Study of TQB2450 Injection with Chemotherapy or Anlotinib Capsule for Treating Resectable Stage IIIII Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of TQB2450 injection combined with chemotherapy or anlotinib hydrochloride capsule in the perioperative treatment of resectable stage IIIII non-small cell lung cancer. This phase 2 clinical study involves patients eligible for curative surgery and aims to improve treatment outcomes using these combination therapies. The study is sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Participants are randomly assigned to one of two treatment groups. In the first group, patients receive 3 to 4 cycles of TQB2450 combined with chemotherapy every 21 days, followed by surgery 4 to 6 weeks after the last dose. TQB2450 treatment continues for one year after surgery. In the second group, participants receive 4 cycles of TQB2450 combined with 3 cycles of anlotinib hydrochloride capsule over 21-day cycles, followed by surgery 4 to 6 weeks after the last dose, with treatment continuing for one year starting 4 weeks after surgery. During the study, participants undergo tumor tissue testing for PD-L1 and regular assessments including measuring major pathologic response up to 60 months. Secondary outcomes include overall survival, event-free survival, disease-free survival, pathological complete response, and surgical outcomes, with follow-up extending up to 60 months. Patients are monitored for safety, treatment effects, and surgery timing. The total participation time may last several years to evaluate long-term results.

A Clinical Study of TQB2450 Injection Combined With Chemotherapy or Anlotinib Hydrochloride Capsule in the Treatment of Non Small Cell Lung Cancer