Patients with advanced non-small cell lung cancer (NSCLC) who progress slowly after Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors(EGFR-TKI)resistance. The purpose of this study is to investigate the efficacy and drug resistance mechanism of Apatinib combine with EGFR-TK1 treated for advanced slow progressed non-small cell lung cancer and provide new treatment options.
Epidermal growth factor receptor Tyrosine kinase inhibitor (EGFR TKI) have been approved to treat NSCLC harboring EGFR mutation as first-line therapy. However, a large proportion of patients would become acquired resistant of EGFR-TKI after about one year although initially sensitivity. Previous studies demonstrated that the anti-angiogenesis combined with EGFR-TKI in slow-progressed EGFR mutation-positive non-small cell lung cancer achieved good efficacy and disease control rates, prolonged the progression free survival. The present study is aim to expand the number of samples to monitor resistance-related genes and tumor cells. Furthermore, to investigate the mechanism of anti-angiogenesis combine with EGFR-TKI and provide the theory for the use and promotion of clinically protocols. In this study, the primary objective is the objective response rates and the secondary goal are disease control rates, overall survival, progression free survival and drug safety.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Patients with advanced non-small cell lung cancer (NSCLC) who had treated with EGFR-TKI and progressed slowly because of resistance are underwent with apatinib mesylate and continuous EGFR-TKI.
The Beijing Chest Hospital
Beijing, China
RECRUITINGObjective response rates (ORR)
Objective response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response according to Response Evaluation Criteria in Solid Tumors 1.1(RECIST1.1)
Time frame: two years
Disease control rate (DCR)
Disease Control Rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease according to radiological assessments.
Time frame: two years
Overall survival (OS)
Time from randomization to death for any cause.
Time frame: two years
Progression free survival (PFS)
PFS defined as date of randomization until the date of objectively determined progression defined by Response Evaluation Criteria in Solid Tumors criteria or death from any cause, whichever is first.
Time frame: two years
Drug safety: Number of participants with treatment-related adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: two years
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