JPRN-jRCTs051180008已完成1 期
A phase I study of Afatinib in Combination of Osimertinib in patients with Relapsed Non-Small Cell Lung Cancer after failure of prior Osimertinib - AfaOsi trial
Tanaka Hiroshi0 个研究点目标入组 13 人开始时间: 2018年11月8日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
研究概览
简要总结
Bombination therapy with OSI and AFA is tolerable for OSI-resistant EGFR-mutated NSCLC. However, the additional effect of AFA on OSI may be limited in OSI-resistant settings.
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)Non-small cell lung cancer proven by histology and/or cytology with EGFR active mutation
- •2)Stage IIIB, IIIC, IV or postoperative/post chmoradiation therapy recurrence
- •3)Prior Osimertinib failure
- •4)Patients who could treat with a 80mg dose of osimertinib
- •5)20 years or older
- •6)ECOG PS 0 or 1
- •7)Adequate organ function
- •8)At least one or more measurable lesion by RECIST
- •9)Written informed consent for translational research
- •10) Written informed consent
排除标准
- •1) Patients who are difficult to treat enrolled doses due to toxicity of afatinib
- •2) History of drug-induced pneumonitis/Interstitial pneumonia
- •3) Symptomatic brain metastasis/ leptomeningitis
- •4) Bone metastasis to treat by operation or radiation therapy
- •5) Uncontrollable pleural, peritoneal or pericardial effusion
- •6) Prior thoracic palliative radiotherapy within 2wks
- •7) SCLC transformation
- •8) History of active double cancer
- •9) Severe infection
- •10) Active HBV infection
- •11) No intention to birth control
- •12) Unstable psychic disorder
- •13) Under treatment of steroid therapy or immunosuppressive therapy
- •14) History of allergic reaction
- •15) Patients who treated with PD-1 or PD-L1 inhibitors within six months
- •16) Decision of ineligibility by a physician
研究者
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进行中（未招募）
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Trial to evaluate the ability of afatinib to control disease in patients with advanced non-small cell lung cancer harbouring a specific gene mutation (change) in the human epidermal growth factor 2 (HER 2)Advanced stage NSCLC, harbouring HER2 exon 20 mutationsMedDRA version: 18.0Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2014-005098-35-NLETOP (European Thoracic Oncology Platform)22