NCT01951469Unknown3 期
Multicenter Phase III Study of Gefitinib Mono-therapy or Gefitinib Combined With Chemotherapy in Patients With Brain Metastases From Non-small Cell Lung Cancer Harboring EGFR Mutation
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2016年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- iPFS(intracranial progression free survival
研究概览
简要总结
This is a multi-center phase III randomized controlled study to assess the efficacy of Gefitinib alone and Gefitinib combination with Pemetrexed/platinum on patients with brain metastasis from non-small cell lung cancer(NSCLC) harboring EGFR mutation type by intracranial PFS(iPFS),also PFS ,DCR and OS.The side effect is evaluated as well.
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
- •Patient who was confirmed stage IV NSCLC with EGFR activating mutation and brain metastases by pathologic histology or cytology
- •Patients who had never received therapy (including chemotherapy,WBRT,EGFR-TKI and EGFR monoclonal antibody) after diagnosed brain metastases
- •Patients had at least three metastatic lesions in brain, or patients with 1-2 intracranial lesions who were not suitable for brain radiotherapy, or patients with 1-2 intracranial lesions who refused brain radiotherapy, at least one intracranial lesion with the longest diameter of >5 mm
- •Adult patients (≥ 18 years and ≤75 years). ECOG Performance Status 0 or 1 Life expectancy of at least 12 weeks.,Haemoglobin ³ 10.0 g/dl, Absolute neutrophil count (ANC) ³1.5 x 109/L, platelets ³ 100 x 109/L. Total bilirubin £ 1.5 x upper limit of normal (ULN). ALT and AST < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases. Creatinine clearance ³ 60ml/min (calculated according to Cockcroft-gault formula).
- •Patients should be contraceptive during the period of the trial until 8 weeks after the last administration of icotinib.
- •Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
排除标准
- •Patient was received irradiation of brain. Patient with meningeal metastases were confirmed by MRI or cytology test of cerebrospinal fluid.
- •Patient is received the treatment of Phenytoin, carbamazepine, rifampicin, phenobarbital, or St. John's Wort.
- •Patient was received EGFR Tyrosine Kinase Inhibitor or EGFR monoclonal antibody.
- •Interstitial pneumonia.Pericardial effusion, pleural effusion is uncontrolled .
- •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 significant ophthalmologic abnormality ,especially severe dry eye syndrome ,keratoconjunctivitis sicca,Sjogren syndrome,severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions.
- •Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease.
- •The symptoms of increased intracranial pressure are uncontrolled after dehydration and cortisone treatment
研究组 & 干预措施
Gefitinib and Pemetrexed/platinum
Experimental
Gefitinib 250mg is Taken Orally on day 1-28,combined Pemetrexed (D1)+cisplatin (D1-3) chemotherapy or Pemetrexed (D1)+nedaplatin (D1) chemotherapy, every 28 days
干预措施: Gefitinib and Pemetrexed/platinum (Drug)
Gefitinib mono-therapy
Active Comparator
Gefitinib 250mg is Taken Orally everyday
干预措施: Gefitinib mono-therapy (Drug)
结局指标
主要结局
iPFS(intracranial progression free survival
时间窗: 2 years
defined as time from randomization to intracranial progressive disease or death.
次要结局
- ORR(2 years)
- intracranial objective response rate (iORR)(2 years)
- PFS(Progression Free Survival)(2 years)
- OS(Overall Survival)(3 years)
- adverse events(3 years)
研究者
Li-kun Chen
medical doctor
Sun Yat-sen University
研究点 (1)
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