Anlotinib is a multi-target receptor tyrosine kinase inhibitor in 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 EGFR mutations advanced non small cell lung cancer to further improve the patient's PFS or OS.
Name: Anlotinib Hydrochloride plus Docetaxel
Description: PFS is defined as the time from the date of enrollment to the first occurrence of disease progression or death due to any cause.
Measure: Progress free survival (PFS) Time: each 42 days up to PD or death (up to 24 months)Description: OS is defined as the time from the date of enrollment to the date of death due to any cause.
Measure: Overall Survival (OS) Time: From randomization until death (up to 24 months)Description: ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.prior to progression or any further therapy.
Measure: Objective Response Rate (ORR) Time: each 42 days up to intolerance the toxicity or PD (up to 24 months)Description: DCR is defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.
Measure: Disease Control Rate (DCR) Time: each 42 days up to intolerance the toxicity or PD (up to 24 months)Description: use EORTC QLQ-C30(version 3) questionnaire to evaluate the quality of life.
Measure: Quality of Life score (QoL) Time: each 42 days up to intolerance the toxicity or PD (up to 24 months)Allocation: N/A
Single Group Assignment
There is one SNP
- Patients who were resistant to EGFR targeted treatment need to receive T790M mutation test. --- T790M ---