EUCTR2015-005156-94-ES进行中（未招募）1 期
Protocol I3Y-MC-JPCEA Phase 2 Study of Abemaciclib in Combination with Pembrolizumab for Patients with Stage IV Non-Small Cell Lung Cancer or Hormone Receptor Positive, HER2 Negative Breast Cancer
illy S.A.0 个研究点目标入组 75 人开始时间: 2016年4月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Part A: NSCLC, KRASmt, PD-L1+; Chemotherapy naïve for metastatic NSCLC
- •Part B: NSCLC, squamous subtype; Must have received 1 prior therapy containing platinum based chemotherapy for metastatic NSCLC
- •Part C: HR+, HER2- breast cancer; Must have received at least 1 but no more than 2 chemotherapy regimens for metastatic breast cancer
- •All patients: amendable to provide tumor tissue prior to treatment and during treatment; ECOG PS <= 1;
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 37
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 38
排除标准
- •-Have CNS metastasis with associated neurological changes 14 days prior to receiving study drug
- •-QTc interval of >470msec on screening ECG
- •-History of interstitial lung disease or pneumonitis
- •-Active autoimmune disease or other syndrome that requires systemic steroids or autoimmune agents for the past 2 years
- •-Recently treated with an anti-PD-1 or PD-L1 or anti-CTLA-4 agent
- •-Previously received treatment with any CDK4 or CDK6 inhibitor
研究者
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