An Observational Parallel Group Phase 4 Study to Determine Progression-Free Survival and Evaluate Patient Experience for Patients With Metastatic ALK+ Non-Small Cell Lung Cancer (NSCLC) Treated With ALK Inhibitors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Prescriber-confirmed PFS
研究概览
简要总结
The primary purpose of this study is to determine the differences in PFS for participants who have been receiving brigatinib as ALK inhibitor therapy for ALK+NSCLC compared to those participants receiving alectinib, ceritinib, lorlatinib, or other ALK inhibitors that may become available during study treatment.
详细描述
This is a prospective and non-interventional study of participants with ALK+NSCLC. The study will seek to determine the real-world differences in the PFS of participants taking brigatinib or any FDA approved ALK inhibitor other than crizotinib in routine clinical practice and will evaluate participant's quality of life, daily function, general condition, and treatment satisfaction.
The study will enroll approximately 160 participants: 80 participants taking brigatinib, and 80 participants taking FDA approved ALK inhibitors other than crizotinib. Participants will be enrolled in one of the 2 cohorts:
- Brigatinib
- Any FDA Approved ALK Inhibitor Other Than Crizotinib
This trial will be conducted in the United States. Upon enrollment into the study, participants will complete a study-specific baseline questionnaire and four validated instrument questionnaires. After that, participants will complete a study-specific monthly questionnaire and four validated instrument questionnaires, which will be made available to participants every 30 days. Participants will be sent automatic e-mail reminders every 30 days when new surveys become available. All participants will receive a notice on completion of their participation in the study at approximately 24 months.
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
- •Has ALK+ NSCLC.
- •Has been prescribed:
- •Brigatinib at any point in therapy, OR
- •Any FDA approved ALK inhibitor at any point in therapy other than crizotinib. Participants who were previously on crizotinib, but are now on another ALK inhibitor are eligible for study participation.
- •Has internet access.
- •Is willing to answer regular e-surveys and allow for the prescriber or clinic to provide data on the status of the participant's NSCLC.
排除标准
- •Has received any investigational compound within 90 days prior to consent.
研究组 & 干预措施
Brigatinib
The dosage and regimen of brigatinib (ALK inhibitors) will be decided by participant's prescribing physician and will not be determined by participation in the study.
干预措施: Brigatinib (Drug)
Any FDA Approved ALK Inhibitor Other Than Crizotinib
The dosage, regimen of any Food and Drug Administration (FDA) approved ALK inhibitor (at any point in therapy) other than crizotinib will be decided by participant's prescribing physician and will not be determined by participation in the study.
干预措施: Alectinib (Drug)
Any FDA Approved ALK Inhibitor Other Than Crizotinib
The dosage, regimen of any Food and Drug Administration (FDA) approved ALK inhibitor (at any point in therapy) other than crizotinib will be decided by participant's prescribing physician and will not be determined by participation in the study.
干预措施: Ceritinib (Drug)
Any FDA Approved ALK Inhibitor Other Than Crizotinib
The dosage, regimen of any Food and Drug Administration (FDA) approved ALK inhibitor (at any point in therapy) other than crizotinib will be decided by participant's prescribing physician and will not be determined by participation in the study.
干预措施: Lorlatinib (Drug)
Any FDA Approved ALK Inhibitor Other Than Crizotinib
The dosage, regimen of any Food and Drug Administration (FDA) approved ALK inhibitor (at any point in therapy) other than crizotinib will be decided by participant's prescribing physician and will not be determined by participation in the study.
干预措施: Any FDA Approved ALK Inhibitors (Drug)
结局指标
主要结局
Prescriber-confirmed PFS
时间窗: Baseline up to disease progression or death due to any cause, whichever comes first (approximately 24 months)
PFS is defined as the time from the date of the first administration of ALK inhibitor to the date of the first documentation of disease progression or death due to any cause, whichever comes first. PFS will be based on prescriber confirmed progression. Participants that withdraw, drop out, or are lost to follow-up before documentation of the events will be censored at the last date at which the participant was determined to be progression-free.
次要结局
- Quality of Life Status Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire -Lung Cancer (EORTC QLQ-LC13)(Baseline up to treatment cessation or up to approximately 24 months)
- Daily Function Status by M.D. Anderson Symptom Inventory - Lung Cancer (MDASI-LC)(Baseline up to treatment cessation or up to approximately 24 months)
- General Condition Status Using EuroQol Research Foundation EQ-5D-5L(Baseline up to treatment cessation or up to approximately 24 months)
- Treatment Satisfaction Using the Treatment Satisfaction Questionnaire for Medication (TSQM-9)(Baseline up to treatment cessation or up to approximately 24 months)
- Participant-reported PFS(Baseline up to disease progression or death due to any cause, whichever comes first (approximately 24 months))