Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06361589
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-03-26
Brief Title:
Real World Study of Lolatinib for Advanced ALK NSCLC Patients
Sponsor:
Sichuan Cancer Hospital and Research Institute
Organization:
Sichuan Cancer Hospital and Research Institute
Study Overview
Official Title:
Real World Study of Lolatinib for Patients With AdvancedMetastatic Anaplastic Lymphoma Kinase ALK - Positive Non-Small Cell Lung Cancer NSCLC
Status:
RECRUITING
Status Verified Date:
2024-04
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:
This study was a multicenter prospective non-interventional clinical study that included first-line and late-line patients with advanced non-small cell lung cancer with ALK fusions treated with the third generation ALK-TKI lorlatinib until disease progression intolerable toxicity investigator or subject decision to withdraw lost to follow-up initiation of other antineoplastic therapy or death Clinical pathology including sex age ALK mutation status at diagnosis and clinical stage at diagnosis were collected from medical records Physical condition as assessed by ECOG-PS before administration of lorlatinib was also recorded Treatment information was obtained from the records including dose and timing of ALK-TKI therapy and tumor response number of prior systemic lines of therapy and local treatment modalities such as radiotherapy and surgery Quality of life based on the EORTC QLQ C30LC29 scale plus the EORTC QLQ BN20 scale in patients with brainmeningeal metastases was performed at baseline and at each follow-up point This study will use REDCap platform to collect and manage the study data information of multi-center patients
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?:
False
Is an FDA AA801 Violation?:
None