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Anlotinib Combined With Docetaxel for Advanced Non-squamous Non-Small Cell Lung Cancer — ACDFNSNSCLC  

Non Small Cell Lung Cancer Clinical Trial

Official title:
Anlotinib Combined With Docetaxel as Second-line Treatment of Patients With Wild-type Advanced Non-squamous NSCLC

Clinical Trial Summary

Anlotinib is a multi-target receptor tyrosine kinase inhibitor in domestic research and development. It can inhibit the angiogenesis related kinase, such as VEGFR, FGFR, PDGFR, and tumor cell proliferation related kinase -c-Kit kinase. In the phase Ⅲ study, patients who failed at least two kinds of systemic chemotherapy (third line or beyond) or drug intolerance were treated with anlotinib or placebo, the anlotinib group PFS and OS were 5.37 months and 9.63 months, the placebo group PFS and OS were 1.4 months and 6.3 months. Therefore,envisage using anlotinib plus docetaxel treat the advanced Non-squamous non-small cell lung cancer to further improve the patient's PFS or OS.

Clinical Trial Description

This is a multicentre single arm clinical trial conducted in China,the purpose of this study is To Evaluate the Effectiveness and Safety of Anlotinib (12mg QD PO d1-14, 21 days per cycle)Combined with Docetaxel (75mg/m2 IV d1) for advanced Non-squamous non-small cell lung cancer.According to the result of TAX317,the PFS of second line standard chemotherapy was 3 month. Expected the PFS was 5.7. Using PASS11, That calculated the sample size of this study was 41 , according to 10% censoring,the expected sample size is 46. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03750916
Study type Interventional
Source Qilu Hospital of Shandong University
Contact Wang Xiuwen, doctor
Phone 008618560082906
Email wangxiuwen@medmail.com.cn
Status Not yet recruiting
Phase Phase 2
Start date November 30, 2018
Completion date November 30, 2020
View Details
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