Non-small Cell Lung Cancer Clinical Trial
Official title:
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
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.
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.
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