Adebrelimab in combination with anlotinib and chemotherapy as neoadjuvant therapy for resectable stage II-III non–small cell lung cancer (NSCLC): A prospective, single-arm, phase II trial.

Abstract

e20073 Background: Immunotherapy combined with chemotherapy as neoadjuvant treatment for NSCLC has demonstrated significant clinical benefits, yet various treatment regimens continue to be explored during neoadjuvant therapy for resectable NSCLC. We report here the efficacy and safety of adebrelimab combined with anlotinib and chemotherapy in neoadjuvant treatment for stage II-III NSCLC. Methods: Eligible patients (pts) were resectable stage II and III (IIIA and T3N2M0 IIIB) NSCLCs without EGFR/ALK/ROS1 alterations. Patients received neoadjuvant treatment with adebrelimab＋anlotinib , 4 cycles and chemotherapy 3-4 cycles, followed by surgical resection.The primary endpoint was major pathological response (MPR), secondary endpoints inluding pathological complete response rate (pCR), objective response rate (ORR), event free survival (EFS), overall survival (OS), and safety (NCI-CTCAE v5.0). Results: From March 2025 to January 2026, 44 pts was screened and 37 eligible pts enrolled. 81.1% were male, 62.2% had squamous cell carcinoma, 78.4% of pts had a history of smoking, and 75.7% were stage III pts. As of January 24, 2026, all 37 pts received at least one cycle of neoadjuvant therapy, with 28 pts completed the full four-cycle regimen. Surgery was performed in 25 pts (1 pts refused surgery, 1 pts withdrew informed consent, and1 pts died unexpectedly), 100% achieved R0 resection. Pathological assessment was completed in 25 patients, demonstrating pCR in 14 (56.0%) and MPR in 18 (72.0%). 34 pts had an objective response per RECIST v1.1, including 6 with complete response and 17 with partial response. The ORR was 67.6% and DCR was 97.1%. 35 pts were included in the safety analysis. Grade ≥3 treatment-related adverse events included thrombocytopenia (11.4%), lymphopenia (8.6%) and leukopenia (5.7%). One patient died due to an accidental fall. No surgical delays occurred due to adverse events. No deaths related to tumor treatment were identified. Conclusions: Adebrelimab in combination with anlotinib and chemotherapy as neoadjuvant therapy showed a high proportion of MPR and pCR for resectable stage II-III NSCLC, and the safety profile was well tolerated. Future clinical studies with larger sample sizes are needed to be validated. Clinical trial information: ChiCTR2500100571.