Non-Small Cell Lung Cancer ALK-positive
Conditions
Brief 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.
Interventions
DRUGLorlatinib
for the treatment of patients with locally advanced or metastatic ALK positive non-small cell lung cancer.
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). | Time to Discontinuation (TTD) was the time from the date of initiation of Lorlatinib Treatment to date if the permanent cessation of lorlatinib due to any reasons, including progression, adverse events, patient decision, or physician recommendation. TTD will be analyzed using Kaplan-Meier survival analysis. |
| 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). | Last dose for Patients who are still on the therapy were reported in this outcome measure |
| 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 other ALK TKls was switching from lorlatinib to another ALK-TKIs due to any reasons. The Name of treatment regimen, Date of treatment switch and Duration of each switched regimen were recorded in this outcome measure. |
| 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). | Characterization of acquired resistance mechanisms to first-line lorlatinib, including on-target ALK alterations and off-target/bypass pathway activations, as identified at disease progression. |
| 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). | Treatment switching to subsequence treatment was switching from lorlatinib to another systemic therapy due to treatment failure caused by progression, intolerance, or physician decision. It was recorded in this outcome measure. |
| 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). | Medical Costs during lorlatinib treatment period for patients were reported in this outcome measure, inducing drug costs, hospitalization costs, outpatient cost, and ect. |
| 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). | Brain metastases progression was radiological confirmation of new or worsening intracranial lesions. |
| 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). | percentage of Deaths (and date if applicable) of patients |
| 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). | Percentage of number of patients with BM |
Countries
China
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed