Ignite Creation Date:
2024-05-06 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 2:20 PM
Study NCT ID:
NCT05167500
Status:
COMPLETED
Last Update Posted:
2023-03-30
First Post:
2021-11-09
Brief Title:
Efficacy Safety Study of Lorlatinib in ALKROS1 Metastatic NSCLC Patients With Compassionate Use Treatment
Sponsor:
Fundación GECP
Organization:
Fundación GECP
Study Overview
Official Title:
Retrospective Observational Study On The Efficacy And Safety Of Lorlatinib In ALK or ROS1 Metastatic Non-Small Cell Lung Cancer Patients Treated Within The Compassionate Use Program In Spain
Status:
COMPLETED
Status Verified Date:
2023-03
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:
LORLAPULM
Brief Summary:
This is an observational non-interventional retrospective multicentre and nationwide study The information will be obtained retrospectively in most cases when the treatment has already ended
The primary objective of this study is determine the activity of lorlatinib percentage of responses duration of response progression-free survival and time to treatment failure of patients included in the compassionate use program in Spain
The primary objective of this study is determine the activity of lorlatinib percentage of responses duration of response progression-free survival and time to treatment failure of patients included in the compassionate use program in Spain
Detailed Description:
This is an observational non-interventional retrospective multicentre and nationwide study The information will be obtained retrospectively in most cases when the treatment has already ended In cases where the patient continues on the treatment the researcher will not modify the clinical management of the patient by participating in the study
Patients with metastatic non-small cell lung cancer treated with lorlatinib who were included in the compassionate use program in Spain between November 2016 and February 2019 for those with an ALK alteration and between November 2016 to March 2021 for those with ROS1 alteration According to the records of the Spanish centres participating in this program approximately 145 patients have been included
The primary objective of this study is determine the activity of lorlatinib percentage of responses duration of response progression-free survival and time to treatment failure of patients included in the compassionate use program in Spain
Patients with metastatic non-small cell lung cancer treated with lorlatinib who were included in the compassionate use program in Spain between November 2016 and February 2019 for those with an ALK alteration and between November 2016 to March 2021 for those with ROS1 alteration According to the records of the Spanish centres participating in this program approximately 145 patients have been included
The primary objective of this study is determine the activity of lorlatinib percentage of responses duration of response progression-free survival and time to treatment failure of patients included in the compassionate use program in Spain
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