Phase II Study of Anlotinib in Patients With Advanced Non-small Cell Lung Cancer（ALTER0302）

Study Overview
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Brief Summary
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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

Official Title
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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）

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Anlotinib
* Drug: Placebo capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Anlotinib<br>Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent | Drug: Anlotinib<br>* Anlotinib QD po.<br>|
| Placebo Comparator: Placebo Capsule<br>Placebo capsule QD po and it should be continued until disease progression or patients withdrawal of consent | Drug: Placebo capsule<br>* Placebo QD po.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung, Anlotinib, AL3818, NSCLC, Cancer