Apatinib in the Treatment of Advanced Non-squamous Non-small Cell Lung Cancer:a Randomised, Double-blind, Placebo-controlled, Multicentre Phase III Study
Inclusion Criteria:
1. Patients 18 to 70 years of age
2. Documented pathological evidence of advanced non-squamous non-small cell lung cancer
with measurable lesions
3. Failure of epidermal-growth-factor receptor (EGFR) TKIs target treatment and
second-line or more regimens of chemotherapy
4. Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 1
5. Patients had to have recovered from any toxic effects of therapy
6. Patients with brain/meninges metastasis should keep stable disease for 2 months
before randomisation
7. Adequate hematologic and biochemical values were required
Exclusion Criteria:
1. Presence of small-cell lung cancer alone or with NSCLC
2. Pregnant or breast-feeding women
3. Severe or uncontrolled systemic disease such as clinically significant
hypertension(systolic pressure > 140 mmHg,diastolic pressure > 90 mmHg), cardiac
ischemia and infarction, ventricular arrhythmias(QT ≥ 440ms) and grade 1 cardiac
insufficiency
4. Difficulties in taking pills (inability to swallow tablets,GI tract resection,
chronic bacillary diarrhea and intestinal obstruction)
5. Coagulation disfunction,hemorrhagic tendency or receiving anticoagulant therapy
6. ≥ CTCAE 2 pneumorrhagia or ≥ CTCAE 3 hemorrhage in other organs within 4 weeks
7. Bone fracture or wounds that was not cured for a long time
8. Arterial thrombus or phlebothrombosis within 6 months and taking anticoagulant agents
9. Mental diseases and psychotropic substances abuse
10. Previous treatment with an experimental agent within 4 weeks
11. Previous treatment with VEGFR、platelet derived growth factor receptor(PDGFR) TKIS
12. Other coexisting malignant disease (apart from basal-cell carcinoma and carcinoma in
situ of uterine cervix)