AI-HOPE Lung Cancer: Building a Predictive Tool for Metastatic Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Early progressive disease
研究概览
简要总结
The goal of our project is building a predictive response algorithm for patients with metastatic lung cancer, exploiting an artificial intelligence platform. It will collect patient information from all areas (clinical, laboratory, radiological, pathological) and analyse them, understanding connections and correlations, both at baseline and at pre-specified timepoints. It would lead to the development of a reliable and constantly evolving predictive score, able to continuously re-weight the importance of each variable as new data come in.
Since the greatest clinical need is identifying non-responders to immunotherapy and chemo-immunotherapy combination (30% of all treated patients), these two populations are defined as the starting cohorts (Cohort A, immunotherapy alone, Cohort B, chemo-immunotherapy combinations).
For each cohort, three main questions are to be answered:
Q1) Early progressors (defined as progressive disease or death within three months of treatment or at first radiological restaging) Q2) Toxicity (with a special focus on severe toxicities G≥3) Q3) Long survivors (defined as patients reaching an overall survival of at least 1.5x median overall survival in registrative trials)
The early identification of non-responders, high-risk patients (or on the other hand, long survivors) would help their healthcare planning, providing individualised follow-up strategies or prompting their inclusion in alternative treatments (eg clinical trials).
For all cohorts, first data entry will be retrospective and second data entry will be prospective (as validation set).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Mono-immunotherapy
Patients with NSCLC stage IV treated with immunotherapy alone as first-line treatment
干预措施: Immunotherapy (Drug)
Chemo-immunotherapy
Patients with NSCLC stage IV treated with chemo-immunotherapy as first-line treatment
干预措施: Immunotherapy (Drug)
Chemo-immunotherapy
Patients with NSCLC stage IV treated with chemo-immunotherapy as first-line treatment
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Early progressive disease
时间窗: From date of enrolment until the date of first documented disease progression or death, whichever comes first, assessed within 8 to 12 weeks from first-line treatment start
Number of patients experiencing progressive disease (PD) as best response to first-line treatment
Lung toxicity
时间窗: From date of enrolment until the date of first documented immune-related pneumonitis of G3 or more, assessed up to 96 months
Number of patients experiencing immune-related pneumonitis of G3 or more
Long survivors
时间窗: At a 3-year cut-off
Numbero of patients experiencing an overall survival (time from treatment initiation to death) longer than 3 years (1.5x median overall survival from clinical trials)
次要结局
未报告次要终点
研究者
Francesca Rita Ogliari
Principal investigator, Medical doctor
IRCCS San Raffaele
