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| ID | Type | Description | Link |
|---|---|---|---|
| NCT06678555 | Registry Identifier | ClinicalTrials.gov |
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The purpose of this study is to learn about lorlatinib for the possible treatment of lung cancer which could not be controlled.
This study is seeking participants who:
All participants in this study had received lorlatinib. Lorlatinib is a tablet that is taken by mouth at home. They continued to take lorlatinib until their cancer was no longer responding. The study will look at the experiences of people receiving the study medicine. This will help to see if the study medicine is safe and effective.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lorlatinib | Patients with ROS1(+) advanced/metastatic NSCLC had been treated with lorlatinib. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lorlatinib | Drug | Lorlatinib is an ALK/ROS1 tyrosin kinase inhibitor. |
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| Measure | Description | Time Frame |
|---|---|---|
| real-world progression-free survival | Time to real-world disease progression or death, whichever occurs first, during observation period from index date will be summarized by the K-M plot with the corresponding 95% CI. Index date is the date of the first dose of lorlatinib. | 74 months from 1st April, 2018 |
| The overall survival (OS) | Time to death during observation period from index date will be summarized by the K-M plot with the corresponding 95% CI. Index date is the date of the first dose of lorlatinib. | 74 months from 1st April, 2018 |
| The real world time to next treatment (rwTTNT) | Time to subsequent treatment or death, whichever occurs first, during observation period from index date will be summarized by the K-M plot with the corresponding 95% CI. Index date is the date of the first dose of lorlatinib. | 74 months from 1st April, 2018 |
| The real world intracranial progression free survival (rwICPFS) | Time to real-world intracranial disease progression or death, whichever occurs first, during observation period from index date will be summarized by the K-M plot with the corresponding 95% CI. Index date is the date of the first dose of lorlatinib. | 74 months from 1st April, 2018 |
| Measure | Description | Time Frame |
|---|---|---|
| Number and proportion of patients receiving each regimen of systemic anti-cancer therapy | The percentage of patients with each systemic anticancer therapy for lung cancer. | 74 months from 1st April, 2018 |
| Mean (SD), median (interquartile range, IQR), minimum and maximum value of duration of therapy (DoT) of lorlatinib |
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Inclusion Criteria:
Exclusion Criteria:
1. Patients participated in any clinical trials using lorlatinib during the observation period.
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This is a retrospective, observational study to investigate effectiveness, treatment patterns, and gene mutation profile of ROS1-positive NSCLC patients who had received lorlatinib after any TKI treatment failure in Taiwan using an EMR database, NTUH-iMD. Study population consists of patients who were diagnosed with ROS1-positive NSCLC and received at least one dose of lorlatinib between 1st April, 2018, and 30th September, 2023 after any TKI treatment failure.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer | Taipei | Taiwan |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C000590786 | lorlatinib |
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Time to real-world discontinuation of lorlatinib or death, whichever occurs first, during observation period from index date will be summarized by the K-M plot with the corresponding 95% CI. Index date is the date of the first dose of lorlatinib. |
| 74 months from 1st April, 2018 |
| Number and proportion of patients receiving concomitant antihyperlipidemic agents | The number and percentage of patients receiving antihyperlipidemic agents received along with lorlatinib during the same treatment period | 74 months from index date; index date is the date of the first dose of lorlatinib |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |