This study will be performed as a local multicenter, randomized, phase III clinical study. It will compare the adjuvant chemotherapy in Stage IB-IIIA NSCLC with common EGFR mutation (Exon 19 deletion or L858R) who underwent total resection and the Erlotinib-Intercalation adjuvant chemotherapy with the chemotherapy alone. The patients will be randomly assigned to the Intercalation combination chemotherapy regimen and the chemotherapy alone regimen at the ratio of 1:1. The treatment regimen of each arm is as follows.
Name: intercalation therapy using pemetrexed, cisplatin and erlotinib
Name: Vinorelbine, cisplatin
Description: Time from randomization to disease recurrence or death of any causeMeasure: Disease-free survival (DFS) Time: 3 years
There are 2 SNPs
It will compare the adjuvant chemotherapy in Stage IB-IIIA NSCLC with common EGFR mutation (Exon 19 deletion or L858R) who underwent total resection and the Erlotinib-Intercalation adjuvant chemotherapy with the chemotherapy alone. --- L858R ---
- Stage IB-IIIA Non-squamous NSCLC (Based on AJCC Version 7 TNM Disease Stages) - Surgically complete resection - Confirmed with Exon 19 deletion or L858R EGFR mutation - Complete recovery from the surgery. --- L858R ---
- Age to be ≥ 19 years old - Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Patients who are not pregnant or breastfeeding - Appropriate functions of bone marrow, liver and kidney, when assessed with the following requirements of the laboratory tests to be conducted within 14 days before the initial dose of the study drug: - Absolute neutrophil count (ANC) ≥ 1.5 x 109/L - Platelet count ≥ 100 x 109/L - Total bilirubin ≤ 1.5 times greater than the upper limit of normal - ALT and AST ≤ 2.5 times greater than the upper limit of normal - Alkaline phosphatase ≤ 2.5 times greater than the upper limit of normal - INR and PTT ≤ 1.5 times greater than the upper limit of normal - Appropriate renal function: Serum creatinine ≤ 1.25 × upper limit of normal, or serum creatinine clearance according to Cockcroft-Gault formula(below) ≥50 mL/min Woman CrCl = (140- age [years old]) x weight (kg) x 0.85 72 x serum creatinine (mg/dL) Man CrCl = (140- age [years old]) x weight (kg) x 1.00 72 x serum creatinine (mg/dL) - Patients who are capable of complying with the clinical study protocol and who can take medication orally - Patient who can hear sufficient explanation and sign on the informed consent form Exclusion Criteria: - Any subject who shows any of the following criteria should be excluded from this clinical study: - Patient identified with T790M mutation - Treatable with topical treatments (radiotherapy or surgery) - Previous treatment to inhibit the human epidermal growth factor receptor (EGFR) (e.g. --- T790M ---