Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04507217
Status:
COMPLETED
Last Update Posted:
2023-05-25
First Post:
2020-08-06
Brief Title:
Tislelizumab Combined With Pemetrexed Carboplatin in Patients With Brain Metastases of Non-squamous NSCLC
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
A Phase II Open-Label Multicenter Prospective Clinical Study to Investigate the Efficacy and Safety of Tislelizumab Combined With Pemetrexed Carboplatin in Patients With Brain Metastases of Non-squamous Non-small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2023-05
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 is a phase II Open-Label Multicenter Prospective Clinical Study to Investigate the Efficacy and Safety of Tislelizumab Combined with Pemetrexed Carboplatin in Patients with Brain Metastases of Non-squamous Non-small Cell Lung Cancer The primary end point is PFS and secondary endpoint is ORR OS DoR and Neurocognitive impairment during the study the exploratory objectives including 1 PD-L1 expression TMB and other potential predictive biomarkers correlated with response to treatment 2 Progression-free survival based on intracranial response iPFS according to RECIST 11 and RANO-BM
Detailed Description:
None
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