NCT03732001

A Study of Anlotinib in Combination With Docetaxel Versus Docetaxel Alone in Participants With Advanced NSCLC

A Multicenter,Exploratory Study of Anlotinib in Combination With Docetaxel Versus Docetaxel Alone in Participants With Advanced Non-Small Cell Lung Cancer After Failure of First-Line Chemotherapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: China Medical University, China · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the efficacy and safety of Anlotinib in combination with Docetaxel versus Docetaxel in patients with advanced non-small lung cancer after failure of first-line Chemotherapy .

Detailed description

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（12mg，po. qd. on day 1to14 of a 21-day cycle） 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, the investigators envisage using anlotinib plus docetaxel treat the advanced Non-small cell lung cancer patients who were failure of first-line Chemotherapy , to further improve the patient's PFS.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Anlotinib combined Docetaxel	Anlotinib ( 12mg, QD, PO d1-14, 21 days per cycle) and Docetaxel (60mg/m2, IV, d1, 21 days per cycle)
DRUG	Docetaxel	Docetaxel (75mg/m2, IV, d1, 21 days per cycle)

Timeline

• Start date: 2018-11-08
• Primary completion: 2019-11-09
• Completion: 2020-11-09
• First posted: 2018-11-06
• Last updated: 2018-11-28

Locations

1 site across 1 country: China