Assessment and Follow-up of Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Nivolumab Under the French Temporary Authorization for Use (ATU) Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 907
- 试验地点
- 72
- 主要终点
- overall survival
研究概览
简要总结
Our study sought to examine nivolumab efficacy and safety in advanced NSCLC patients treated under the Temporary Authorization for Use (ATU, compassionate use) setting and describe their long-term clinical characteristics, notably the treatments they received after nivolumab discontinuation. The profile of these patients shows greater conformity to that of a non-selected population, yet the clinical data collection does not reflect "real life" conditions and stops when treatment ends, which does not enable us to get an overview of post-immunotherapy treatments.
详细描述
Although the oncogene addiction concept has led to effective targeted treatments for certain histological non-small cell lung cancer (NSCLC) types, most patients with advanced tumors are still treated with first-line chemotherapy. In 2015, several studiess demonstrated the efficacy of nivolumab, an immunotherapy targeting immune checkpoints. In France, besides the clinical trials, this molecule has been made available in January 2015 under a Temporary Authorization for Use (ATU, compassionate use).
Our study sought to examine nivolumab efficacy and safety in advanced NSCLC patients treated under the ATU setting and describe their long-term clinical characteristics, notably the treatments they received after nivolumab discontinuation. The profile of these patients shows greater conformity to that of a non-selected population, yet the clinical data collection does not reflect "real life" conditions and stops when treatment ends, which does not enable us to get an overview of post-immunotherapy treatments.
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
- •All patients with advanced NSCLC, non-eligible for thoracic radiation therapy, having received nivolumab (at least one injection), under nominative or cohort ATU, between 23-JAN-2015 and 31-AUG-2015 (end of ATU).
排除标准
- •patients included in a biomedical research trial with nivolumab
- •patients <18 years old
- •patients included under ATU to receive nivolumab administration, but never did
- •patients with a psychiatric history that hinders the comprehension of the information leaflet
- •patients refusing their data being collected
结局指标
主要结局
overall survival
时间窗: January 2015 - December 2017
time from start of treatment to death from any cause
次要结局
- maximum toxicities of nivolumab treatment, including delayed toxicities (immune)(January 2015 - December 2017)
- efficacy of the first systemic treatment post-nivolumab(January 2015 - December 2017)
- efficacy of nivolumab(January 2015 - December 2017)