NCT03726736

Anlotinib Combined With Docetaxel Versus Docetaxel for Previous Treated Advanced NSCLC

Anlotinib Combined With Docetaxel Versus Docetaxel for Platinum-based Therapy Treated Advanced NSCLC: a Multicentre, Randomised Explorative Trial

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 97 (estimated)
• Sponsor: Yong Fang · 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（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,we envisage using anlotinib plus docetaxel treat the EGFR wild-type advanced Non-small cell lung cancer patients who were failure in the treatment of chemotherapy with platinum containing drugs, to further improve the patient's PFS or OS.

Detailed description

This multicentre randomised controlled clinical trial conducted in China include phase I study and phase II study. Phase I study: to get the maximum tolerated dose of anlotinib when combined with Docetaxel. Phase II study: to compare the effectiveness and safety of Anlotinib Plus Docetaxel in patients of EGFR wild-type Advanced Non-squamous Non-small Cell Lung Cancer.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Anlotinib combined Docetaxel	Anlotinib ( dose base on phase I study, QD PO d1-14, 21 days per cycle) and Docetaxel (60mg/m2 IV, d1, 21 days per cycle)
DRUG	Docetaxel	Docetaxel (60mg/m2 IV, d1, 21 days per cycle)

Timeline

• Start date: 2018-12-21
• Primary completion: 2019-11-01
• Completion: 2020-11-01
• First posted: 2018-10-31
• Last updated: 2019-06-07

Locations

1 site across 1 country: China