Non-small Cell Lung Cancer
Conditions
Keywords
lung, Anlotinib, AL3818, NSCLC, 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 andvanced non-small cell lung cancer who failed two lines of chemotherapy
Interventions
DRUGAnlotinib
Anlotinib QD po.
DRUGPlacebo capsule
Placebo QD po.
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Outcome results
None listed