Phase II Study of TQB2450 Injection With Anlotinib and Chemotherapy for Advanced Non-small Cell Lung Cancer After First-Line Immunotherapy Failure

What this Trial Is About

Researchers are comparing the safety and effectiveness of TQB2450 injection combined with anlotinib and chemotherapy versus TQB2450 injection combined with chemotherapy alone in people with advanced non-small cell lung cancer NSCLC who have not responded to first-line chemotherapy combined with immunotherapy. The study also aims to explore biomarkers related to treatment effectiveness, mechanisms of action or resistance, and safety. This is a randomized, double-blind, phase II clinical trial conducted by Tianjin Medical University Cancer Institute and Hospital. Participants receive treatment every three weeks. One group receives TQB2450 1200 mg intravenously on day 1, anlotinib oral capsules on days 1 to 14, and docetaxel chemotherapy 60 mg per square meter intravenously on day 1. The other group receives TQB2450 and docetaxel chemotherapy with a placebo instead of anlotinib. Treatment is given in cycles of three weeks. During the study, participants will be monitored through various assessments including tumor measurements to evaluate progression-free survival up to 48 weeks. Other outcomes include overall response rate, disease control rate, overall survival, and duration of response. Safety and tolerability will be closely observed. The total duration of participation varies, with follow-up continuing until disease progression or death.

Phase II Clinical Trial to Evaluate the Safety and Efficacy of TQB2450 Injection Combined With Anlotinib Capsule and Chemotherapy in the Treatment of Immunoresistant Advanced Non-small Cell Lung Cancer