Anlotinib is a multi-target receptor tyrosine kinase inhibitor under domestic research and
development. It can inhibit angiogenesis-related kinases, 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 systemic chemotherapy (third-line or above) or were intolerant of the
drugs were treated with anlotinib or placebo. The PFS and OS in the anlotinib group were 5.37
months and 9.63 months, respectively. The placebo group PFS and OS were 1.4 months and 6.3
months. Therefore, it is envisaged to use anlotinib combined with docetaxel to treat
wild-type advanced non-squamous non small cell lung cancer to further improve the patient's
PFS or OS.
This is a single arm clinical trial conducted in China. The purpose of this study is to
assess the efficacy and safety of Anlotinib Hydrochloride (12mg, QD PO d1-14, 21days per
cycle) combined with Docetaxel (75mg/m2 IV d1) in the treatment of wild-type advanced
non-squamous non small cell lung cancer patients with progression after immunotherapy plus
chemotherapy as first-line treatment. After being informed about the study and potential
risks, all patients giving written informed consent will undergo a 4-week screening period to
determine eligibility for study entry. The expected sample size is 42.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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