86.7%. Subgroup analysis showed that patients achieving pathological complete response (pCR) and major pathological response (MPR) had significantly higher 3‐year EFS and OS rates compared to patients with non‐pCR and non‐MPR. No new treatment‐related adverse events (TRAEs) occurred during the 3‐year follow‐up, indicating the long‐term safety of the treatment regimen. Conclusions The combination of neoadjuvant chemo‐immunotherapy and antiangiogenic drugs significantly improved long‐term survival outcomes in patients with resectable NSCLC. This treatment regimen is a promising option for improving prognosis in this patient population.