Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06282874
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-28
First Post:
2024-01-30
Brief Title:
Lorlatinib in Patients With ALK-Positive NSCLC With Brain or Leptomeningeal Metastases
Sponsor:
Guangdong Association of Clinical Trials
Organization:
Guangdong Association of Clinical Trials
Study Overview
Official Title:
An Open-label Single-arm Multicenter Prospective Study of Lorlatinib in Patients With ALK-Positive NSCLC With Brain or Leptomeningeal Metastases
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
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 is an investigator-initiated prospective open-label single-arm multicenter clinical trial aimed at exploring the antitumor activity of Lorlatinib in ALK-positive NSCLC patients with brain leptomeningeal metastases
Detailed Description:
Fifty eligible subjects will be divided into a BM cohort brain parenchymal metastasis only and an LM cohort leptomeningeal metastasis brain parenchymal metastasis All subjects will receive Lorlatinib 100 mg once daily on days 1 to 28 of each 28-day cycle
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?:
False
Is an FDA AA801 Violation?:
None