Efficacy of Treatment Sequences in Patients With ALK and ROS-1 Positive Non-small Cell Lung Cancer Who Received Lorlatinib as Part of the French Expanded Access Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 291
- 试验地点
- 30
- 主要终点
- Progression free survival
研究概览
简要总结
The study will evaluate progression-free survival, overall survival, best response and duration of treatment in patients with advanced ALK- and ROS1-positive non-small cell lung cancer who received lorlatinib as part of the French expanded access program.
详细描述
IFCT-1803 LORLATU study will evaluate progression-free survival, overall survival, best response and duration of treatment in patients with advanced ALK- and ROS1-positive non-small cell lung cancer who received lorlatinib (PF-06463922) as part of the French expanded access program. Those outcomes will be correlated to clinical, pathological, and radiological characteristics of patients.
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
- •Patients with histologically or cytologically confirmed locally advanced or metastatic NSCLC (Stage IIIB or IV accordingly to American Joint Committee on Cancer [AJCC] classification) at time of lorlatinib initiation
- •Patients who received at least one week of treatment with lorlatinib as part of the French Expanded Access Program (ATU program); ATU was granted due to their inability to meet eligibility criteria for on-going recruiting trials, inability to participate in other clinical trials (e.g., poor performance status, lack of geographic proximity), or because other medical interventions are not considered appropriate or acceptable.
排除标准
- •Patients enrolled in a lorlatinib clinical trial
结局指标
主要结局
Progression free survival
时间窗: October 2015 - December 2019
time from first dose of treatment to first occurrence of disease progression or death from any cause during the study
次要结局
- Duration of treatment(October 2015 - December 2019)
- Best response(October 2015 - December 2019)
- Duration of treatment beyond progression(October 2015 - December 2019)
- Overall Survival(October 2015 - December 2019)
- Pattern of tumor progression(October 2015 - December 2019)
- Central Nervous System (CNS) best response(October 2015 - December 2019)
- Adverse Events(October 2015 - December 2019)
- Reason for treatment discontinuation(October 2015 - December 2019)
- Central Nervous System (CNS) Progression free survival(October 2015 - December 2019)