Phase II Study of Anlotinib in Patients With Advanced Non-small Cell Lung Cancer（ALTER0302）
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Drug: Placebo capsule
- Registration Number
- NCT01924195
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- 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 andvanced non-small cell lung cancer who failed two lines of chemotherapy
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 117
- pathology diagnosed with advanced NSCL with measurable lesions;
- Have failed for 2 lines of chemotherapy;
- 18-70years,ECOG PS:0-2,Life expectancy of more than 3 months;
- Other cytotoxic drugs,radiation therapy,or surgery≥4 weeks;
- main organs function is normal;
- must be agreed to take contraceptive measures during the study and within 6 months after end.
- SCLC(including mixed with NSCLC);
- the central cavity of Squamous cell carcinoma and hemoptysis with NSCLC;
- patients failed to use the anti-tumor angiogenesis therapy;
- patients has many influence factors toward oral medications ;
- Brain metastases patients accompanied by symptoms or symptom control for less than two months;
- 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.
- patients failed to heal wounds or fractures for Long-term;
- 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;
- patients occurred venous thromboembolic events within 6 months;
- patients has HIV-positive or organ transplantation;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Anlotinib Anlotinib Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent Placebo Capsule Placebo capsule Placebo capsule QD po and it should be continued until disease progression or patients withdrawal of consent
- Primary Outcome Measures
Name Time Method enhanced CT/MRI scan each 42 days up to disease progression To evaluate the effectiveness of Anlotinib Hydrochloric Capsule by enhanced CT/MRI scan every two cycles. Refer to recist 1.1.
- Secondary Outcome Measures
Name Time Method Number of Participants with Adverse Events as a Measure of Safety and Tolerability each 21 days up to intolerance the toxicity(or PD) contain Serious Adverse Event To evaluate the safety of Anlotinib by CTC AE 4.0
Trial Locations
- Locations (13)
Hunan Province Tumor Hospital
🇨🇳Changsha, Hunan, China
Shanghai Changhai Hospital
🇨🇳Shanghai, Shanghai, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
Beijing chest hospital，capital medical university
🇨🇳Beijing, Beijing, China
Xinqiao Hospital, Third Military Medical University
🇨🇳Chongqing, Chongqing, China
The First Affiliated Hospital of Suzhou University
🇨🇳Suzhou, Jiangsu, China
Jilin province tumor hospital
🇨🇳Changchun, Jilin, China
Shandong Province Tumor Hospital
🇨🇳Jinan, Shandong, China
Chest hospital affiliated to Shanghai jiaotong university
🇨🇳Shanghai, Shanghai, China
West China Hospital,Sichuan University
🇨🇳Chengdu, Sichuan, China
Tianjin Medical University Cancer Hospital
🇨🇳Tianjin, Tianjin, China
The first affiliated hospital,zhejiang university
🇨🇳Hangzhou, Zhejiang, China