Ignite Creation Date:
2024-05-06 @ 2:36 PM
Last Modification Date:
2024-10-26 @ 1:33 PM
Study NCT ID:
NCT04362072
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2020-04-22
Brief Title:
Study of Lorlatinib In People With ALK-positive Non-small Cell Lung Cancer
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
Single-Arm Study of Lorlatinib in Participants With Anaplastic Lymphoma Kinase ALK-Positive Non-Small Cell Lung Cancer NSCLC Whose Disease Progressed After One Prior Second-Generation ALK Tyrosine Kinase Inhibitor TKI
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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:
The purpose of this clinical trial is to learn whether the study medicine called lorlatinib is safe and effective for the treatment of non-small cell lung cancer that is caused by an abnormal anaplastic lymphoma kinase ALK gene
This study is seeking participants whose lung cancer has progressed after receiving either alectinib or ceritinib as their first treatment
Participants will take part in this study for up to approximately 4 years depending on when the study is completed and how their cancer responds to the study treatment They will take lorlatinib orally by mouth once daily
Participants will visit the study site about every six weeks to meet with the study team During these visits the study team will monitor the safety and effects of lorlatinib
This study is seeking participants whose lung cancer has progressed after receiving either alectinib or ceritinib as their first treatment
Participants will take part in this study for up to approximately 4 years depending on when the study is completed and how their cancer responds to the study treatment They will take lorlatinib orally by mouth once daily
Participants will visit the study site about every six weeks to meet with the study team During these visits the study team will monitor the safety and effects of lorlatinib
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-002504-41 | EUDRACT_NUMBER | None | None |