NCT07051928尚未招募不适用
A Prospective, Observational, Single Arm, Multi-site, Pilot Study of Atezolizumab in Non-oncogene Addicted Advanced Nsclc Patients With Pd-l1 Tps ≥ 50%, With Longitudinal Assessment of C-FLIP Expression of Monocytic Myeloid-derived Suppressor Cells
Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2025年7月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Disease-control Rate (DCR)
研究概览
简要总结
Prospective, observational, multi-site, single arm, exploratory pilot study, designed to prospectively assess the relationship between basal c-FLIP expression in M-MDSCs with clinical outcomes in patients treated with anti-PD-L1 monotherapy in a 1L mNSCLC setting, as well as evaluate changes in c-FLIP during treatment and correlate those changes with clinical outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥ 18 years at time of signing Informed Consent Form
- •ECOG Performance Status of 0-2
- •Advanced/metastatic NSCLC without prior treatment in the metastatic setting
- •Tumor PD-L1 expression with a TPS ≥ 50%, documented through local testing
- •Measurable disease per RECIST v1.1
- •Adequate hematologic and end-organ function
排除标准
- •Ineligibility to receive first line immunotherapy treatment
- •Patients with driver mutations amenable to molecular targeted therapies in I-line according to the indications of the AIFA
结局指标
主要结局
Disease-control Rate (DCR)
时间窗: 24 months
Disease-control rate at 12 weeks based on basal c-FLIP expression on MDSC
次要结局
- Progression-free survival (PFS)(24 months)
- Overall Survival (OS)(24 months)
研究者
研究点 (1)
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