Non-small Cell Lung Cancer
Tianjin Medical University Cancer Institute and Hospital
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.
- Drug: ApatinibTargeted therapy Apatinib：500 mg，po，qd
- Drug: Docetaxelchemotherapy Docetaxel：60mg/m²，vein input 1hour，every 3w
|Ages eligible for Study||18 Years to 75 Years|
|Genders eligible for Study||All|
|Accepts Healthy Volunteers||No|
- ≥ 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.
- 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
- Tianjin Medical University Cancer Institute and HospitalrecruitingTianjin, Tianjin, China, 300060
30 April, 2016
18 May, 2016