RETROSPECTIVE CHART REVIEW STUDY OF FIRST LINE LORLATINIB IN LOCALLY ADVANCED/METASTATIC ALK-POSITIVE NON-SMALL CELL LUNG CANCER PATIENTS IN CHINA
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Pfizer
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Age at Start of Lorlatinib Treatment
研究概览
简要总结
The purpose of this retrospective study is to learn about the real-world effects of the study medicine lorlatinib for the first-line treatment of Chinese adult patients who were diagnosed with ALK-positive a/mNSCLC.
The participants included in this study are:
- Aged 18 years or more
- diagnosed with a/mNSCLC
- confirmed with testing for ALK-positive
- have started first-line lorlatinib treatment during the patient selection period
In this study, the main objectives are to learn the patient characteristics and the real-world treatment pattern of first-line treatment of lorlatinib in China at a real-world setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •to be eligible for inclusion in the study:
- •Age ≥18 years
- •Diagnosed with a/mNSCLC
- •Confirmed testing for ALK-positive
- •Initiated first-line lorlatinib treatment during the patient selection period, prior therapy such as adjuvant or neoadjuvant treatment are allowed.
- •A minimum lookback period of at least 3 months to establish a baseline period and ensure first-line use of cohort entry drug
- •Have at least 6 months of follow-up data available (early death or progression will be included)
排除标准
- 未提供
研究组 & 干预措施
Lorlatinib in locally advanced/metastatic ALK-positive Non-Small Cell Lung Cancer Patients in China
干预措施: Lorlatinib (Drug)
结局指标
主要结局
Age at Start of Lorlatinib Treatment
时间窗: At initiation of lorlatinib treatment between July 2022- October 2024
Number of percentages of patients by age
Smoking status (if available) at Start of Lorlatinib Treatment
时间窗: At initiation of lorlatinib treatment between July 2022- October 2024
Number of patients by smoking status
Histology of patients at start of Lorlatinib treatment
时间窗: At initiation of lorlatinib treatment between July 2022- October 2024
Histology of patients were reported in this outcome measure
Eastern Cooperative Oncology Group (ECOG) performance status of patients at Start of Lorlatinib Treatment
时间窗: At initiation of lorlatinib treatment between July 2022- October 2024
number of Eastern Cooperative Oncology Group (ECOG) performance status of patients
Initial cancer stage at diagnosis of patients prior Start of Lorlatinib Treatment
时间窗: At initiation of lorlatinib treatment between July 2022- October 2024
initial cancer stage of patients were reported in this outcome measure
Current cancer stage at Start of Lorlatinib Treatment
时间窗: At initiation of lorlatinib treatment between July 2022- October 2024
Current cancer stage of patients were reported in this outcome measure
Brain metastases status at Start of Lorlatinib Treatment
时间窗: At initiation of lorlatinib treatment between July 2022- October 2024
Brain metastases status of patients were reported in this outcome measure
Date of initial NSCLC diagnosis
时间窗: At initiation of lorlatinib treatment between July 2022- October 2024
Date of initial NSCLC diagnosis
Date of a/mNSCLC diagnosis
时间窗: At initiation of lorlatinib treatment between July 2022- October 2024
Date of a/mNSCLC diagnosis of patients were reported in this outcome measure
ALK-positive diagnosis prior to Start of Lorlatinib Treatment
时间窗: At initiation of lorlatinib treatment between July 2022- October 2024
Date of patients with ALK-positive diagnosis
Gene testing method and results prior to initiation of lorlatinib treatment
时间窗: At initiation of lorlatinib treatment between July 2022- October 2024
Gene testing method and results of patients were reported in this outcome measure
Date of brain metastases diagnosis prior to initiation of lorlatinib treatment
时间窗: At initiation of lorlatinib treatment between July 2022- October 2024
number and date of brain metastases diagnosis of patients for whom had BM prior lorlatinib treatment
Presence of comorbidities at Start of Lorlatinib Treatment
时间窗: At initiation of lorlatinib treatment between July 2022- October 2024
Presence of comorbidities of patients were reported in this outcome measure
Concomitant therapies at Start of Lorlatinib Treatment
时间窗: At initiation of lorlatinib treatment between July 2022- October 2024
Concomitant therapies of patients were reported in this outcome measure
Date of lorlatinib initiation
时间窗: At initiation of lorlatinib treatment between July 2022- October 2024
Date of Lorlatinib first prescription were reported in this outcome measure
Initial lorlatinib dose at Start of Lorlatinib Treatment
时间窗: At initiation of lorlatinib treatment between July 2022- October 2024
Initial lorlatinib dose for patients receiving Lorlatinb treatment were reported in this outcome measure
Dose adjustments when patients were prescribed with Lorlatinib Treatment
时间窗: From the date of initiation of lorlatinib treatment to the date of treatment dose adjustments, assessed up to 50 months (where 50 months is the estimated maximum follow-up duration for this outcome).
