NCT04325763

A Study of TQB2450 in Subjects With Stage III Non-Small Cell Lung Cancer(NSCLC)

A Randomized, Double-blind and Imitation, Placebo Parallel Control, Multicentre Phase III Study of TQB2450 With or Without Anlotinib as Consolidation Treatment in Subjects With Locally Advanced/Unresectable (Stage III) Non-Small Cell Lung Cancer That Have Not Progressed After Prior Concurrent/Sequential Chemoradiotherapy

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 315 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized, double-blind, double-dummy,placebo parallel controlled, multi-centre,phase III clinical trial to evaluate the efficacy and safety of TQB2450 with or without anlotinib compared with placebo as consolidation treatment in subjects with locally advanced/unresectable (Stage III) Non-Small Cell Lung Cancer that has not progressed after prior concurrent/sequential chemoradiotherapy.

Conditions

• Stage III Non-small-cell Lung Cancer

Interventions

Type	Name	Description
DRUG	TQB2450	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 T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.
DRUG	Anlotinib	a multi-target receptor tyrosine kinase inhibitor
DRUG	TQB2450(blank)	Subjects administrated TQB2450 (blank) intravenously (IV) on Day 1 of each 21-day
DRUG	Anlotinib(blank)	Subjects administrated anlotinib (blank) in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)

Timeline

• Start date: 2020-05-27
• Primary completion: 2022-12-01
• Completion: 2025-03-01
• First posted: 2020-03-30
• Last updated: 2022-03-31

Locations

36 sites across 1 country: China