EUCTR2011-002168-26-LV进行中（未招募）不适用
OPEN LABEL STUDY OF ERLOTINIB (TARCEVA®) AS SINGLE AGENT FIRST LINE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC LUNG ADENOCARCINOMA WITH ACTIVATING EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) MUTATIONS
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 68
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Histologically or cytologically documented diagnosis of inoperable, locally advanced, recurrent or metastatic (Stage IIIB or Stage IV) lung adenocarcinoma.
- •NSCLC with an activating EGFR mutation (exon 19 microdeletions or exon 21 L858R point mutation) by using Cobas® 4800 EGFR mutation testing kit at a designated central laboratory.
- •Eastern Cooperative Oncology Group Performance Status of 0-2.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Prior chemotherapy or other systemic anti-cancer treatment. Neoadjuvant/adjuvant chemotherapy is allowed, if completed more than 6 months prior to study treatment. Prior radiochemotherapy is allowed, if completed more than 6 months before start of study treatment. Palliative radiotherapy must be completed at least 4 weeks before start of study treatment.
- •Prior therapy with systemic anti-tumor therapy with HER1/EGFR inhibitors.
- •Radical radiotherapy with curative intent within 28 days prior to enrolment.
- •Patients are excluded if they have brain metastasis or spinal cord compression that has not yet been definitively treated with surgery and/or radiation; patients previously diagnosed and treated central nervous system (CNS) metastases or spinal cord compression without evidence of stable disease (clinically stable imaging) for at least 2 months will also cause patients to be excluded.
- •Any inflammatory changes of the surface of the eye
研究者
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