NL-OMON52991已完成不适用
A phase I/II, multicenter, open-label study of EGFRmut-TKI EGF816, administered orally in adult patients with EGFRmut solid malignancies (CEGF816X2101) - CEGF816X2101
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 5 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Female and male patients >= 18 years of age.
- •Stage IIIB/IV EGFR mutant NSCLC, histologically or cytologically confirmed.
- •Patients with controlled brain metastases may participate in the trial. See
- •protocol page 14 for details.
- •Measurable disease.
- •ECOG performance status 0, 1.
- •HBV under control and HCV negative., Specific criteria groups 1-6 (see also
- •protocol page 14-15) for phase I and II:
- •EGFR activating mutation (e.g., L858R and/or ex19del)
- •no systemic antineoplastic therapy for advanced NSCLC (no more than 1 cycle
- •of chemotherapy in the advanced setting is allowed)
- •EGFR activating mutation (e.g., L858R and/or ex19del) and
- •acquired EGFR T790M mutation
- •progressed on 1 and only 1 prior treatment with a 1st-generation EGFR TKI or
- •2nd-generation EGFR TKI
- •no more than 3 prior lines of systemic antineoplastic therapies in the
- •advanced setting
- •EGFR TKI treatment must be the last prior treatment before study entry
- •*de novo* EGFR T790M mutation (see protocol page 14-15)
- •no more than 3 prior lines of systemic antineoplastic therapies in the
- •advanced setting
- •no prior treatment with any therapy known to inhibit EGFR
- •EGFR exon 20 insertion or deletion
- •no more than 3 prior lines of systemic antineoplastic therapies in the
- •advanced setting
- •EGFR activating mutation (e.g., L858R and/or ex19del) and
- •without an acquired EGFR T790M mutation
- •progressed on 1 and only 1 prior treatment with a 1st-generation EGFR TKI or
- •2nd-generation EGFR TKI
- •no more than 3 prior lines of systemic antineoplastic therapiesin the
- •advanced setting
- •EGFR TKI treatment must be the last prior treatment before study entry
- •EGFR activating mutations (e.g., L858R or ex19del) and
- •an acquired T790M mutation
- •had treatment with a 1st/2ndgeneration EGFR TKI
- •progressed on or are intolerant to a 3rd-generation EGFR TKI
- •no more than 3 prior lines of systemic antineoplastic therapies in the
- •advanced setting
- •3rd-generation EGFR TKI treatment must be the last prior treatment before
- •study entry
排除标准
- •Interstitial pneumonitis or interstitial lung disease.
- •History of malignicity last 3 year
- •Strong inhibitors or inducers of CYP3A4/5 that cannot be discontinued 1 week
- •prior to the start of EGF816.
- •Pregnancy, lactation, inadequate contraception (males and females).
研究者
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