NCT03735264

Anlotinib Combined With Docetaxel for Advanced Non-Small Cell Lung Cancer（ALTER-L034）

Anlotinib Combined With Docetaxel For Advanced Non-Small Cell Lung Cancer After The Failure Of Platinum-Based Doublet-Chemotherapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: The Affiliated Hospital of Qingdao University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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,we envisage using anlotinib plus docetaxel treat the advanced non-small cell lung cancer after the failure of Platinum-Based Doublet-Chemotherapy to further improve the patient's PFS or OS.

Detailed 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-small cell lung cancer after the failure of Platinum-Based Doublet-Chemotherapy.According to the result of TAX317,the ORR of second line standard chemotherapy was 5- 8%. We expect the ORR was 20%. Using PASS11, we calculated the sample size of this study was 41 , according to 10% censoring,the expected sample size is 46.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Anlotinib Hydrochloride plus Docetaxel	Anlotinib Hydrochloride (12mg QD PO d1-14, 21 days per cycle) and Docetaxel (75mg/m2 IV d1)

Timeline

• Start date: 2018-11-15
• Primary completion: 2020-10-14
• Completion: 2020-10-15
• First posted: 2018-11-08
• Last updated: 2018-11-08