NCT05718167

TQB2450 Injection Combined With Chemotherapy Followed by Sequential Combination With Anlotinib Hydrochloride Capsule for First-line Treatment of Advanced Squamous Non-small Cell Lung Cancer.

A Phase 3, Randomized, Double-blind, Parallel Controlled, Multi-center Study to Compare the Safety and Efficacy of TQB2450 Injection Combined With Paclitaxel Injection and Carboplatin Injection Followed by TQB2450 Injection Combined With Anlotinib Hydrochloride Capsules Versus Tislelizumab Injection Combined With Paclitaxel Injection and Carboplatin Injection Followed by Tislelizumab Injection as a First-line Treatment on Patient With Advanced Squamous NSCLC.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 570 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is Phase 3, randomized, double-blind, parallel controlled study designed to evaluate the Progression Free Survive (PFS) of TQB2450 injection combined with Paclitaxel Injection and Carboplatin Injection Followed by TQB2450 injection combined with Anlotinib Hydrochloride Capsules versus Tislelizumab injection combined with Paclitaxel Injection and Carboplatin Injection followed by Tislelizumab injection in locally advanced (stage ⅢB/ⅢC) and metastatic or recurrent (Stage IV) squamous NSCLC subjects.The primary endpoint is PFS assessed by IRC.

Conditions

• Advanced Squamous Non-Small Cell Lung Carcinoma

Interventions

Type	Name	Description
DRUG	TQB2450	TQB2450 is a humanized monoclonal antibody targeting the programmed death ligand 1 (PD-L1), which prevents PD-L1 from binding to the PD-1 and B7.1 receptors on the surface of T cells, making T cells recover their activity, thereby enhancing the immune response.
DRUG	Anlotinib hydrochloride capsule	Anlotinib hydrochloride is a multi-target receptor tyrosine kinase inhibitor, which can target angiogenesis related kinases, such as VEGFR 1/2/3, FGFR 1/2/3 and other tumor cell proliferation related kinases like Platelet-derived growth factor receptor (PDGFR) α/β、 C-kit, RET.
DRUG	Tislelizumab injection	Tislelizumab injection can bind to human programmed cell death 1 (PD-1), a cell membrane protein that is mainly expressed on activated T cells and inhibits T cell activation.

Timeline

• Start date: 2023-02-01
• Primary completion: 2024-10-01
• Completion: 2025-10-01
• First posted: 2023-02-08
• Last updated: 2023-02-14

Locations

4 sites across 1 country: China