NCT04994795进行中（未招募）不适用
Deep Learning-Enabled Exploration of Predictive Signatures in a Multicenter Retrospective and Prospective Observational Study Allowing the Analysis of the Aggregation of Multimodal Clinical, Biological, Genomic and Radiomics Data Associated With the Response to Treatment and Prognosis of Patients With Stage IV Non-small Cell Lung Cancer
Sophia Genetics SAS30 个研究点 分布在 8 个国家目标入组 4,000 人开始时间: 2021年8月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 4,000
- 试验地点
- 30
- 主要终点
- Treatment response at first evaluation
研究概览
简要总结
Predicting response to therapy and disease progression in stage IV NSCLC patients treated with pembrolizumab monotherapy, chemotherapy-pembrolizumab combination therapy or chemotherapy alone in the first-line setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Adult ≥18 years old
- •Patient diagnosed with Stage IV NSCLC (de novo or earlier stage progression to stage IV)
- •Absence of oncogene activating mutations eligible patients to targeted therapy (EGFR, ALK)
- •Cohort A: Received first line treatment with pembrolizumab monotherapy
- •Cohort B: Received first line treatment with chemotherapy and pembrolizumab combination therapy
- •Cohort C: Received first line treatment with chemotherapy doublet
排除标准
- •Prior anti-cancer therapy for actual stage IV NSCLC
- •Critical data missing (e.g., PD-L1 status, baseline millimetric imaging, first evaluation millimetric imaging)
- •Patients participating in other clinical trials that modify the standard of care
结局指标
主要结局
Treatment response at first evaluation
时间窗: 6-12 weeks after treatment start
Predict treatment response at first evaluation using baseline data
次要结局
- Progression-Free Survival(Through study completion, expected 6-14 months contingent on cohort)
- Overall Survival(Through study completion, expected 8-20 months contingent on cohort)
- Time-To-Progression(Through study completion, expected 6-14 months contingent on cohort)
- Duration of Response(Through study completion, expected 6-14 months contingent on cohort)
研究者
研究点 (30)
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