Non-small Cell Lung Cancer Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study of Anlotinib(AL3818) as Third Line Treatment in Patients With Advanced Non-small Cell Lung Cancer(ALTER0302)
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 andvanced non-small cell lung cancer who failed two lines of chemotherapy
Status | Completed |
Enrollment | 117 |
Est. completion date | October 2015 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. pathology diagnosed with advanced NSCL with measurable lesions; 2. Have failed for 2 lines of chemotherapy; 3. 18-70years,ECOG PS:0-2,Life expectancy of more than 3 months; 4. Other cytotoxic drugs,radiation therapy,or surgery=4 weeks; 5. main organs function is normal; 6. must be agreed to take contraceptive measures during the study and within 6 months after end. Exclusion Criteria: 1. SCLC(including mixed with NSCLC); 2. the central cavity of Squamous cell carcinoma and hemoptysis with NSCLC; 3. patients failed to use the anti-tumor angiogenesis therapy; 4. patients has many influence factors toward oral medications ; 5. Brain metastases patients accompanied by symptoms or symptom control for less than two months; 6. patients with severe and failed to controlled diseases,including: suboptimal blood pressure control;suffering from myocardial ischemia or above grade I myocardial infarction, arrhythmias and Class I heart failure;activity or failure to control severe infections;liver disease such as cirrhosis, decompensated liver disease, chronic active hepatitis;poorly controlled diabetes (FBG)>10mmol/L);urine protein=++,etc. 7. patients failed to heal wounds or fractures for Long-term; 8. 4 weeks before enrollment, patients appeared NCI CTC AE grading >1 pulmonary hemorrhage; 4 weeks before enrollment, patients who appeared NCI CTC AE grade> 2 have other parts of the bleeding; patients has a tendency to bleed (eg active peptic ulcer) or are receiving thrombolytic or anticoagulant therapy such as warfarin, heparin or its analogues; 9. patients occurred venous thromboembolic events within 6 months; 10. patients has HIV-positive or organ transplantation; |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Beijing chest hospital,capital medical university | Beijing | Beijing |
China | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing |
China | Jilin province tumor hospital | Changchun | Jilin |
China | Hunan Province Tumor Hospital | Changsha | Hunan |
China | West China Hospital,Sichuan University | Chengdu | Sichuan |
China | Xinqiao Hospital, Third Military Medical University | Chongqing | Chongqing |
China | The first affiliated hospital,zhejiang university | Hangzhou | Zhejiang |
China | Zhejiang Cancer Hospital | Hangzhou | Zhejiang |
China | Shandong Province Tumor Hospital | Jinan | Shandong |
China | Chest hospital affiliated to Shanghai jiaotong university | Shanghai | Shanghai |
China | Shanghai Changhai Hospital | Shanghai | Shanghai |
China | The First Affiliated Hospital of Suzhou University | Suzhou | Jiangsu |
China | Tianjin Medical University Cancer Hospital | Tianjin | Tianjin |
Lead Sponsor | Collaborator |
---|---|
Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | enhanced CT/MRI scan | To evaluate the effectiveness of Anlotinib Hydrochloric Capsule by enhanced CT/MRI scan every two cycles. Refer to recist 1.1. | each 42 days up to disease progression | No |
Secondary | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | contain Serious Adverse Event To evaluate the safety of Anlotinib by CTC AE 4.0 | each 21 days up to intolerance the toxicity(or PD) | Yes |
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