JPRN-jRCTs051180205已完成2 期
Afatinib plus Bevacizumab Combination after osimertinib failure for aDvanced EGFR-mutant non-small cell lung cancer: a multicenter prospective single arm phase II study (ABCD-study/HANSHIN Oncology Group 0217 trial) - ABCD-study
Hata Akito0 个研究点目标入组 28 人开始时间: 2019年3月27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
- 28
研究概览
简要总结
Afatinib + bevacizmab after Osimertinib resistance demonstrated moderate efficacy and favorable safety. - A small portion of C797S patients exhibited sensitivity. - Higher potency was suggested in T790M/BRAF/KRAS/PI3K mutation-negative and uncommon EGFR/HER2 mutation positive patients. - Selected population could obtain clinical benefit from Afatinib + bevacizmab, based on rebiopsy results after Osimertinib resistance.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Histologically or cytologically proven non-small cell lung cancer
- •2) EGFR-mutant
- •3) After osimertinib failure (after CR/PR or SD longer than 6 months)
- •4) Blood samples after osimertinib failure are available.
- •5) 4 weeks has passed since completion of thoracic radiation
- •6) Aged more than 20
- •7) ECOG PS 0 or 1
- •8) With evaluable lesions by RECIST
- •9) Adequate organ functions
- •10) Life expectancy longer than 3 months
- •11) Written informed consent
排除标准
- •1) Interstitial lung disease or pulmonary fibrosis by chest CT
- •2) Symptomatic CNS metastases
- •3) History of severe allergy
- •4) Severe infection of comorbidities
- •5) Uncontrolled pleural, abdominal, and/or cardiac effesion
- •6) Severe heart disease
- •7) Uncontrolled hypertension
- •8) Uncontrolled diabetes
- •9) Active double cancer
- •10) Squamous histology
- •11) Severe mental illness
- •12) Massive hemoptysis
- •13) History of GI perfolation
- •14) Incurable bone fracture
- •15) Planning surgery during the trial
- •16) Bleeding tendecy
- •17) Uncontrolled thromboembolizm
- •18) Receiving EGFR-TKIs or immunotherapies after osimertinib failure
- •19) Pregnant women
- •20) unproper patients for the clinical trial
研究者
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