Apatinib Plus Docetaxel as 2nd Line Treatment in Patients With Advanced Non-squamous and Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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The purpose of this Phase II, Open-label, single arm, exploratory study is to evaluate the efficacy and the safety of Apatinib（500mg/d）with docetaxel (60 mg/m²) in advanced Non-squamous Non-small cell lung cancer after failure of first line chemotherapy.

Official Title
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Apatinib Plus Docetaxel as 2nd Line Treatment in Patients With Advanced Non-squamous and Non-small Cell Lung Cancer

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Apatinib
* Drug: Docetaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 and ≤ 75 years of age Histologically or cytologic confirmed advanced non-squamous and non-small cell lung cancer. EGFR mutation testing negative of sensitive mutations At least one measurable lesion which has not received radiotherapy (larger than 10 mm in diameter by spiral CT scan) Have failed for 1 lines of chemotherapy ECOG performance scale 0 - 1. Life expectancy of more than 3 months. Duration from the last therapy is more than 6 weeks for nitroso or mitomycin More than 4 weeks after operation or radiotherapy More than 4 weeks for cytotoxic agents Adequate hepatic, renal, heart, and hematologic functions (hemoglobin ≥ 90g/L, platelets ≥ 80×10^9/L, neutrophils ≥ 1.5×10^9/L, total bilirubin within 1.25×the upper limit of normal(ULN), and serum transaminase≤2.5×the ULN (If liver metastases, serum transaminase≤5×the ULN), serum creatine ≤ 1.5 x ULN, creatinine clearance rate ≥ 50ml/min, Signed and dated informed consent.Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure. Exclusion Criteria: Received more than one kind of chemotherapy regimens NSCLC received other VEGFR inhibitors (except beacizumab) or docetaxel chemotherapy Existing therapy related toxicity of prior chemotherapy and/or radiation therapy Intercurrence with one of the following: hypertension, coronary artery disease, arrhythmia and heart failure Any factors that influence the usage of oral administration The center of the tumor invaded local large blood vessels Within 4 weeks before the first use of drugs, occurs pulmonary hemorrhage (≥ CTCAE class 2) or other parts' hemorrhage (≥ CTCAE class 3). Within 6 months before the first treatment occurs artery / venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism, etc. Less than 4 weeks from the last clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Apatinib：500 mg，po，qd； Docetaxel：60mg/m²，vein input 1hour，every 3w | Drug: Apatinib<br>* Targeted therapy Apatinib：500 mg，po，qd<br>* Other names: YN968D1;Drug: Docetaxel<br>* chemotherapy Docetaxel：60mg/m²，vein input 1hour，every 3w<br>* Other names: Taxotere;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival |  | 1 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective remission rate |  | 1 Day | 
| disease control rate |  | 1 Day | 
| Quality of life score |  | 1 Day |