Apatinib is a new kind of Vascular endothelial growth factor receptor(VEGFR) tyrosine kinase inhibitors (TKIs). The investigators have finished the preclinical and phase I and phase II clinical study for apatinib and found its satisfactory anti-tumor activity and tolerated toxicities. A disease-control rate of 75% was found in lung cancer patients. In the present phase III trial, the investigators will further evaluate the efficacy and toxicities of apatinib in the treatment of advanced non-squamous non-small cell lung cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
480
Cancer Center of Sun Yat-Sen University (CCSU)
Guangzhou, Guangdong, China
Progression free survival (PFS)
Progression-free survival as the time from randomization to documented disease progression according to response evaluation criteria in solid tumors (RECIST) or death.
Time frame: 24 months
Objective Response Rate(ORR)
ORR was the percentage of patients who got partial or complete response
Time frame: 24 months
Overall Survival(OS)
OS was determined from date of enrollment until death or the date the patient was recorded alive of last follow-up
Time frame: 24 months
Toxicity
Adverse events (AEs) were recorded, graded for toxicity using the NCI-CTC, and assessed by the investigator for any relationship with treatment.
Time frame: 24 months
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