NCT05859373

To Evaluate the Efficacy and Safety of TQB3728 Tablets in Sequential Maintenance of TQB2450 Injection Therapy in Patients After Sequential or Concurrent Chemoradiation for Locally Advanced Non-small Cell Lung Cancer.

A Randomized, Open Label, Parallel Controlled, Multicenter Phase Ib/II Clinical Trial to Evaluate the Efficacy and Safety of TQB3728 Tablets in Sequential Maintenance of TQB2450 Injection Therapy in Patients After Sequential or Concurrent Chemoradiation for Locally Advanced Non-small Cell Lung Cancer.

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

It's a Phase Ib/II clinical trial to evaluate the efficacy and safety of TQB3728 tablets in sequential maintenance TQB2450 injection therapy in patients after sequential or concurrent chemoradiation for locally advanced non-small cell lung cancer. Incidence and severity of adverse events (AEs), the type of dose-limiting toxicity(ies) (DLT\[s\]) and Recommended phaseII dose(RP2D) were the Phase Ib primary endpoint. Overall response rate (ORR) was the Phase II primary endpoint.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	TQB3728 tablets, TQB2450 injection, sequential or concurrent chemoradiation	TQB3728 is an inhibitor of apoptosis protein. TQB2450 injection is humanized monoclonal antibody to Programmed Cell Death Protein 1 (PD-1).
COMBINATION_PRODUCT	TQB3728 tablets, TQB2450 injection, sequential or concurrent chemoradiation	TQB3728 is an inhibitor of apoptosis protein. TQB2450 injection is humanized monoclonal antibody to Programmed Cell Death Protein 1 (PD-1).
COMBINATION_PRODUCT	TQB2450 injection, sequential or concurrent chemoradiation	TQB2450 injection is humanized monoclonal antibody to Programmed Cell Death Protein 1 (PD-1).

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-09-01
• Completion: 2024-12-01
• First posted: 2023-05-16
• Last updated: 2023-05-16

Locations

1 site across 1 country: China