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| Name | Class |
|---|---|
| Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | INDUSTRY |
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Anlotibib (AL3818) is a kind of innovative medicines approved by State Food and Drug Administration(SFDA:2011L00661) which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2、VEGFR3、PDGFRβ and c-Kit. It has the obvious resistance to new angiogenesis. The trial is to explore Anlotinib for the effectiveness and safety of advanced non-small cell lung cancer who failed first lines of chemotherapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anlotinib plus chemotherapy | Experimental | Anlotinib (12mg QD PO d1-14, 21 days per cycle) + Docetaxel (75mg/m2 IV d1)/Pemetrexed (500 mg/m2 IV d1), q21d/S-1 (80-120mg/day,depending on body surface area; days 1-28 in a 6-week cycle) |
|
| Chemotherapy | Active Comparator | Docetaxel (75mg/m2 IV d1)/Pemetrexed (500 mg/m2 IV d1), q21d/S-1 (80-120mg/day,depending on body surface area; days 1-28 in a 6-week cycle) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anlotinib plus chemotherapy | Drug | Anlotinib (12mg QD PO d1-14, 21 days per cycle), Docetaxel (75mg/m2 IV d1)/Pemetrexed (500 mg/m2 IV d1), q21d/S-1 (80-120mg/day,depending on body surface area; days 1-28 in a 6-week cycle) |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | progression-free survival | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months |
| DCR | Disease Control Rate | Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| OS | Overall survival | From randomization until death (up to 24 months) |
| ORR | Objective Response Rate | each 21 days up to the toxicity or PD (up to 24 months) |
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Inclusion Criteria:
Exclusion Criteria:
1. Small Cell Lung Cancer; 2. Subjects with symptomatic brain metastases; 3. Survival expectation < 3 months; 4. examined as positive in EGFR&ALK mutation detection and never take the treatment of TKIs 5. Blood transfusion is required in the first dose of drug treatment within 14 days ; 6. The interval of subjects had received chemotherapy, biotherapy, radiotherapy or other anticancer therapies in the first dose of drug treatment within 21 days(excluding palliative radiotherapy); 7. The risk of active bleeding; 8. Subjects with uncontrolled blood pressure with medication (140/90 mmHg) 9. Laboratory values and organ functions : (1)Hematologic insufficiency:
10. impairment of heart function: (1)Left ventricular ejection fraction (LVEF) <45% (LVEF evaluation is not required for subjects have no history of congestive heart failure), (2)Unstable angina, (3)Severe arrhythmia, (4)NYHA III or IVgrade of congestive heart failure, (5) Subjects with myocardial infarction within the last 12 months before entering the trial, (6)Pericardial effusion, 11. Subjects with liver fibrosis or hepatic cirrhosis 12. (1)Subjects with other active malignancy (except for definitively treated non melanoma skin cancer,carcinoma in-situ of the cervix,or other cancers that are treated with curative treatment and have no signs of recurrence for at least 5 years ) , (2)Subjects with dysphagia,malabsorption,chronic gastrointestinal diseases,or other medical history may hinder compliance and / or experimental drug absorption, 13. Subjects with major surgery in the first dose of drug treatment within 28 days, 14. Subjects with positive unknown human immunodeficiency virus.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xiaodong jiang, MD | Contact | 18961326201 | jxdysy1970@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Lianyungang Hospital of Xuzhou Medical University | Lianyungang | Jiangsu | 222002 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29446853 | Background | Xie C, Wan X, Quan H, Zheng M, Fu L, Li Y, Lou L. Preclinical characterization of anlotinib, a highly potent and selective vascular endothelial growth factor receptor-2 inhibitor. Cancer Sci. 2018 Apr;109(4):1207-1219. doi: 10.1111/cas.13536. Epub 2018 Mar 25. | |
| 27716285 | Background | Sun Y, Niu W, Du F, Du C, Li S, Wang J, Li L, Wang F, Hao Y, Li C, Chi Y. Safety, pharmacokinetics, and antitumor properties of anlotinib, an oral multi-target tyrosine kinase inhibitor, in patients with advanced refractory solid tumors. J Hematol Oncol. 2016 Oct 4;9(1):105. doi: 10.1186/s13045-016-0332-8. |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000625192 | anlotinib |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| chemotherapy | Drug | Docetaxel (75mg/m2 IV d1)/Pemetrexed (500 mg/m2 IV d1), q21d/S-1 (80-120mg/day,depending on body surface area; days 1-28 in a 6-week cycle) |
|
| Quality of life score | Quality of life score | each 21 days up to the toxicity or PD (up to 24 months) |
| Safety | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | each 21 days up to the toxicity or PD (up to 24 months) |
| 29438373 | Background | Han B, Li K, Zhao Y, Li B, Cheng Y, Zhou J, Lu Y, Shi Y, Wang Z, Jiang L, Luo Y, Zhang Y, Huang C, Li Q, Wu G. Anlotinib as a third-line therapy in patients with refractory advanced non-small-cell lung cancer: a multicentre, randomised phase II trial (ALTER0302). Br J Cancer. 2018 Mar 6;118(5):654-661. doi: 10.1038/bjc.2017.478. Epub 2018 Feb 13. |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |