NCT03654027

Anlotinib Plus Docetaxel for the Treatment of EGFR/ALK/ROS1 Mutation-negative Advanced Nonsquamous NSCLC

Anlotinib Plus Docetaxel Versus Docetaxel for Treatment of EGFR/ALK/ROS1 Mutation-negative Advanced Nonsquamous NSCLC After Disease Progression on Platinum-based Therapy : a Multicentre, Double-blind, Randomised Explorative Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: First Affiliated Hospital of Guangxi Medical 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 EGFR/ALK/ROS1 mutation-negative advanced nonsquamous 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 is a multicentre randomised controlled clinical trial conducted in China to compare the effectiveness and safety of Anlotinib Plus Docetaxel in patients of EGFR/ALK/ROS1 mutation-negative Advanced nonsquamous Non-squamous Non-small Cell Lung Cancer. Eligible patients will be randomized to arm A and arm B: Arm A: Patients on the anlotinib and docetaxel arm received 75mg/m2 docetaxel as intravenous infusion on day 1 of a 21-day cycle and 12mg anlotinib orally daily on day 1to 14 of a 21-day cycle. Arm B: Patients on the docetaxel arm received 75mg/m2 docetaxel as intravenous infusion on day 1 of a 21-day cycle.

Conditions

• Non-small Cell Lung Cancer

Interventions

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

Timeline

• Start date: 2018-10-01
• Primary completion: 2019-10-01
• Completion: 2020-10-01
• First posted: 2018-08-31
• Last updated: 2018-08-31