Single-center phase 2 trial of sintilimab-based induction therapy in potentially resectable stage III non-small cell lung cancer

Approximately 30% of patients with non-small cell lung cancer have initially resectable disease. The phase 2 LungMate-009 trial at Tongji University School of Medicine (Shanghai, China) evaluated sintilimab-based induction therapy for potentially resectable stage III NSCLC. Eligible patients with PD-L1 expression in at least 50% of the tumor cells received neoadjuvant sintilimab monotherapy (four cycles 200 mg every 3 weeks); patients with PD-L1 expression in less than 50% of tumor cells received four cycles of sintilimab in combination with carboplatin-based chemotherapy. Surgical resection was performed within 21-28 days of the last dose. The primary endpoint was major pathological response rate. A total of 75 of 97 patients (77%) complete four cycles of neoadjuvant treatment. An overall response was observed in 80 patients (82%; 95% CI 75-90). Surgery was performed in 58 patients (60%), and all patients had R0 resection. Thirty-eight (66%; 95% CI 53-78) of 58 patients had a majro pathological response. Median progression-free survival and overall survival were not reached after median follow-up duration of 31.0 months (IQR 27.5-32.6). Grade 3 or higher treatment-related adverse events occurred in 40 (41%) of 97 patients. The authors conclude that sintilimab-based induction therapy could be an option for patients with potentially resectable stage III NSCLC.