NCT06141226

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

Randomized, Double-blind, Parallel Controlled, Multicenter Phase II Clinical Trial to Evaluate the Safety and Efficacy of TQB2450 Injection Combined With Arotinib Capsules and Chemotherapy in the Treatment of Advanced Non-small Cell Lung Cancer After Immune Resistance

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 148 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Objective to compare the efficacy and safety of TQB2450 injection combined with anlotinib and chemotherapy, and TQB2450 injection combined with chemotherapy in the treatment of advanced non-small cell lung cancer subjects who failed to receive first-line chemotherapy combined with immunization, and to explore and evaluate biomarkers related to efficacy, mechanism of action / resistance mechanism, and safety.

Conditions

• Non-small-cell Lung Cancer

Interventions

Type	Name	Description
DRUG	TQB2450 +Anlotinib+Docetaxel	TQB2450 is a humanized monoclonal antibody targeting programmed death ligand 1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on the surface of T cells, restoring T cell activity and enhancing immune response. It has the potential to treat various types of tumors. Anlotinib is a multi target receptor tyrosine kinase (RTK) inhibitor. It can inhibit VEGFR1, VEGFR2, VEGFR3, c-Kit, PDGFR β Activity. Docetaxel is a taxane based anti-tumor drug.
DRUG	TQB2450 +Androtinib Placebo+Docetaxel	TQB2450 is a humanized monoclonal antibody targeting programmed death ligand 1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on the surface of T cells, restoring T cell activity and enhancing immune response. It has the potential to treat various types of tumors. Androtinib Placebo Docetaxel is a taxane based anti-tumor drug.

Timeline

• Start date: 2023-04-12
• Primary completion: 2027-12-30
• Completion: 2028-12-30
• First posted: 2023-11-21
• Last updated: 2024-09-19

Locations

5 sites across 1 country: China