A Multicenter Non-Interventional Cohort Study to Evaluate the Real-World Clinical Management and Outcomes of Patients Diagnosed With ALK-Positive Advanced NSCLC Treated With Alectinib (ReAlec)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 800
- 试验地点
- 229
- 主要终点
- Investigator-Confirmed Progression-Free Survival (PFS) According to the Local Standard of Care or per Response Evaluation in Solid Tumors (RECIST) - Cohort 1
研究概览
简要总结
This study aims to characterize the clinical management and outcomes of participants diagnosed with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) who are being treated with alectinib in real-world clinical practice.
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
- •Confirmed diagnosis of advanced NSCLC (stage IIIB, IIIC, IVA, or IVB) on or after the date of local approval for alectinib as first-line treatment and/or second-line treatment for ALK-positive advanced NSCLC and planned to receive treatment as per routine for at least one cycle (28 days) while on study
- •ALK-positive as confirmed by immunohistochemistry (IHC), fluorescent in situ hybridization (FISH), next generation sequencing (NGS), or other non-specified sequencing methods, documented prior to receiving treatment with an ALK inhibitor
- •Cohort 1: Currently receiving, or planned to receive, treatment for ALK-positive advanced NSCLC with alectinib as first-line treatment
- •Cohort 2: Planned to receive treatment for ALK-positive advanced NSCLC with alectinib as second-line treatment
- •Able to be followed-up by participating site
- •Participants with advanced NSCLC who have CNS metastases are eligible for inclusion
排除标准
- •Participants not receiving alectinib for the treatment of ALK-positive advanced NSCLC according to standard of care and in line with local product information
- •Participants not receiving the Roche studied medicinal product
- •Participants who have received or are currently receiving alectinib as an investigational study drug in a clinical trial for the treatment of advanced NSCLC
研究组 & 干预措施
Cohort 1
Participants starting alectinib treatment after (Arm A) or before (Arm B) study enrollment as first-line treatment will be followed up for up to 4 years.
干预措施: Alectinib (Drug)
Cohort 2
Participants receiving alectinib as second-line treatment after study enrollment will be followed up for up to 2 years.
干预措施: Alectinib (Drug)
结局指标
主要结局
Investigator-Confirmed Progression-Free Survival (PFS) According to the Local Standard of Care or per Response Evaluation in Solid Tumors (RECIST) - Cohort 1
时间窗: From the first administration of alectinib to the date of first documentation of disease progression, or death due to any cause, whichever occurs first (up to 4 years)
Reasons for Discontinuation of Next LoT
时间窗: Up to approximately 1 year
Investigator-Confirmed PFS According to the Local Standard of Care or per RECIST - Cohort 2
时间窗: From the first administration of alectinib to the date of first documentation of disease progression, or death due to any cause, whichever occurs first (up to 2 years)
Duration of Next LoT
时间窗: Up to approximately 1 year
Choice of the Next Line of Treatment (LoT) Post-Alectinib
时间窗: Up to approximately 1 year
次要结局
- Time to Loss of Clinical Benefit (TTLCB)(From the first administration of alectinib to loss of clinical benefit as assessed by the treating physician (up to 4 years for Cohort 1 and 2 years for Cohort 2))
- Duration of Objective Response (DOR)(From first documentation of CR or PR (whichever occurs first) after the first administration of alectinib until death or progressive disease (PD) (up to 4 years for Cohort 1 and 2 years for Cohort 2))
- Time to Response(From the first administration of alectinib to first CR or PR (up to 4 years for Cohort 1 and 2 years for Cohort 2))
- Overall Survival (OS)(From the first administration of alectinib to death from any cause (up to 4 years for Cohort 1 and 2 years for Cohort 2))
- Objective Response Rate (ORR), Defined as a Complete Response (CR) or Partial Response (PR)(From the first administration of alectinib to first CR or PR (up to 4 years for Cohort 1 and Cohort 2))
- Duration of Disease Control(Time from the first administration of alectinib to the first documentation of CR, PR, or stable disease (whichever occurs first), until death or PD (up to 4 years for Cohort 1 and 2 years for Cohort 2))
- Time to Central Nervous System (CNS) Progression (Cohort 1 Arm A)(Time interval from the first administration of alectinib to the date of confirmed CNS metastases in participants with no CNS metastases at baseline (up to 4 years))
- Disease Control Rate (DCR)(At least 12 weeks after the first administration of alectinib (up to 4 years for Cohort 1 and 2 years for Cohort 2))
- Time to Initiation of Next Line of Treatment (LoT)(From the first administration of alectinib to the date of initiation of next LoT or death due to any cause, whichever occurs first (up to 4 years for Cohort 1 and 2 years for Cohort 2))
- Quality of Life Status Using the EORTC QLQ-LC13 Scores (Cohort 1 Arm A and Cohort 2)(At enrollment and every 3 months thereafter (up to 4 years for Cohort 1 and 2 years for Cohort 2))
- Quality of Life Status Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores(At enrollment and every 3 months thereafter (up to 4 years for Cohort 1 and 2 years for Cohort 2))