Apatinib is a new kind of selective Vascular Endothelial Growth Factor Receptor 2(VEGFR-2) tyrosine kinase inhibitor (TKI). The investigators have finished the preclinical,phase I and phase II clinical studies and found its promising anti-tumor activity and tolerable toxicities. A disease-control rate of 61.1% and a mPFS of 4.7 months were showed in apatinib phase II study in patients with NSCLC. The study aims to compare the efficacy and safety of apatinib to placebo in advanced non-squamous non-small cell lung cancer patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
417
Department of Medical Oncology, Cancer Center, Sun Yet-sen University
Guangzhou, Guangdong, China
RECRUITINGShanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGOverall Survival(OS)
Overall survival (OS) was defined as the time from date of randomization to date of death due to any cause.The date the patient was recorded alive of last follow-up.Median time results from unstratified Kaplan-Meier estimates.
Time frame: 24 months
Progression free survival (PFS)
PFS is defined as time from randomisation to disease progression or death whichever occurs first. Assessed by central independent review according to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
Time frame: 24 months
Objective response rate (ORR)
ORR was defined as the proportion of patients whose best response was Complete Response \[CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target)\] or Partial Response \[PR: at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD\] over the whole duration of study.
Time frame: 24 months
Duration of response (DoR)
DoR was defined as the time from documentation of tumor response to disease progression.
Time frame: 24 months
Disease control rate (DCR)
DCR was defined as the proportion of patients whose best response was CR or PR or Stable Disease (SD)
Time frame: 24 months
Mean Change From Baseline in European Organization for Research and Treatment of Cancer core quality of life questionnaire (EORTC QLQ-C30)
Time frame: 24 months
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