JPRN-jRCTs031180136已完成2 期
First-line afatinib in patients aged 75 or older with advanced non-squamous non-small cell lung cancer harboring EGFR mutations; non-randomized phase II trial - NEJ027
Gemma Akihiko0 个研究点目标入组 38 人开始时间: 2019年2月19日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
研究概览
简要总结
First-line afatinib administered as a starting dose of 40 mg was well tolerated with dose adjustments and was associated with encouraging activity in Japanese patients aged 75 years or older with EGFR mutation-positive NSCLC.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 75age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Histologically or cytological confirmed stage III/IV non-small cell lung cancer
- •2. Patients having EGFR mutation (exon 19 deletion or L858R)
- •3. No prior chemotherapy and no prior treatment with EGFR targeting small molecules or antibodies.
- •4. Measurable lesion for RECIST(ver 1.1)
- •5. Patients aged 75 years or older
- •6. ECOG performance status 0 to1
- •7. Adequate organ function
- •8. Life expectancy more than three months
- •9. Written informed consent
排除标准
- •1. Chemotherapy, biological therapy or investigational agents for other carcinomas within four weeks prior to the start of study treatment. Hormonal treatment within 2 weeks prior to start of study treatment
- •2. Previous radiotherapy to the primary tumor or mesurable lesion
- •3. Major surgery within 4 weeks before starting study treatment or scheduled for surgery during the projected course of the study
- •4. Patients with active lung disease such as interstitial pneumonia, active radiation pneumonitis, or drug-induced pneumonitis
- •5. Massive pleural or pericardial effusion, or ascites
- •6. Symptomatic brain metastases
- •7. Any history or presence of poorly controlled diseases that could affect the absorption of the study drug
- •8. Active infection, active hepatitis B infection, active hepatitis C infection and/or known HIV carrier.
- •9. Other concurrent active malignancy
- •10. Any history or presence of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug
- •11. Pregnancy
- •12. Clinically significant phycological problem
- •13. Patients with uncontrollable complications
- •14. Known hypersensitivity to afatinib or the excipients of any of the trial drugs
研究者
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