NCT01714908Unknown2 期
A Multicenter, Randomized, Open-label, Phase II Study to Evaluate the Efficacy and Safety of Erlotinib Versus Etoposide Plus Cisplatin With Concurrent Radiotherapy in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) With Activating Mutation of Epidermal Growth Factor Receptor (EGFR) in Exon 19 or 21
Jinming Yu19 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年12月14日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 19
- 主要终点
- Progress Free Survival (PFS)
研究概览
简要总结
Erlotinib with concurrent radiotherapy has superior efficacy and comparable safety profile in unresectable stage III non-small cell lung cancer (NSCLC) patients with activating mutation of epidermal growth factor receptor (EGFR) in exon 19 or 21 versus etoposide plus cis-platin with concurrent radiotherapy.
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
- •NSCLC confirmed by histopathology or cytology;
- •Stage IIA or IIIB NSCLC according to Tumor Node Metastasis (TMN) staging of Lung Staging Standard version 7 2009, and be unresectable;
- •Has active mutation of EGFR in exon 19 or 21;
- •Has measurable lesion [according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, must have at least one evaluable lesion with the longest dimension >= 10mm; if the evaluable lesion is lymph node, the shortest dimension should be measured and >=15mm];
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
- •expectancy life >= 12 weeks;
排除标准
- •Had be treated by HER-targeting agents;
- •Had systemic anit-NSCLC treatments;
- •Had local radiotherapy for NSCLC;
- •Has upper gastrointestinal physiological disorders, or malabsorption syndrome, or intolerance of oral medication, or active peptic ulcer;
- •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);
- •Any evidence to indicate moderate or severe chronic obstructive pulmonary disease (COPD);
- •Known hypersensitivity to platinum, etoposide, EGFR-Tyrosine Kinase Inhibitor (TKI) agents or relevant components in the formulation;
- •Uncontrolled eye inflammation or infection, or any potential circumstances lead to eye inflammation or infection;
结局指标
主要结局
Progress Free Survival (PFS)
时间窗: 5 years
The time frame from the randomization to the first confirmed disease progression or any cause to death (dependent on which comes first)
次要结局
未报告次要终点
研究者
Jinming Yu
Professor
Shandong Cancer Hospital and Institute
研究点 (19)
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