Apatinib Combined With Docetaxel Monotherapy as Second-line Therapy of Advanced EGFR WT, Non-squamous NSCLC

Exclusion Criteria

• •Patients with quamous carcinoma (including adenosquamous carcinoma ); small cell lung cancer (including small cell cancer and non-small cell mixed lung cancer)
• •Patients with active brain metastasis, carcinomatous meningitis, or spinal compression, or disease of brain or pia mater according to the screening test, imaging, CT or MRI tests (patients who have completed the treatment and in a stable condition 21 days before screening could be included, but brain MRI, CT or venography is required to confirm that there are no brain hemorrhage symptoms)
• •Imaging (CT or MRI) results indicate that the distance between the tumor and the large vessel ≤ 5 mm, or the existence of central tumors locally invading the large vessel could be detected
• •Imaging (CT or MRI) indicates apparent pulmonary cavity or necrotizing tumors.
• •Hypertension out of control (systolic pressure≥140 mmHg or diastolic pressure≥90 mmHg, despite optimal drug therapy)
• •Patients with myocardial ischemia or myocardial infarction above grade II, or arrhythmia out of control (including QTc interval ≥450 ms for males and ≥470 ms for females)
• •Patients with cardiac insufficiency grade III\~IV according to NYHA standard, or cardiac color ultrasound indicated LVEF \<50%
• •Abnormal blood coagulation function (INR\>1.5 or prothrombin time (PT)\>ULN+4 seconds, or APTT \>1.5 ULN), with bleeding tendency or ongoing thrombolysis or anti-blood coagulation treatment
• •Patients treated with anticoagulation agents or Vitamin K antagonist such as Warfarin, heparin, or other similar drugs
• •Patients who had obvious hemoptysis within 2 months before screening, or experienced daily hemoptysis with a volume more than half a tea spoon (2.5ml) or above
• •Patients who experienced bleeding symptoms of clinical significance within 3 months before screening, or with confirmed bleeding tendency such as hemorrhage of digestive tract, hemorrhagic gastric ulcer, baseline occult blood in stool ++ and above, or vasculitis, etc
• •Patients who manifested arterial/venous thrombus events, e.g. cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism, etc., within 12 months before screening
• •Known genetic or acquired bleeding or bleeding tendency (such as hemophilia, blood coagulation dysfunction, thrombocytopenia, and hypersplenism, etc.)
• •Patients who have unhealed wounds or fractures for a long time
• •Patients who received major surgical operations or experienced severe traumatic injuries, bone fracture, or ulcers within 4 weeks before screening
• •Patients with obvious factors affecting absorption of oral drugs, such as difficulties in swallowing, chronic diarrhea and intestinal obstruction, etc
• •Occurrence of abdominal fistula, gastrointestinal perforation, or intraperitoneal abscess within 6 months before screening
• •Patients whose routine urine tests indicate that urine protein ≥ ++ or verifies that the 24-h urine protein quantitation ≥ 1.0 g
• •Patients with clinical symptoms, or dropsy of serous cavity requiring surgical treatment (including hydrothorax, ascites, and hydropericardium)
• •Patients who have a history of psychotropic drug abuse and are unable to break the habit, or who have a psychogeny
• •Patients who have taken part in other drug clinical tests within 4 weeks before screening
• •Confirmed ALK genetic abnormality (gene fusion or mutation)
• •Patients who formerly suffered from or currently are complicated with other uncured malignant tumors, except basal cell carcinoma, carcinoma in situ of cervix and superficial bladder cancer that have been cured
• •Patients who received the treatment with potent CYP3A4 inhibitors within 7 days before screening, or potent CYP3A4 inducers within 12 days before being included
• •Pregnant or lactating women, fertile patients who are unwilling or unable to take effective contraceptive measures
• •Conditions determined by investigators to possibly affect the clinical study or determination of the study results