Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lorlatinib in locally advanced/metastatic ALK-positive Non-Small Cell Lung Cancer Patients in China |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lorlatinib | Drug | for the treatment of patients with locally advanced or metastatic ALK positive non-small cell lung cancer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Age at Start of Lorlatinib Treatment | Number of percentages of patients by age | At initiation of lorlatinib treatment between July 2022- October 2024 |
| Smoking status (if available) at Start of Lorlatinib Treatment | Number of patients by smoking status | At initiation of lorlatinib treatment between July 2022- October 2024 |
| Histology of patients at start of Lorlatinib treatment | Histology of patients were reported in this outcome measure | At initiation of lorlatinib treatment between July 2022- October 2024 |
| Eastern Cooperative Oncology Group (ECOG) performance status of patients at Start of Lorlatinib Treatment | number of Eastern Cooperative Oncology Group (ECOG) performance status of patients | At initiation of lorlatinib treatment between July 2022- October 2024 |
| Initial cancer stage at diagnosis of patients prior Start of Lorlatinib Treatment | initial cancer stage of patients were reported in this outcome measure | At initiation of lorlatinib treatment between July 2022- October 2024 |
| Current cancer stage at Start of Lorlatinib Treatment | Current cancer stage of patients were reported in this outcome measure | At initiation of lorlatinib treatment between July 2022- October 2024 |
| Brain metastases status at Start of Lorlatinib Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Discontinuation (TTD) in 1 L lorlatinib patients | 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. | 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). |
Not provided
Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
Not provided
Not provided
Not provided
Chinese adult patients who were diagnosed with ALK-positive a/mNSCLC, and initiated lorlatinib as first line treatment
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer | Beijing | China |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000590786 | lorlatinib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Brain metastases status of patients were reported in this outcome measure
| At initiation of lorlatinib treatment between July 2022- October 2024 |
| Date of initial NSCLC diagnosis | Date of initial NSCLC diagnosis | At initiation of lorlatinib treatment between July 2022- October 2024 |
| Date of a/mNSCLC diagnosis | Date of a/mNSCLC diagnosis of patients were reported in this outcome measure | At initiation of lorlatinib treatment between July 2022- October 2024 |
| ALK-positive diagnosis prior to Start of Lorlatinib Treatment | Date of patients with ALK-positive diagnosis | At initiation of lorlatinib treatment between July 2022- October 2024 |
| Gene testing method and results prior to initiation of lorlatinib treatment | Gene testing method and results of patients were reported in this outcome measure | At initiation of lorlatinib treatment between July 2022- October 2024 |
| Date of brain metastases diagnosis prior to initiation of lorlatinib treatment | number and date of brain metastases diagnosis of patients for whom had BM prior lorlatinib treatment | At initiation of lorlatinib treatment between July 2022- October 2024 |
| Presence of comorbidities at Start of Lorlatinib Treatment | Presence of comorbidities of patients were reported in this outcome measure | At initiation of lorlatinib treatment between July 2022- October 2024 |
| Concomitant therapies at Start of Lorlatinib Treatment | Concomitant therapies of patients were reported in this outcome measure | At initiation of lorlatinib treatment between July 2022- October 2024 |
| Date of lorlatinib initiation | Date of Lorlatinib first prescription were reported in this outcome measure | At initiation of lorlatinib treatment between July 2022- October 2024 |
| Initial lorlatinib dose at Start of Lorlatinib Treatment | Initial lorlatinib dose for patients receiving Lorlatinb treatment were reported in this outcome measure | At initiation of lorlatinib treatment between July 2022- October 2024 |
| Dose adjustments when patients were prescribed with Lorlatinib Treatment | Dose adjustments of Lorlatinib Treatment and Date were reported in this outcome measure | 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). |
| Gender at Start of Lorlatinib Treatment | Number of patients by gender | At initiation of lorlatinib treatment between July 2022- October 2024 |
| Weight at Start of Lorlatinib Treatment | Number of patients by weight | At initiation of lorlatinib treatment between July 2022- October 2024 |
| Height at Start of Lorlatinib Treatment | Number of patients by height | At initiation of lorlatinib treatment between July 2022- October 2024 |
| Body mass index (BMI) at Start of Lorlatinib Treatment | Number of patients by BMI | At initiation of lorlatinib treatment between July 2022- October 2024 |
| Last dose for Patients who are still on the Lorlatinib first line treatment | Last dose for Patients who are still on the therapy were reported in this outcome measure | 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 | 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. | 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). |
| 1L lorlatinib resistance mechanism (if applicable) | 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. | 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). |
| Treatment switching to subsequence treatment from 1L Lorlatinib Treatment | 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. | 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 | Medical Costs during lorlatinib treatment period for patients were reported in this outcome measure, inducing drug costs, hospitalization costs, outpatient cost, and ect. | 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 | Brain metastases progression was radiological confirmation of new or worsening intracranial lesions. | 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 | percentage of Deaths (and date if applicable) of patients | 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 | Percentage of number of patients with BM | 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). |