Study of Anlotinib in Patients With Advanced Non-small Cell Lung Cancer（ALTER0303）
NCT ID: NCT02388919
Last Updated: 2017-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
439 participants
INTERVENTIONAL
2015-02-26
2017-01-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Anlotinib
Anlotinib p.o, qd and it should be continued until disease progress or toxicity cannot be tolerated or patients withdraw consent
Anlotinib
Basic dosage, take once when limosis in the morning. If patients cannot suffer from AEs, they can get declined dosage.
Placebo
Placebo p.o, qd and it should be continued until disease progress or patients withdraw consent
Placebo
Basic dosage, take once when limosis in the morning.
Interventions
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Anlotinib
Basic dosage, take once when limosis in the morning. If patients cannot suffer from AEs, they can get declined dosage.
Placebo
Basic dosage, take once when limosis in the morning.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with advanced NSCLC (phase IIIB/IV) through pathology, with measurable nidus(using RECIST 1.1)
3. at least two systematic chemotherapy with upwards of 3-line treatments or cannot suffer
4. Patients must provide detectable specimen (from tumor tissue or hydrothorax) before participating, who negative in EGFR\&ALK can participate or who positive in EGFR\&ALK, have or have not drug tolerance after the treatment with relative targeted drugs
5. ECOG PS：0-1,Expected Survival Time: Over 3 months
6. main organs function is normal
7. The woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill or condom) during the research and within another 6 months after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; The man patients who must agree to take contraceptive methods during the research and within another 6 months after it
Exclusion Criteria
2. Small Cell Lung Cancer (including small cell cancer and other kinds of cancer mixed with non-small cell cancer)
3. examined as positive in EGFR\&ALK mutation detection and never take the treatment of TKIs
4. central lung squamous carcinoma along with cavum, or non-small cell lung cancer along with hemoptysis (\>50ml/day)
5. other kinds of malignancies within 5 years or for now
6. plan to take systemic anti-tumor therapy within 4 weeks before grouping or during the medicine-taking period of this research, including Cytotoxic Therapy, Signal Transduction Inhibitor, and Immunotherapy (or who use Mitomycin C within 6 weeks before taking the treatment with experimental drug); The patients who have already taken Extended Field Radiotherapy (EF-RT) within 4 weeks before grouping or Limited Field Radiotherapy with proposed assessment of nidus within 2 weeks before grouping
7. have got non remissive toxic reactions derived from previous therapies, which is over level 1 in CTC AE (4.0), alopecia NOT included
8. with kinds of factors which affect oral medicine (e.g. failing to swallow, gastrointestinal tract getting resected, chronic diarrhea and ileus)
9. pleural effusion or ascites, resulting in respiratory syndrome (≥CTC AE level 2)
10. symptoms of brain metastases cannot be controlled and treated within less than 2 months
11. get any severe diseases or the ones that cannot be controlled
12. take major surgical treatments, open biopsy, or get overt traumatic injury within 28 days before grouping
13. have any habitus or medical history of hemorrhage, however severe it is; the patients who have non healing wounds, ulcer or fracture after any events with hemorrhage or bleeding (≥CTCAE level 3)
14. get arterial/venous thrombosis within 6 months, such as cerebrovascular accidents (including temporary ischemic stoke), deevenous thrombosis, and pulmonary embolism
15. ever abuse psychiatric drugs and cannot abstain or who are diagnosed with mental disorder
16. have participated in other clinical trials of anti-tumor medicine within 4 weeks
17. diagnosed with disease which will severely endanger the security of patients or influence the completion of this research.
18 Years
75 Years
ALL
No
Sponsors
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Baohui Han, professor
Role: STUDY_DIRECTOR
Chest hospital affiliated to Shanghai jiaotong university
Kai Lee, professor
Role: STUDY_DIRECTOR
Tianjin Medical University Cancer Hospital
Locations
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Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Capital Medical University, Beijing Chest Hospital
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, 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, 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
Countries
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References
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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.
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.
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.
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.
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.
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.
Related Links
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official website
Other Identifiers
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ALTN-03-IIB
Identifier Type: -
Identifier Source: org_study_id