EUCTR2013-000177-69-BE进行中（未招募）1 期
A PHASE II, MULTICENTER, SINGLE-ARM STUDY OF ATEZOLIZUMAB (MPDL3280A) IN PATIENTS WITH PD-L1-POSITIVE LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 130
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
- •- Histologically or cytologically documented Stage IIIB (not eligible for definitive chemoradiotherapy), Stage IV, or recurrent NSCLC
- •- PD-L1-positive status as determined by an IHC assay performed by a central laboratory
- •- ECOG performance status of 0 or 1
- •- Measurable disease, as defined by RECIST v1.1
- •- For female patients of childbearing potential, agreement (by patient) to remain abstinent (refrain from heterosexual intercourse) or to use highly effective form(s) of contraception (i.e., one that results in a low failure rate [< 1% per year] when used consistently and correctly) during the treatment period and to continue its use for 5 months after the last dose of atezolizumab
- •Inclusion Criteria Unique to Cohort 1:
- •- No prior chemotherapy for locally advanced or metastatic (i.e., Stage IIIB not eligible for definitive chemoradiotherapy, Stage IV, or recurrent) NSCLC
- •Inclusion Criteria Unique to Cohorts 2 and 3
- •- Disease progression during or following prior platinum-based chemotherapy for locally advanced or metastatic (i.e., Stage IIIB not eligible for definitive chemoradiotherapy, Stage IV, or recurrent) NSCLC
- •Inclusion Criteria Unique to Cohort 3
- •- Diagnosis of brain metastases by brain MRI or contrast-enhanced CT
- •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 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •- Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment
- •- Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment
- •- Known CNS disease, including treated brain metastases: Cohorts 1 and 2
- •- Leptomeningeal disease
研究者
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