Lorlatinib: for the treatment of patients with locally advanced or metastatic ALK positive non-small cell lung cancer.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
1. Age ≥18 years
2. Diagnosed with a/mNSCLC
3. Confirmed testing for ALK-positive
4. Initiated first-line lorlatinib treatment during the patient selection period, prior therapy such as adjuvant or neoadjuvant treatment are allowed.
5. A minimum lookback period of at least 3 months to establish a baseline period and ensure first-line use of cohort entry drug
6. Have at least 6 months of follow-up data available (early death or progression will be included)
Primary outcome measure(s)
Age at Start of Lorlatinib Treatment — 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 — At initiation of lorlatinib treatment between July 2022- October 2024 Number of patients by smoking status
Histology of patients at start of Lorlatinib treatment — 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 — 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 — 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 — 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 — 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 — At initiation of lorlatinib treatment between July 2022- October 2024 Date of initial NSCLC diagnosis
Date of a/mNSCLC diagnosis — 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 — 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 — 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 — 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 — 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 — At initiation of lorlatinib treatment between July 2022- October 2024 Concomitant therapies of patients were reported in this outcome measure
Date of lorlatinib initiation — 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 — 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 — 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 — At initiation of lorlatinib treatment between July 2022- October 2024 Number of patients by gender
Weight at Start of Lorlatinib Treatment — At initiation of lorlatinib treatment between July 2022- October 2024 Number of patients by weight
Height at Start of Lorlatinib Treatment — At initiation of lorlatinib treatment between July 2022- October 2024 Number of patients by height
Body mass index (BMI) at Start of Lorlatinib Treatment — At initiation of lorlatinib treatment between July 2022- October 2024 Number of patients by BMI
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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