Crizotinib in ALK Rearranged Non-small-cell Lung Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 23
- 主要终点
- Sistematic review of medical records
研究概览
简要总结
This is a multicenter, observational, retrospective cohort study aimed at assessing the efficacy and safety of crizotinib in ALK positive NSCLC treated in real life setting.
详细描述
Primary efficacy objective:
To assess the efficacy of crizotinib in real life setting
Secondary objectives:
- To evaluate the therapeutic response to crizotinib-based treatment
- To identify additional biomarkers selectively present in the ALK positive population
- To assess the safety of crizotinib (250 mg/bid) in the treatment of NSCLC in real life setting
Non-small-cell Lung Cancer (NSCLC) remains the leading cause of cancer death in Western Countries. Identification of anaplastic lymphoma kinase (ALK) gene rearrangements reinforced the role of targeted therapies in lung cancer. The EML4-ALK fusion gene is detected in 3-7% of patients with adenocarcinomas of the lung and is associated with specific clinical pathological features, including young age, absent or minimal smoking history and adenocarcinoma histology. However, such clinical features do not properly select patients for ALK inhibitors (ALK-Is) and, consequently, molecular testing is mandatory. Indeed, current guidelines recommend to test ALK rearrangements at diagnosis all patients with advanced lung adenocarcinoma, due to immediate therapeutic implications.
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
- •Males and Females aged 18 years with diagnosis of advanced or metastatic NSCLC
- •Former participation in the Italian NPU program between December 2010 - April 2013 or receiving crizotinib according to 648 legislative Decrete from April 2013 to February 2015 and thereafter in clinical practice up to December 31st,
- •Ascertained compliance to the Crizotinib therapy as prescribed by the relevant physician
- •ALK rearrangement report including details of method and cutoff used for ALK testing
- •Data on prior therapies
- •Data on toxicity
- •Data on crizotinib therapy efficacy including response to the therapy and survival
- •Data on site of metastases
- •Availability of archival tissue (not mandatory)
- •Signed Informed Consent for alive and contactable patients
排除标准
- •Lack of clinical data
- •No evidence of ALK rearrangemement
- •Early death defined as fatal outcome within 30 days since the first crizotinib dose
- •Absence of any radiological assessment
- •No data on crizotinib efficacy including survival
结局指标
主要结局
Sistematic review of medical records
时间窗: Six months
To assess the overall efficacy of crizotinib (250 mg/bid) in terms of Response rate, Progression-Free Survival and Overall Survival in the treatment of NSCLC in real life setting. Median PFS, as reported by a recent metanalysis, is 9.4 months (first and second line together) corresponding to a 12 months PFS rate of about 40%. The analysis of 500 patients will allow to estimate the median PFS with a semi-width 95% confidence interval of 1.2 months. OS will be calculated from the first day of treatment until the date of death from any cause. Any patient not known to have died at the time of data analysis will be censored at the time of the last recorded date on which the patient was known to be alive. Time to events will be summarized using Kaplan-Meier estimation. ORR, defined as the proportion of patients with a best overall response of either Complete response or Partial response, will be calculated based on disease status evaluated by the investigator according to RECIST v1.1
次要结局
- Secondary Objectives(Six months)