Anlotinib Plus Chemotherapy for Patients With Advanced Non-small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT03589950 |
Recruitment Status : Unknown
Verified July 2018 by The First People's Hospital of Lianyungang.
Recruitment status was: Not yet recruiting
First Posted : July 18, 2018
Last Update Posted : July 18, 2018
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Tracking Information | |||||
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First Submitted Date ICMJE | June 22, 2018 | ||||
First Posted Date ICMJE | July 18, 2018 | ||||
Last Update Posted Date | July 18, 2018 | ||||
Estimated Study Start Date ICMJE | August 1, 2018 | ||||
Estimated Primary Completion Date | August 1, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Anlotinib Plus Chemotherapy for Patients With Advanced Non-small Cell Lung Cancer | ||||
Official Title ICMJE | A Parallel Control, Exploratory Trial to Compare Anlotinib Plus Chemotherapy Versus Chemotherapy as Second-line Treatment in Subjects With Advanced Non-small Cell Lung Cancer | ||||
Brief Summary | 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 | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
60 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | August 1, 2021 | ||||
Estimated Primary Completion Date | August 1, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | 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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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03589950 | ||||
Other Study ID Numbers ICMJE | Anlo01 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | The First People's Hospital of Lianyungang | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | The First People's Hospital of Lianyungang | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | The First People's Hospital of Lianyungang | ||||
Verification Date | July 2018 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |