Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06410040
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-05-05
Brief Title:
A Retrospective Study of the Efficacy and Safety of Lolatinib in ALK NSCLC Patients With Brain or Meningeal Metastasis
Sponsor:
Sichuan Cancer Hospital and Research Institute
Organization:
Sichuan Cancer Hospital and Research Institute
Study Overview
Official Title:
A Retrospective Study of the Efficacy and Safety of Lolatinib in Anaplastic Lymphoma Kinase ALK - Positive Non-Small Cell Lung Cancer NSCLC Patients With Brain or Meningeal Metastasis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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 retrospective observational study The study included patients with non-small cell lung cancer with ALK-fusion brain metastases or meningeal metastases who received first-line and late-line treatment with the third-generation ALK TKI lorlatinib between June 2022 and June 2023
Data were collected from the electronic medical records database and hospital information system of many hospitals in Sichuan Province Clinical pathology features including gender age ALK mutation status at diagnosis and clinical stage at diagnosis were collected from the medical records The physical condition assessed by ECOG-PS before the administration of lorlatinib was recorded Information on anti-tumor therapy was obtained from the records including dose and time of ALK-TKI therapy and tumor response number of prior systemic therapy lines drug regimen efficacy and whether local therapy such as radiotherapy and surgery had been received In this study the sample size is not limited and information is collected according to the maximum number of patients The study period was from 01 July 2023 to 30 June 2024
Data were collected from the electronic medical records database and hospital information system of many hospitals in Sichuan Province Clinical pathology features including gender age ALK mutation status at diagnosis and clinical stage at diagnosis were collected from the medical records The physical condition assessed by ECOG-PS before the administration of lorlatinib was recorded Information on anti-tumor therapy was obtained from the records including dose and time of ALK-TKI therapy and tumor response number of prior systemic therapy lines drug regimen efficacy and whether local therapy such as radiotherapy and surgery had been received In this study the sample size is not limited and information is collected according to the maximum number of patients The study period was from 01 July 2023 to 30 June 2024
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