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Evaluate the efficacy and safety of Anlotinib as the 3-line treatment of patients with advanced non-small lung cancer, with placebo control.
Anlotinib (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 VEGFR1、VEGFR2、VEGFR3、FGFR1/2/3、PDGFRa/β c-Kit and MET.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anlotinib | Experimental | Anlotinib p.o, qd and it should be continued until disease progress or toxicity cannot be tolerated or patients withdraw consent |
|
| Placebo | Placebo Comparator | Placebo p.o, qd and it should be continued until disease progress or patients withdraw consent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anlotinib | Drug | Basic dosage, take once when limosis in the morning. If patients cannot suffer from AEs, they can get declined dosage. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | From randomization until death (up to 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Progress free survival (PFS) | each 42 days up to PD or death(up to 24 months) | |
| Objective Response Rate (ORR) | each 42 days up to intolerance the toxicity or PD (up to 24 months) | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Baohui Han, professor | Chest hospital affiliated to Shanghai jiaotong university | Study Director |
| Kai Lee, professor | Tianjin Medical University Cancer Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital, Capital Medical University | Beijing | Beijing Municipality | China | |||
| Capital Medical University, Beijing Chest Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32944404 | Derived | Qin T, Liu Z, Wang J, Xia J, Liu S, Jia Y, Liu H, Li K. Anlotinib suppresses lymphangiogenesis and lymphatic metastasis in lung adenocarcinoma through a process potentially involving VEGFR-3 signaling. Cancer Biol Med. 2020 Aug 15;17(3):753-767. doi: 10.20892/j.issn.2095-3941.2020.0024. | |
| 32077550 | Derived | Jiang S, Liang H, Liu Z, Zhao S, Liu J, Xie Z, Wang W, Zhang Y, Han B, He J, Liang W. The Impact of Anlotinib on Brain Metastases of Non-Small Cell Lung Cancer: Post Hoc Analysis of a Phase III Randomized Control Trial (ALTER0303). Oncologist. 2020 May;25(5):e870-e874. doi: 10.1634/theoncologist.2019-0838. Epub 2020 Feb 20. |
| Label | URL |
|---|---|
| official website | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 7, 2018 | |
| Reset | Sep 14, 2018 |
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| Placebo | Drug | Basic dosage, take once when limosis in the morning. |
|
| Disease Control Rate (DCR) |
| each 42 days up to intolerance the toxicity or PD (up to 24 months) |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Until 30 day safety follow-up visit |
| Beijing |
| Beijing Municipality |
| China |
| Chinese Academy of Medical Sciences Cancer Hospital | Beijing | Beijing Municipality | China |
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | China |
| Chongqing Cancer Hospital | Chongqing | Chongqing Municipality | China |
| Xinqiao Hospital | Chongqing | Chongqing Municipality | China |
| Fujian Province Tumor Hospital | Fuzhou | Fujian | China |
| Gansu Province Tumor Hospital | Lanzhou | Gansu | China |
| Gansu Provincial People 's Hospital | Lanzhou | Gansu | China |
| Lanzhou Military General Hospital | Lanzhou | Gansu | China |
| First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | China |
| First Affiliated Hospital of Shantou University Medical College | Shantou | Guangdong | China |
| Fourth Hospital of Hebei Medical University | Shijiazhuang | Hebei | China |
| Harbin medical university affiliated tumor hospita | Harbin | Heilongjiang | China |
| Henan Province Tumor Hospital | Luoyan | Henan | China |
| Hunan Province Tumor Hospital | Changsha | Hunan | China |
| Xiangya Hospital Central South University | Changsha | Hunan | China |
| Lianyungang First People 's Hospital | Lianyungang | Jiangsu | China |
| Xuzhou Medical College Hospital | Xuzhou | Jiangsu | China |
| Jiangxi Province Tumor Hospital | Nanchang | Jiangxi | China |
| Second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | China |
| Jilin Province Tumor Hospital | Changchun | Jilin | China |
| Liaoning Provincial Tumor Hospital | Shenyang | Liaoning | China |
| Qilu Hospital,Shandong University | Jinan | Shandong | China |
| Shandong Province Tumor Hospital | Jinan | Shandong | China |
| Linyi City Tumor Hospita | Linyi | Shandong | China |
| Chest hospital affiliated to Shanghai jiaotong university | Shanghai | Shanghai Municipality | 200000 | China |
| Cancer Hospital of Fudan University | Shanghai | Shanghai Municipality | China |
| Shanghai Changhai Hospital | Shanghai | Shanghai Municipality | China |
| Xinhua hospital affiliated to Shanghai jiaotong university | Shanghai | Shanghai Municipality | China |
| First Affiliated Hospital of Xi'an Jiaotong University | Xian | Shanxi | China |
| Tang Du Hospital | Xian | Shanxi | China |
| West China Hospital , Sichuan University | Chengdu | Sichuan | China |
| Sichuan Cancer Hospital | Chongqing | Sichuan | China |
| 20th Floor, Block C, Lake Road, Hexi District, Tianjin Medical University Cancer Institute and Hospital . | Tianjin | Tianjin Municipality | 300600 | China |
| Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | China |
| Yunnan Province Tumor Hospital | Kunming | Yunnan | China |
| The First Affiliated Hospital of Zhejiang University | Hangzhou | Zhejiang | China |
| The Second Affiliated Hospital of Zhejiang University | Hangzhou | Zhejiang | China |
| Zhejiang Province Tumor Hospital | Hangzhou | Zhejiang | China |
| 31689797 | Derived | Zhang PL, Liu ZJ. Esophago-tracheobronchial fistula following treatment of anlotinib in advanced squamous cell lung cancer: Two case reports. Medicine (Baltimore). 2019 Nov;98(44):e17700. doi: 10.1097/MD.0000000000017700. |
| 30392239 | Derived | Si XY, Wang HP, Zhang XT, Wang MZ, Zhang L. [Efficacy and safety of anlotinib in 16 patients with advanced non-small cell lung cancer]. Zhonghua Nei Ke Za Zhi. 2018 Nov 1;57(11):830-834. doi: 10.3760/cma.j.issn.0578-1426.2018.11.007. Chinese. |
| 30098152 | Derived | Han B, Li K, Wang Q, Zhang L, Shi J, Wang Z, Cheng Y, He J, Shi Y, Zhao Y, Yu H, Zhao Y, Chen W, Luo Y, Wu L, Wang X, Pirker R, Nan K, Jin F, Dong J, Li B, Sun Y. Effect of Anlotinib as a Third-Line or Further Treatment on Overall Survival of Patients With Advanced Non-Small Cell Lung Cancer: The ALTER 0303 Phase 3 Randomized Clinical Trial. JAMA Oncol. 2018 Nov 1;4(11):1569-1575. doi: 10.1001/jamaoncol.2018.3039. |
| 30032842 | Derived | Si X, Zhang L, Wang H, Zhang X, Wang M, Han B, Li K, Wang Q, Shi J, Wang Z, Cheng Y, He J, Shi Y, Chen W, Wang X, Luo Y, Nan K, Jin F, Li B, Chen Y, Zhou J, Wang D. Quality of life results from a randomized, double-blinded, placebo-controlled, multi-center phase III trial of anlotinib in patients with advanced non-small cell lung cancer. Lung Cancer. 2018 Aug;122:32-37. doi: 10.1016/j.lungcan.2018.05.013. Epub 2018 May 18. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 7, 2018 | Sep 14, 2018 |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000625192 | anlotinib |
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