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RECRUITING
NCT05913089
PHASE2

A Clinical Study of TQB2450 Injection Combined With Chemotherapy or Anlotinib Hydrochloride Capsule in the Treatment of Non Small Cell Lung Cancer

Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a clinical study on the efficacy and safety of TQB2450 injection combined with chemotherapy or anlotinib hydrochloride capsule in the perioperative treatment of resectable non-small cell lung cancer. The part I study was planned to enroll 58 subjects, 1:1 randomized into two cohorts. The treatment regimen was as follows: Cohort 1: 3-4 cycles of TQB2450 combined with chemotherapy, surgery should be performed 4-6 weeks after the last administration, and TQB2450 therapy should be continued for 1 year after surgery. Cohort 2: 4 cycles of TQB2450 combined with 3 cycles of anlotinib hydrochloride capsule. Surgery was performed 4-6 weeks after the last dose and continued for 1 year starting 4 weeks after surgery.

Official title: A Phase II/III Clinical Study on the Efficacy and Safety of TQB2450 Injection Combined With Chemotherapy or Anlotinib Hydrochloride Capsule in the Perioperative Treatment of Resectable Stage II/III Non Small Cell Lung Cancer.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

58

Start Date

2023-06-14

Completion Date

2026-12

Last Updated

2023-06-29

Healthy Volunteers

No

Interventions

DRUG

TQB2450 injection + Chemotherapy

TQB2450 injection is a humanized monoclonal antibody targeting programmed death ligand -1 (PD-L1). Chemotherapy is a systematic treatment that kill fast growing cells.

DRUG

TQB2450 injection + Anlotinib Hydrochloride Capsule

TQB2450 injection is a humanized monoclonal antibody targeting programmed death ligand -1 (PD-L1). Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor.

Locations (10)

Cancer Hospital of Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Beijing Chaoyang Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Beijing Chest Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Weifang People's Hospital

Weifang, Shandong, China

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Shanxi Cancer Hospital

Taiyuan, Shanxi, China

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Tianjin Chest Hospital

Tianjin, Tianjin Municipality, China