NCT06735781已完成不适用
Short-term Clinical Outcomes of Patients With Resectable Non-Small Cell Lung Cancer Receiving Nivolumab Plus Chemotherapy as Neoadjuvant Therapy in France
Bristol-Myers Squibb7 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2024年9月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 7
- 主要终点
- Rate of pathological complete response on date of surgery
研究概览
简要总结
The purpose of this study is to evaluate real-world effectiveness of neoadjuvant nivolumab plus chemotherapy in France.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Having a diagnosis of resectable non-small cell lung cancer (NSCLC)
- •Being 18 years or above at the time of their NSCLC diagnosis
- •Having initiated a neoadjuvant treatment with nivolumab and chemotherapy outside a clinical trial
- •Being indexed in the site database
- •Being followed at the site for at least 5 months, except for patients with a record of death
排除标准
- •Having any primary tumor other than NSCLC on or before the date of NSCLC diagnosis that required a treatment ending less than 12-months before the nivolumab plus chemotherapy neoadjuvant treatment
研究组 & 干预措施
Neoadjuvant nivolumab plus chemotherapy treatment
干预措施: Nivolumab (Drug)
结局指标
主要结局
Rate of pathological complete response on date of surgery
时间窗: Up to 31 months (until loss of follow-up, death, or end of study observation period)
次要结局
- Duration of nivolumab treatment(Up to 31 months (until loss of follow-up, death, or end of study observation period))
- Study population baseline demographics(Baseline)
- Surgery rate(Up to 31 months (until loss of follow-up, death, or end of study observation period))
- Time from diagnosis to start of neoadjuvant treatment(Up to 31 months (until loss of follow-up, death, or end of study observation period))
- Average dose of nivolumab infusions(Up to 31 months (until loss of follow-up, death, or end of study observation period))
- Frequency of nivolumab infusions(Up to 31 months (until loss of follow-up, death, or end of study observation period))
- Study population baseline clinical characteristics(Baseline)
- Type of chemotherapy received in combination with nivolumab treatment as neoadjuvant treatment(Up to 31 months (until loss of follow-up, death, or end of study observation period))
- Infusion setting (hospital or at home)(Up to 31 months (until loss of follow-up, death, or end of study observation period))
- Survival status(at 3, 6, 9, 12, 18, and 24 months (or until loss of follow-up, death, or end of study observation period (31 months)))
- Subsequent treatments received after nivolumab treatment(Up to 31 months (until loss of follow-up, death, or end of study observation period))
- Disease progression/relapse status(At 3, 6, 9, 12, 18, and 24 months (or until loss of follow-up, death, or end of study observation period (31 months)))
- Rate of major pathological response(Up to 31 months (until loss of follow-up, death, or end of study observation period))
- Adverse events(Up to 31 months (until loss of follow-up, death, or end of study observation period))
- Time to surgery from initial diagnosis(Up to 31 months (until loss of follow-up, death, or end of study observation period))
- Time to surgery from the first dose of neoadjuvant therapy(Up to 31 months (until loss of follow-up, death, or end of study observation period))
- Time to surgery from the last dose of neoadjuvant therapy(Up to 31 months (until loss of follow-up, death, or end of study observation period))
- Surgery type(Up to 31 months (until loss of follow-up, death, or end of study observation period))
- Extent of surgical resection(Up to 31 months (until loss of follow-up, death, or end of study observation period))
- Duration of surgery(Up to 31 months (until loss of follow-up, death, or end of study observation period))
- Rate of lymph node resection(Up to 31 months (until loss of follow-up, death, or end of study observation period))
- Type of surgery complications(Up to 31 months (until loss of follow-up, death, or end of study observation period))
- Length of hospital stay(Up to 31 months (until loss of follow-up, death, or end of study observation period))
- Reasons for not having surgery as indicated by the multi-disciplinary tumor board(Up to 31 months (until loss of follow-up, death, or end of study observation period))
研究者
研究点 (7)
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