NL-OMON44922招募中2 期
A phase II multicenter, single-arm study of MPDL3280A in patients with PD-L1 positive locally advanced or metastatic non small cell lunch cancer - NSCL cancer
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 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
- •Age >= 18 years
- •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
- •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;For more detailed information please refer to protocol section 4.1
排除标准
- •Cancer-Specific Exclusions
- •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;For more detailed information please refer to protocol section 4.1
研究者
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