Ignite Creation Date:
2024-05-06 @ 4:25 PM
Last Modification Date:
2024-10-26 @ 2:10 PM
Study NCT ID:
NCT04979988
Status:
COMPLETED
Last Update Posted:
2024-04-05
First Post:
2021-07-19
Brief Title:
Study to Evaluate Clinical Real World Outcomes of Lorlatinib After Alectinib in ALK-Positive NSCLC Japanese Patients
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
Retrospective Multicenter Observational Study to Evaluate Clinical Real World Outcomes of Lorlatinib After Alectinib in ALK-Positive NSCLC Japanese Patients
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the clinical real world outcomes of lorlatinib in secondlater line setting anaplastic lymphoma kinase ALK tyrosine kinase inhibitor TKI to TKI sequence sequence treatment after failure of alectinib as a first-line treatment in Japanese ALK positive non-small cell lung cancer NSCLC
Detailed Description:
This study is a post-approval company-sponsored observational study This study is a multicenter non-interventional retrospective chart review of patients with ALK NSCLC patients treated using lorlatinib as the secondlater line therapy in Japan after failure of alectinib treatment as the first line therapy from 20 November 2018
All decisions regarding clinical management and treatment of the participating patients were made by an investigator as part of standard care in real-world clinical setting and were not contingent upon the patients participation in the study Data will be collected if available per study site Patients in this study are those who started treatment with lorlatinib from 1 May 2019 to 31 December 2020 in clinical practice
All decisions regarding clinical management and treatment of the participating patients were made by an investigator as part of standard care in real-world clinical setting and were not contingent upon the patients participation in the study Data will be collected if available per study site Patients in this study are those who started treatment with lorlatinib from 1 May 2019 to 31 December 2020 in clinical practice
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None