Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

All Drugs and Chemicals

Amino Acids

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Tyrosine Kinase Inhibitors

Tyrosine

TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle ,Anlotinib capsules 8 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).

TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle ,Anlotinib capsules 0 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).

TQB2450 0 mg administered intravenously (IV) on Day 1 of each 21-day cycle ,Anlotinib capsules 0 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).

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.

TQB2450

a multi-target receptor tyrosine kinase inhibitor

Anlotinib

Subjects administrated TQB2450 (blank) intravenously (IV) on Day 1 of each 21-day

TQB2450(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)

Anlotinib(blank)

Ming Chen

Xuhong Min

Li Zhang, Master

Yue Xie, Master

Yuxi Zhu, Doctor

Jiangcheng Li

Ming Chen, Doctor

Yong Bao, Doctor

Suming Pan, Master

Hualin Chen, Doctor

Zhigang Liu, Doctor

Long Chen, master

Long Chen

Jun Wang, Doctor

Anping Zheng, Master

Hong Ge, Doctor

Desheng Hu, Doctor

hui Wang, Doctor

Rongrong Zhou, Doctor

Peiguo Cao, Doctor

Changhua Yu, Master

Jifeng Feng, Doctor

Lianke Liu, Doctor

Junhe Li, Doctor

Yufeng Cheng, Doctor

Yi Geng, Master

Kai Chen, Master

Weihua Yang, Master

Lina Zhao, Doctor

Xiaozhi Zhang, Doctor

Qingsong Pang, Doctor

Sengxiang Yan, Doctor

Ji Yongling, Doctor

Bing Xia, Doctor

Zhibing Wu, Doctor

Xiaodong Liang, Doctor

Hongcheng Wu, Master

Haihua Yang, Master

Shenpeng Ying

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.

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

PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause, based on IRC.

PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause, based on investigator.

OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.

Percentage of participants achieving complete response (CR) and partial response (PR).

Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).

The time when the participants first achieved complete or partial remission to disease progression.

Tissue samples were collected during the screening period for pd-l1 analysis. Blood samples were collected for Tumor Mutation Burden (TMB) test before enrollment (within 7 days before medication) and after exit (±3 days).

Degree of the immune response caused by the drug.

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of TQB2450 in Subjects With Stage III Non-Small Cell Lung Cancer(NSCLC)	NCT04325763	Stage III Non-s...	TQB2450 Anlotinib TQB2450(blank) Anlotinib(blank...	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Study of TQB2450 in Subjects With Stage III Non-Small Cell Lung Cancer(NSCLC)	NCT04325763	Stage III Non-s...	TQB2450 Anlotinib TQB2450(blank) Anlotinib(blank...	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Spots Global Cancer Trial Database for tqb2450(blank)