This study is to compare 2-year Disease Free Survival Rate (DFSR) in post radical operation IIIA Non-Small Cell Lung Cancer (NSCLC) patients with Epidermal Growth Factor Receptor (EGFR) 19 or 21 exon mutation treated Erlotinib vs NP chemotherapy as adjuvant therapy.
Name: Erlotinib
Type: DrugArm 1
Name: cis-platinum
Type: DrugArm 2
Name: Vinorelbine
Type: DrugArm 2
Description: 2-year disease free survival rate is defined as the estimation percentage of disease free survival patients with study treatment at 2-year.
Measure: 2-year disease free survival rate (DFSR) Time: 2 yearsDescription: Disease free survival is defined as the time from randomization to disease recurrence or death which comes first.
Measure: disease free survival Time: 5 yearsDescription: Overall survival is defined as the time from randomization to death.
Measure: overall survival (OS) Time: 5 yearsDescription: The score of Functional Assessment of Cancer Therapy - Lung (FACT-L) subscale and Lung Cancer Symptom Scale (LCSS)
Measure: Quality of Life Time: 5 yearsDescription: frequency of Adverse Event
Measure: Adverse Event (AE) Time: 5 yearsDescription: Frequency of Serious Adverse Event (SAE)
Measure: Serious Adverse Event (SAE) Time: 5 yearsAllocation: Randomized
Parallel Assignment
There is one SNP
Inclusion Criteria: - IIIA NSCLC patients according to TMN-staging of Lung Staging Standard version 7 2009, confirmed by histopathology or cytology after radical operation, and having EGFR exon 19 deletion mutation or exon 21 L858R single base substitution; - Accept study adjuvant therapy within 6 weeks post radical operation; - ECOP PS 0-1; Life expectancy ≥12 weeks; - Hematology: absolute neutrophil count (ANC) ≥1.5×10^9/L; platelet count ≥100×10^9/L; hemoglobin concentration ≥ 9.0 g/dL (permit to maintain hematologic criteria by blood transfusion); - Liver Function: TBil ≤1.5xULN; ALT and AST ≤2.5xULN; - Renal Function: Cr ≤1.25xULN, and Ccr ≥60ml/min; - Female patients of childbearing potential must have a negative serum or urine pregnancy test within 7 days before study treatment; - Signed inform consent form by patient or his/her legal representative; - Comply with study protocol and procedure, and be able to take oral medication; Aged ≥18 years and ≦75 years; - Eligible patients of reproductive potential (both sexes) must agree to use a reliable method of birth control before enrollment, during the study period and for at least 30 days after their last dose of study therapy; Exclusion Criteria: - Having treated by Her-Target therapy, i.e. erlotinib, gefitinib, cetuximab, trastuzumab; - Having treated by any systemic anti-tumor therapy of NSCLC, including cytotoxic therapy, target medication treatment (i.e. --- L858R ---