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 - First-line afatinib for elderly patients

on Profit Organization North East Japan Study Group0 个研究点目标入组 38 人开始时间: 2015年8月1日最近更新: 2023年10月17日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 38

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

Patients characteristics N=38 (SAS) Gender:Male/Female 12/23 Age:median(range) 77 (75-91) years Smoking status:Never 26(68.4%) ECOG PS:0/1 21/17 EGFR mutation type:ex19del/L858R 23/15 Promary endpoint Objective response rate:75.7% (95%CI 58.8-88.2%) Secondary endpoint Disease control rate:33% (74.6-97.0%) Adverse event: All garade 100%, grade3/4 63.2% Grade5 0%

研究设计

研究类型: Interventional

入排标准

年龄范围: 75years-old 至 ot applicable（—）
性别: All

入选标准

未提供

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

发起方

on Profit Organization North East Japan Study Group

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