LUMINIST: LUng Cancer Molecular Insights Non Interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 770
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
The recent development of therapies targeting specific biomarkers mutations is changing the standards of care and prognosis of patients with advanced NSCLC, but very few data are currently available on those emerging biomarkers. In addition, the correlation of biomarkers with patients' clinical outcomes in a standard of care setting is poorly understood. This study aims to address that need.
详细描述
The LUMINIST study will enrol patients who are ineligible for the SELECT-1 (NCT01933932) or SELECT-2 (NCT01750281)RCTs. Within this NIS patients will be followed longitudinally for treatment information and outcomes. The final dataset will enable linkage at the individual patient level of the clinical information datasets collected within LUMINIST to the exploratory biomarker data generated from samples collected as part of SELECT-1 screening. This will enable the examination of various molecular markers in patients with v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) wild-type and some KRAS mutation positive (KRAS+) patients. The LUMINIST study aims to enable the investigation of various molecular segments in NSCLC, based on patient consent and where permitted by local legislation, some of which have not yet been discovered. The availability of a longitudinal dataset of clinical information linked to tumour samples will be a valuable tool to readily assess the clinical utility of potential new biomarkers. The determination of current standards of care and outcomes in future molecular segments of interest will provide valuable new insights to the scientific community.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent from the patient or next-of-kin for deceased patient at study entry, where this is mandated by local regulations
- •Female and male adults (according to each country regulations for age of majority)
- •Patients who are not eligible or choose not to enter selumetinib SELECT-1 or SELECT-2 trials
- •Patients with confirmed histological diagnosis of NSCLC
排除标准
- •Involved in the planning and/or conduct of this study (applies to both AZ staff and/or staff at the study site)
结局指标
主要结局
Overall survival (OS)
时间窗: Up to 34 months
The Overall Survival will be calculated from the first date of each line of therapy to end of follow-up or death, whichever occurs first.
次要结局
- Progression Free survival (PFS)(Up to 34 months)
- Time to progression (TTP)(Up to 34 months)
- Patients' characteristics(Up to 34 months)
- Duration of response (DOR) (complete or partial)(Up to 34 months)
- Complete response to treatment(Up to 34 months)
- Healthcare resource utilisation (HRU)(Up to 34 months)