Erlotinib Versus Vinorelbine/Cisplatin as Adjuvant Treatment in Stage IIIA NSCLC Patients With EGFR Mutations

This is an interventional treatment trial for Non-small Cell Lung Cancer Stage IIIA focused on measuring NSCLC, EGFR Mutation Positive, complete resection, Erlotinib Versus NVB/Cisplatin as Adjuvant treatment Read More

Inclusion Criteria:

• Written informed consent provided.
• Males or females aged ≥18 years.
• Chest CT, brain CT or MRI, ECT, abdominal and double-neck B-, or whole body PET-CT examination in 4 weeks before complete resection.
• Pathological diagnosed of non-small cell lung cancer.
• Diagnosed as stage IIIA.
• In 4 weeks after complete resection pts start to accept the adjuvant therapy in this study, previously did not receive any anti-tumor therapy.
• EGFR activating mutation in exon 19 or 21 and KARS
• ECOG performance status 0-1.
• Life expectancy ≥3 months.
• Adequate hematological function:Absolute neutrophil count (ANC) ≥1.5 x 109/L, and Platelet count ≥100 x 109/L, and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level).
• Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN);Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN.
• Adequate renal function:Serum creatinine ≤ 1.25 x ULN, and creatinine clearance ≥ 60 ml/min.
• Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
• Patients must be nonpregnant and non-lactating.Patients of childbearing potential must implement an effective method of contraception during the study. All female Patients, except those who are postmenopausal or surgically sterilized, must have a negative pre-study serum or urine pregnancy test. .

Exclusion Criteria:

• Patients with prior exposure to agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
• Patients with prior chemotherapy or therapy with systemic anti-tumour therapy.
• Patients with prior radiotherapy.
• History of another malignancy in the last 5 years with the exception of the following:Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted.
• Any evidence confirmed tumor recurrence before adjuvant treatment.
• Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
• Any evidence of clinically active interstitial lung disease.
• Eye inflammation or eye infection not fully treated or conditions predisposing the subject to this.
• Known human immunodeficiency virus (HIV) infection.
• Known hypersensitivity to Tarceva or NVB or cisplatin.
• Pregnancy or breast-feeding women.
• ECOG performance status ≥ 2.
• Ingredients mixed with small cell lung cancer patients
• Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicated the use of an investigational drug or puts the subject at high risk for treatment-related complications.