A Phase II Trial of Erlotinib Versus Combination of Vinorelbine Plus Cisplatin as Adjuvant Treatment in Stage IIIA Non-small-cell Lung Cancer After Complete Resection With Sensitizing EGFR Mutation in Exon 19 or 21 and Wild-type K-ras
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 80
- 试验地点
- 11
- 主要终点
- Disease-free survival
研究概览
简要总结
The purpose of this study is to assess the effect and safety of erlotinib versus NVB plus cisplatin (NP) as adjuvant treatment in patients with stage IIIA NSCLC after complete resection with EGFR activating mutations and to explore a new treatment strategy for this subset.
详细描述
The LACE meta-analysis identified four cycles of platinum-based program to improve II~IIIA stage completely resected NSCLC pts the role of 5-year survival, but its treatment-related life threatening toxicity limits its use. The EGFR tyrosine kinase inhibitor (TKI) may provide a dramatic response in pts with pulmonary adenocarcinoma carrying EGFR activating mutations in the metastatic setting. The aim of this study is to investigate the efficacy and safety of erlotinib versus NVB plus cisplatin (NP) as adjuvant treatment in pts with stage IIIA NSCLC after Complete Resection with EGFR activating mutations and to explore a new treatment strategy for this subset.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •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. .
排除标准
- •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 ≥
- •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.
研究组 & 干预措施
Erlotinib arm
In the adjuvant treatment phase, erlotinib 150 mg/day taken orally for 2 years or till disease progression or unacceptable toxicity.
干预措施: Erlotinib (Drug)
Chemo arm
In the adjuvant treatment phase, patient will receive vinorelbine 25mg/m2 IV on day 1 and day 8, and cisplatin 25mg/m2 on day 1 and day 2 and day 3, of a 3-week schedule for 4 cycles or till disease progression or unacceptable toxicity.
干预措施: vinorelbine/cisplatin (Drug)
结局指标
主要结局
Disease-free survival
时间窗: 2 years
To evaluate Disease-free survival(DFS) of two groups
次要结局
- Number of Participants with Adverse Events(2 years)
- Quality of Life (QOL)(2 years)
- overall survival (OS)(2 years)