Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Tubulin Modulators

Antimitotic Agents

Anlotinib(12mg QD PO d1-14, 21 days per cycle) plus Docetaxel (75mg/m2 IV d1)

Anlotinib Hydrochloride (12mg QD PO d1-14, 21 days per cycle) and Docetaxel (75mg/m2 IV d1)

Anlotinib Hydrochloride plus Docetaxel

Yu Zhuang, doctor

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 advanced non-small cell lung cancer after the failure of Platinum-Based Doublet-Chemotherapy to further improve the patient's PFS or OS.

This is a multicentre single arm clinical trial conducted in China,the purpose of this study is To Evaluate the Effectiveness and Safety of Anlotinib (12mg QD PO d1-14, 21 days per cycle)Combined with Docetaxel (75mg/m2 IV d1) for advanced non-small cell lung cancer after the failure of Platinum-Based Doublet-Chemotherapy.According to the result of TAX317,the ORR of second line standard chemotherapy was 5- 8%. We expect the ORR was 20%. Using PASS11, we calculated the sample size of this study was 41 , according to 10% censoring,the expected sample size is 46.

Anlotinib Combined With Docetaxel for Advanced Non-Small Cell Lung Cancer（ALTER-L034）

Anlotinib Combined With Docetaxel For Advanced Non-Small Cell Lung Cancer After The Failure Of Platinum-Based Doublet-Chemotherapy

PFS defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.

OS is defined as the time until death due to any cause.

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.

Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.

use EORTC QLQ-C30(version 3) questionnaire to evaluate the quality of life

Spots Global Cancer Trial Database for anlotinib hydrochloride plus docetaxel