A Multicenter Prospective Cohort Study of the Patient-Reported Outcomes in ALK Positive Advanced Non-Small Cell Lung Cancer (NSCLC) in China
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 800
- 主要终点
- EORTC QLQ-LC13
研究概览
简要总结
This is a multicenter, prospective, longitudinal observational study designed to evaluate the patient-reported outcomes and safety profiles of patients with ALK positive advanced Non-Small Cell Lung Cancer (NSCLC) who received ALK-TKIs as first-line treatment.
Approximately 800 patients with ALK-positive locally advanced or metastatic NSCLC will be enrolled in this study. This study has 3 parallel cohorts which are listed below.
Patient-reported outcome data will be collected using the following instruments: EORTC QLQ-C30, EORTC QLQ-LC13, selected items from the PRO-CTCAE, EORTC-IL46.
详细描述
A total of 800 patients with ALK+ NSCLC will be enrolled in this study. The actual number of sites can be increased or decreased as appropriate. In order to approach the real world medication situation, the number of patients treated with Alectinib will be 400 cases; the number of patients treated with Lorlatinib will be 200 cases; the number of patients treated with the other ALK-TKIs will be 200 cases in total.
Study Population The study population is intended to follow the real-world use of ALK-TKIs treatment; therefore, minimal inclusion and exclusion criteria will be used. The study population will comprise patients treated with ALK-TKIs for ALK-positive advanced NSCLC.
Patients in all 3 cohorts who meet any of the following criteria will be excluded from study entry:
- Patients receiving ALK-TKIs as investigational study drugs in a clinical trial for the treatment of advanced NSCLC
- Patients participating in clinical trials within 28 days prior to initiation of study treatment
- Pregnant, lactating, or breastfeeding women Statistical Methods Primary Analysis The primary objective for this study is to describe the patient-reported outcomes in patients with ALK+ locally advanced or metastatic NSCLC who received ALK-TKIs as first-line treatment in the real world situation. Analyses were conducted using the full analysis set (FAS), which comprised all 3 cohorts of patients enrolled in the study population with at least baseline data in eCRFs. The PRO analysis set consists of all patients in the FAS who completed at least one baseline questionnaire and at least one post baseline questionnaire.Patients with no post-baseline information will be censored at the date of enrollment.
Proportion of patients reporting clinically meaningful deterioration (decrease from baseline of ≥ 10 points) in the subscales of EORTC QLQ-LC13 (fatigue, chest pain) and QLQ-C30 (cognitive, physical and role functioning) will be summarized.
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
- •Have signed the informed consent form (ICF) as per local regulations
- •Female or male aged 18 years or older
- •Ability to comply with the study protocol, in the judgment of the investigator
- •Life expectancy ≥ 12 weeks
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0, 1, or 2
- •Have a confirmed diagnosis of locally advanced or metastatic NSCLC on or after the date of local approval for ALK-TKIs as first-line monotherapy regimen 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 determined by Ventana immunohistochemistry (IHC), fluorescent in situ hybridization (FISH), reverse transcription polymerase chain reaction(RT-PCR) and next generation sequencing (NGS), documented prior to receiving treatment with an ALK inhibitor
- •Planned to receive, treatment for ALK-positive advanced NSCLC with ALK-TKIs
- •Able to be followed up at the participating site
- •Patients with advanced NSCLC who have asymptomatic central nervous system (CNS) metastases are eligible for inclusion
排除标准
- •Patients receiving ALK-TKIs as investigational study drugs in a clinical trial for the treatment of advanced NSCLC
- •Patients participating in clinical trials within 28 days prior to initiation of study treatment
- •Pregnant, lactating, or breastfeeding women
结局指标
主要结局
EORTC QLQ-LC13
时间窗: The data collection period for an individual patient was approximately 12 months, which could be truncated by treatment switching, patient withdrawal from the study, or death.
Proportion of patients reporting clinically meaningful deterioration (decrease from baseline of ≥10 points) in the subscales of EORTC QLQ-LC13 (fatigue, chest pain) ;Change from baseline score (by 2 cycles) in the subscales of EORTC QLQ-LC13 (fatigue, chest pain) .
EORTC QLQ-C30
时间窗: The data collection period for an individual patient was approximately 12 months, which could be truncated by treatment switching, patient withdrawal from the study, or death.
Proportion of patients reporting clinically meaningful deterioration (decrease from baseline of ≥ 10 points) in the subscales of QLQ-C30 (cognitive, physical and role functioning);Change from baseline score (by 2 cycles) in the subscales of QLQ-C30 (cognitive, physical and role functioning).
NCI PRO-CTCAE
时间窗: The data collection period for an individual patient was approximately 12 months, which could be truncated by treatment switching, patient withdrawal from the study, or death.
Presence, frequency of occurrence, severity, and/or degree of interference with daily function of symptomatic treatment toxicities (swelling, rash, blurred vision, anxious, sad) as assessed through use of the NCI PRO-CTCAE.
EORTC Item List (IL46)
时间窗: The data collection period for an individual patient was approximately 12 months, which could be truncated by treatment switching, patient withdrawal from the study, or death.
Frequency of patients\' response of the degree they are troubled with treatment symptoms, as assessed through use of the Protocol ML44840, Version 2.0 single-item EORTC Item List (IL46)
次要结局
- To evaluate the safety of ALK-TKIs as first-line treatment in advanced ALK+ NSCLC(The data collection period for an individual patient was approximately 12 months, which could be truncated by treatment switching, patient withdrawal from the study, or death.)
- To evaluate the tolerability of ALK-TKIs as first-line treatment in advanced ALK+ NSCLC(The data collection period for an individual patient was approximately 12 months, which could be truncated by treatment switching, patient withdrawal from the study, or death.)