NSCLC
Conditions
Interventions
Erlotinib:Erlotinib 150mg daily oral up to 2 years
NP Chemotherapy:NP Chemotherapy
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Inclusion Criteria of Target Disease: 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 4 weeks post radical operation; ECOP PS 0-1; Life expectancy >=12 weeks. Inclusion criteria of Hematology, Biochemistry and Organ functions: Hemotology: absolute neutrophil count (ANC) >=1.5*10^9/L; platelet count >=100*10^9/L; hemoglobin concentration >=9.0 g/dL (permit to maintain hemotologic criteria by blood transfusion); Liver Function: TBil =60ml/min; Female patients of childbearing potential must have a negative serum or urine prenancy test within 7 days before study treatment. General Inclusion Criteria: 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 to 75 years; Eligible patients of reproductive potential (both sexes) must agree to use a reliable method of birth control before enrolment, during the study period and for at least 30 days after their last dose of study therapy.
Exclusion criteria
Exclusion criteria: Exclusion Criteria of Target Disease: 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. monoclonal antibody), investigational therapy; Having local radiotherapy of NSCLC; Upper gastrointestinal physilogical disorders, or melabsorption syndrome, or intolerance of oral medication, or active peptic ulcer; The findings in radical operation are lymph nodes with extracapsular invasion, or fusion, or all of dissection lymph nodes positive by pathology; Diagnosed other malignant tumor besides NSCLC within 5 years prior the study treatment (except having simple surgical resection with 5-year disease free survival,cured in situ of cervical carcinoma, cured basal cell carcinoma and bladder epithelial tumor); Confirmed recurrent cancer by Clinical objective evidence (pathology or radiography images) before the study adjuvant therapy; Exclusion Criteria of Study Drug: Known hypersensitivity to platinum, Vinorelbine, EGFR-TKI agents or relevant components in the formulation; Uncontrolled eye inflammation or infection, or any potential circumstances lead to eye inflammation or infection; Active interstitial lung disease (ILD) by any clinical evidence; patients with any co-morbidities, or motalic disorders, or any abnormal findings in physical examination or laboratory tests are suspected to have contraindication of study therapy or high risk of study treatment complications; General Exclusion Criteria: Any unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, angina starting in latest 3 months, Congestive heart failure (NYHA >=II), myocadial infarction within 6 months prior enrolment, under medication treatment of severe arrythmia, liver, renal or metabolic disease; know HIV infection Pregnant or breastfeeding wemon; ECOG PS >=2; Mixed with small cell lung cancer; Other conditions investigators evaluate that patient is not eligible to this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year disease free survival rate (DFSR); | — |
Secondary
| Measure | Time frame |
|---|---|
| disease free survival;overall survival (OS);safety;Quality of Life;exploramental biomarker; | — |
Countries
China
Contacts
Public ContactChagnli Wang
Outcome results
None listed