NCT05922345

Evaluation of the Efficacy and Safety of AL2846 Capsule Combined With TQB2450 Injection Compared to Docetaxel Injection in Advanced Non-small Cell Lung Cancer Patients Who Have Failed With Immunotherapy.

A Multicenter, Randomized, Double-blind, Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of AL2846 Capsules Combined With TQB2450 Injection Compared With Docetaxel Injection in Patients With Advanced Non-small Cell Lung Cancer Who Have Failed With Immunotherapy.

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 518 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To investigate the efficacy of AL2846 capsules in combination with TQB2450 injection or Docetaxel injection in patients with advanced NSCLC who have previously failed immune checkpoint inhibitors (anti-PD-1 monoclonal antibody, anti-PD-L1 monoclonal antibody), regardless of new anti-tumor treatment and early termination of treatment.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	TQB2450 injection, docetaxel injection matching placebo, AL2846 capsules	AL2846 capsules is a multi-targeted small molecule receptor tyrosine kinase inhibitor. TQB2450 Injection is an anti-programmed death-1 (PD-L1).
DRUG	TQB2450 placebo, docetaxel injection, AL2846 matching placebo	Docetaxel injection is a type of chemotherapy for treatment of different types of cancer.

Timeline

• Start date: 2023-06-08
• Primary completion: 2025-08-01
• Completion: 2025-12-01
• First posted: 2023-06-28
• Last updated: 2024-12-30

Locations

71 sites across 1 country: China