Global PANORAMA Real World Molecular Testing, Treatment Patterns, and Clinical Outcomes in Patients With Locally Advanced or Metastatic NSCLC.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Parameters in the target population associate with molecular testing patters
研究概览
简要总结
This is an observational cohort study of patients with locally advanced or metastatic NSCLC (non-small cell lung cancer).
Patients will be recruited from participating sites in Europe, Asia, and Canada. The study will include 2 patient cohorts.
详细描述
Study Design This will be an observational cohort study of patients with locally advanced or metastatic NSCLC (non-small cell lung cancer).
Patients will be recruited from participating sites in Europe, Asia, and Canada. Patients meeting the study inclusion/exclusion criteria will be selected during a 24-month enrolment period per country and will be followed from enrolment in the study until death, loss to follow-up, withdrawal of consent or study end date (whichever occurs earlier). Data Sources Data will be collected following enrolment in the study and entered in the electronic case report form (eCRF). All data will be collected using patient medical records. The investigator will be responsible for ensuring that all the required data is collected and entered into the eCRF. The site will collect the patient questionnaires and the data will be uploaded according to the data entry procedures.
Study Population
- Adult male or female patients (according to age of majority/adulthood as defined by local regulations) who have given written informed consent as per local regulations.
- The primary cohort will include patients with EGFR (epidermal growth factor receptor) mutation-positive locally advanced or metastatic NSCLC who have progressed while on or after receiving front-line EGFR-TKI (tyrosine kinase inhibitors) therapy (e.g., gefitinib, erlotinib, afatinib, or icotinib).
- Additionally, a secondary cohort of patients will include patients newly diagnosed with locally advanced or metastatic NSCLC who are treatment naive or patients who were diagnosed at an earlier stage but have progressed to metastatic NSCLC during the selection period.
Exposures There are no specific drug exposures or interventions being evaluated, as cohort eligibility (for both cohorts) is not exposure-based, but rather disease-based. All molecular testing and treatments will be at the discretion of the treating physician. Study Measures and Outcomes
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Provision of written informed consent - patient consent should be within 6 weeks of index date.
- •Adult male or female subjects (according to age of majority/adulthood as defined by local regulations)
排除标准
- •Enrolment in studies that prohibit any participation in this non interventional study
结局指标
主要结局
Parameters in the target population associate with molecular testing patters
时间窗: Patients will be followed from enrolment in the study until death, loss to follow-up, withdrawal of consent or study end date. The minimum follow-up will be 12 months and the maximum allowed follow-up will be 36 months
* Molecular testing rate defined as the number of patients identified as having received molecular testing divided by the number of patients in the cohorts * Changes in testing rates over time (details will be included in the SAP) * Molecular testing details including, but not limited to sample type, method of biopsy, testing turnaround time, test type, reason for testing, testing laboratory type, reason for not performing a test * Molecular testing results including mutation status and type, test outcome, histologic/phenotypic transformation
Parameters in the target population associate with treatment patterns and associated clinical outcomes
时间窗: Patients will be followed from enrolment in the study until death, loss to follow-up, withdrawal of consent or study end date. The minimum follow-up will be 12 months and the maximum allowed follow-up will be 36 months
* Overall survival measured from: * the date of initial diagnosis to date of death from any cause to the index date to date of death from any cause (for primary cohort only) * the date of first-line treatment until death * the date of second-line treatment until death * Overall disease progression: o from date of treatment initiation until physician-reported progression, initiation of a new cancer-directed line of therapy (proxy for progression), or death * For each line of chemotherapy/targeted therapy received: * Therapy regimen * Therapy duration measured as time from therapy start date to time of therapy end date * Number of cycles received * Reason for cessation of therapy * Time to initiation of new therapy defined as the time from start date of current therapy to start date of subsequent therapy * For each surgery or radiotherapy received: * Type * Site * Date * Any palliative/supportive care received
次要结局
- Estimation of parameters in the target population associate with cancer-related health care utilization patters including inpatient, emergency room, outpatient visits, lenght of inpatient stay(Patients will be followed from enrolment in the study until death, loss to follow-up, withdrawal of consent or study end date. The minimum follow-up will be 12 months and the maximum allowed follow-up will be 36 months)
- Estimation of parameters in the target population associated with treatment- and biopsy-related complications(Patients will be followed from enrolment in the study until death, loss to follow-up, withdrawal of consent or study end date. The minimum follow-up will be 12 months and the maximum allowed follow-up will be 36 months)
- Assessment of patient (HRQoL) using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 items (EORTC QLQ-C30) and EORTC QLQ - Lung Cancer 13 items (EORTC QLQ-LC13)3(Patients will be followed from enrolment in the study until death, loss to follow-up, withdrawal of consent or study end date. The minimum follow-up will be 12 months and the maximum allowed follow-up will be 36 months)
- Estimation of the rate of CNS metastases in the target population including brain metastases and leptomeningeal metastases and treatments associated with CNS metastases(Patients will be followed from enrolment in the study until death, loss to follow-up, withdrawal of consent or study end date. The minimum follow-up will be 12 months and the maximum allowed follow-up will be 36 months)