Non-small Cell Lung Cancer Clinical Trial
Official title:
Anlotinib Combined With Docetaxel Versus Docetaxel for Platinum-based Therapy Treated Advanced NSCLC: a Multicentre, 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（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.
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.
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