Dose adjustments of Lorlatinib Treatment and Date were reported in this outcome measure
Gender at Start of Lorlatinib Treatment
时间窗: At initiation of lorlatinib treatment between July 2022- October 2024
Number of patients by gender
Weight at Start of Lorlatinib Treatment
时间窗: At initiation of lorlatinib treatment between July 2022- October 2024
Number of patients by weight
Height at Start of Lorlatinib Treatment
时间窗: At initiation of lorlatinib treatment between July 2022- October 2024
Number of patients by height
Body mass index (BMI) at Start of Lorlatinib Treatment
时间窗: At initiation of lorlatinib treatment between July 2022- October 2024
Number of patients by BMI
次要结局
- Time to Discontinuation (TTD) in 1 L lorlatinib patients(From the date of first lorlatinib dose until permanent discontinuation of treatment for any cause, assessed up to 50 months (where 50 months is the estimated maximum follow-up duration for this outcome).)
- Last dose for Patients who are still on the Lorlatinib first line treatment(the date of any-cause treatment discontinuation or study end, assessed up to 50 months (where 50 months is the estimated maximum follow-up duration for this outcome).)
- Treatment switching to other ALK TKls from Lorlatinib Treatment(From the date of initiation of other ALK TKIs to the study end, assessed up to 50 months (where 50 months is the estimated maximum follow-up duration for this outcome).)
- Treatment switching to subsequence treatment from 1L Lorlatinib Treatment(From the date of initiation of subsequent other treatment to the date of any-cause treatment discontinuation or study end, assessed up to 50 months (where 50 months is the estimated maximum follow-up duration for this outcome).)
- Medical Costs during lorlatinib treatment period(From the date of first lorlatinib dose until permanent discontinuation of treatment for any cause, assessed up to 50 months (where 50 months is the estimated maximum follow-up duration for this outcome).)
- Brain metastases progression and date of patients receiving Lorlatinib treatment(From the date of initiation of lorlatinib treatment to the date of BM progression, assessed up to 50 months (where 50 months is the estimated maximum follow-up duration for this outcome).)
- Death (if applicable) of patients receiving Lorlatinib for the first-line treatment(From the date of initiation of lorlatinib treatment to the date of any-cause treatment discontinuation or study end, assessed up to 50 months (where 50 months is the estimated maximum follow-up duration for this outcome).)
- The cumulative incidence rate of BM of patients receiving Lorlatinib for the first-line treatment(From the date of initiation of lorlatinib treatment to the date of any-cause treatment discontinuation or study end, assessed up to 50 months (where 50 months is the estimated maximum follow-up duration for this outcome).)
- 1L lorlatinib resistance mechanism (if applicable)(From the date of initiation of lorlatinib treatment to the date of any-cause treatment discontinuation or study end, assessed up to 50 months (where 50 months is the estimated maximum follow-up duration for this outcome).)