NCT04500535已完成不适用
A Multi-Center, Longitudinal, Prospective, Observational, Multi-Cohort Study of Patients With Advanced Non-Small Cell Lung Cancer Treated With Nivolumab in France After at Least One Prior Chemotherapy-based Treatment (LIST, Lung Initiative on Sequence Therapy)
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 535 人开始时间: 2020年9月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 535
- 试验地点
- 1
- 主要终点
- Time to treatment failure (TTF)
研究概览
简要总结
The purpose of this trial is to describe the following, for each cohort, in real world conditions in France:
- The characteristics and treatment sequence of patients treated with nivolumab
- The effectiveness of nivolumab treatment
- The safety profile of nivolumab
- Treatment patterns (e.g. duration of treatment, subsequent treatments) of nivolumab
- The patient-reported outcomes (PRO) in patients treated with nivolumab, at baseline and during follow up using the EuroQoL-5D-3L
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
- 是
入选标准
- •Pathologically confirmed diagnosis of advanced NSCLC
- •Whose physician has already decided to initiate a treatment with nivolumab for the treatment of advanced NSCLC according to the European label
- •Previously treated with at least one prior chemotherapy- containing regimen
排除标准
- •Participants taking part in an interventional study for lung cancer treatment for which nivolumab is one of the investigational drugs
- •Participants with a diagnosis of another primary cancer within the past five years
- •Participants receiving IO within 12 weeks prior to nivolumab first infusion in the context of the present study
- •Other protocol-defined inclusion/exclusion criteria apply
结局指标
主要结局
Time to treatment failure (TTF)
时间窗: Up to 3 years
次要结局
- Incidence of AE duration(Follow-up period (Week 4 to Week 156))
- Overall survival (OS)(Up to 3 years)
- Distribution of clinical characteristics: EGFR mutation(Index date (treatment initiation date for each individual patient))
- Progression-free survival (PFS)(Up to 3 years)
- Distribution of participant demographics characteristics: Age(Index date (treatment initiation date for each individual patient)
- Time to next therapy (TTNT)(Up to 3 years)
- Best overall response rate (BORR)(Up to 3 years)
- Distribution of clinical characteristics: TNM classification(Index date (treatment initiation date for each individual patient))
- Distribution of clinical characteristics: HER2 mutation(Index date (treatment initiation date for each individual patient))
- Incidence of Seriousness criteria(36 months after nivolumab treatment initiation)
- Distribution of clinical characteristics: ROS1 mutation(Index date (treatment initiation date for each individual patient))
- Distribution of participant demographics characteristics: Sex(Index date (treatment initiation date for each individual patient))
- Distribution of clinical characteristics: Histology(Index date (treatment initiation date for each individual patient))
- Distribution of clinical characteristics: Location of metastases(Index date (treatment initiation date for each individual patient))
- Distribution of clinical characteristics: ALK translocation(Index date (treatment initiation date for each individual patient))
- Distribution of clinical characteristics: MET mutation(Index date (treatment initiation date for each individual patient))
- Distribution of clinical characteristics: PD-L1 expression on tumor or stromal cells(Index date (treatment initiation date for each individual patient))
- Incidence of Action taken regarding the BMS treatment(Follow-up period (Week 4 to Week 156))
- Distribution of clinical characteristics: Smoking status(Index date (treatment initiation date for each individual patient))
- Distribution of clinical characteristics: ECOG at initial diagnosis and at nivolumab initiation(Index date (treatment initiation date for each individual patient))
- Distribution of clinical characteristics: BRAF mutation(Index date (treatment initiation date for each individual patient))
- Distribution of clinical characteristics: KRAS mutation(Index date (treatment initiation date for each individual patient))
- Incidence of Intensity/ Grade(36 months after nivolumab treatment initiation)
- Distribution of clinical characteristics: PD-L1 expression(Index date (treatment initiation date for each individual patient))
- Incidence of Adverse Drug Reactions(36 months after nivolumab treatment initiation)
- Incidence of Incidence rate(Follow-up period (Week 4 to Week 156))
研究者
研究点 (1)
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