Erlotinib in Post Radical Operation NSCLC Patients With EGFR Mutation
- Conditions
- Non-small Cell Lung Cancer Stage III
- Interventions
- Registration Number
- NCT01683175
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 94
- 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;
- 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 physiological disorders, or malabsorption 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;
- 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;
- Any unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, angina starting in latest 3 months, Congestive heart failure (NYHA ≥ II), myocardial infarction within 6 months prior enrollment, under medication treatment of severe arrhythmia, liver, renal or metabolic disease;
- know HIV infection Pregnant or breastfeeding women;
- ECOG PS ≥2;
- Mixed with small cell lung cancer;
- Other conditions investigators evaluate that patient is not eligible to this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2 cis-platinum NP Chemotherapy for 4 cycles Arm 1 Erlotinib Erlotinib 150mg daily oral up to 2 years Arm 2 Vinorelbine NP Chemotherapy for 4 cycles
- Primary Outcome Measures
Name Time Method 2-year disease free survival rate (DFSR) 2 years 2-year disease free survival rate is defined as the estimation percentage of disease free survival patients with study treatment at 2-year.
- Secondary Outcome Measures
Name Time Method overall survival (OS) 5 years Overall survival is defined as the time from randomization to death.
Quality of Life 5 years The score of Functional Assessment of Cancer Therapy - Lung (FACT-L) subscale and Lung Cancer Symptom Scale (LCSS)
Adverse Event (AE) 5 years frequency of Adverse Event
Serious Adverse Event (SAE) 5 years Frequency of Serious Adverse Event (SAE)
disease free survival 5 years Disease free survival is defined as the time from randomization to disease recurrence or death which comes first.
Trial Locations
- Locations (15)
The affiliated hospital of medical college Qingdao University
🇨🇳Qingdao, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, China
The third affiliated hospital of Harbin Medical Univer
🇨🇳Harbin, China
Hebei Provincial Tumor Hospital
🇨🇳Shijiazhuang, China
The second people's hospital of Sichuan
🇨🇳Chengdu, China
Beijing Cancer Hospital
🇨🇳Beijing, China
Sun Yat-Sen University Cancer Center
🇨🇳Guangzhou, China
Chinese PLA General Hospital
🇨🇳Beijing, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, China
Zhongshan Hospital Fudan University
🇨🇳Shanghai, China
The first affiliated hospital of Soochow University
🇨🇳Suzhou, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, China
Tianjin Medical University Cancer Institute and Hospital
🇨🇳Tianjin, Tianjin, China
Liaoning Cancer Hospital & Institute
🇨🇳Shenyang, China
The fourth military medical university，Tangdu Hospital
🇨🇳Xi'an, China