NCT01683175Unknown2 期
A Prospective, Open-labelled, Randomized, Multicenter Phase II Study to Evaluate Efficacy and Safety of Erlotinib vs NP Chemotherapy as Adjuvant Therapy in Post Radical Operation NSCLC Patients With EGFR19 or 21 Exon Mutation
Tianjin Medical University Cancer Institute and Hospital15 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2012年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 94
- 试验地点
- 15
- 主要终点
- 2-year disease free survival rate (DFSR)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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.
研究组 & 干预措施
Arm 1
Experimental
Erlotinib 150mg daily oral up to 2 years
干预措施: Erlotinib (Drug)
Arm 2
Active Comparator
NP Chemotherapy for 4 cycles
干预措施: cis-platinum (Drug)
Arm 2
Active Comparator
NP Chemotherapy for 4 cycles
干预措施: Vinorelbine (Drug)
结局指标
主要结局
2-year disease free survival rate (DFSR)
时间窗: 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.
次要结局
- Quality of Life(5 years)
- Adverse Event (AE)(5 years)
- overall survival (OS)(5 years)
- Serious Adverse Event (SAE)(5 years)
- disease free survival(5 years)
研究者
研究点 (15)
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