NCT03755102已完成早期 1 期
A Pilot Study of Dacomitinib With or Without Osimertinib for Patients With Metastatic EGFR Mutant Lung Cancers With Disease Progressionon Osimertinib.
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 8
- 主要终点
- Overall Response Rate
研究概览
简要总结
The purpose of this study is to assess whether dacomitinib after osimertinib is effective in participants with metastatic EGR-mutant lung cancers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Advanced biopsy-proven metastatic non-small cell lung cancer
- •Somatic activating mutation in EGFR in a tumor biopsy or plasma cfDNA liquid biopsy
- •Prior treatment with osimertinib with response followed by disease progression
- •No prior first or second generation EGFR inhibitor treatment (gefitinib, afatinib, erlotinib)
- •Archival tissue available from a tumor biopsy done after disease progression on osimertinib or willing to undergo a tumor biopsy or liquid biopsy after disease progression on osimertinib prior to study initiation
- •Measurable (RECIST 1.1) indicator lesion not previously irradiated
- •Karnofsky performance status (KPS) >/= 70%
- •Age >/= 18 years old
- •Ability to swallow oral medication
- •Adequate organ function
- •AST, ALT </= 3 x ULN
- •Total bilirubin </= 1.5x ULN
- •Creatinine </= 1.5x ULN OR calculated creatinine clearance >/= 60ml/min
- •Absolute neutrophil count (ANC) >/= 1000 cells/mm3
- •Hemoglobin>/=8.0 g/dL
- •Platelets >/=75,000/mm3
排除标准
- •Pregnant or lactating women
- •Any radiotherapy within 1 week of starting treatment on protocol.
- •Any major surgery within 1 weeks of starting treatment on protocol.
- •Any evidence of active clinically significant interstitial lung disease
- •Continue to have unresolved > grade 1 toxicity from any previous treatment Treatment
- •Patients with a known mechanism of resistance to osimertinib that will clearly not respond to dacomitinib therapy (i.e. known MET amplification, ALK fusion, RET fusion).
- •Symptomatic brain metastases or leptomeningeal disease requiring escalating doses of steroids
研究组 & 干预措施
Cohort 1: Participants treated with dacomitinib alone
Experimental
Participants in this cohort have a somatic activating mutation in EGFR in a tumor biopsy or plasma cfDNA liquid biopsy.
干预措施: Dacomitinib (Drug)
Cohort 2: Participants treated with dacomitinib in combination with osimertinib
Experimental
Participants in this cohort have a secondary acquired EGFR mutation in addition to the sensitizing mutation
干预措施: Dacomitinib (Drug)
Cohort 2: Participants treated with dacomitinib in combination with osimertinib
Experimental
Participants in this cohort have a secondary acquired EGFR mutation in addition to the sensitizing mutation
干预措施: Osimertinib (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: 1 year
Overall response rate (partial and complete responses) of dacomitinib in participants with EGFR-mutant lung cancers and disease progression on osimertinib
次要结局
- Progression-free survival(1 year)
- Overall survival(1 year)
研究者
研究点 (8)
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