NCT05346952

A Study of TQB2450 Injection Plus Chemotherapy Followed by TQB2450 Plus Anlotinib Versus Tislelizumab Plus Chemotherapy Followed by Tislelizumab in the Treatment of First-line Non-squamous Non-small Cell Lung Cancer(NSCLC).

A Phase 3，Randomized，Open，Parallel Controlled, Multi-center Study of TQB2450 Injection Plus Chemotherapy Followed by TQB2450 Plus Anlotinib Versus Tislelizumab Plus Chemotherapy Followed by Tislelizumab as a First-line Treatment on Patient With Advanced Non-squamous NSCLC

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 390 (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, open-label, parallel controlled study designed to compare the efficacy and safety of TQB2450 in combination with platinum-containing chemotherapy followed by TQB2450 plus Anlotinib versus tislelizumab in combination with platinum-containing chemotherapy followed by tislelizumab in locally advanced (stage ⅢB/ⅢC), metastatic or recurrent ( Stage IV) non-squamous NSCLC cancer. The primary endpoint is Progression Free Survival (PFS) assessed by IRC.

Conditions

• Advanced Non-squamous Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	TQB2450 injection, Tilelizumab injection, Anlotinib hydrochloride capsule, Pemetrexed disodium injection, Carboplatin injection	PD-L1(programmed cell death-Ligand 1) may be expressed on tumor cells and/or tumor-infiltrating immune cells, which can inhibit the anti-tumor immune response in the tumor microenvironment. On T cells and antigen-presenting cells, PD-L1 binding to PD-1 (programmed cell death-1) and B7.1 receptors inhibits cytotoxic T cell activation, T cell proliferation, and cytokine production.

Timeline

• Start date: 2022-01-25
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2022-04-26
• Last updated: 2022-04-26

Locations

1 site across 1 country: China