Ignite Creation Date:
2024-05-06 @ 2:06 PM
Last Modification Date:
2024-10-26 @ 1:25 PM
Study NCT ID:
NCT04211090
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-11-16
First Post:
2019-12-22
Brief Title:
Camrelizumab With AC in Patients With Brain Metastases of Driven Gene-negativeNSCLC
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
A Phase II Study to Evaluate Camrelizumab With Pemetrexed Carboplatin in Patients With Brain Metastases of Driven Gene-negative Non-squamous Non-small Cell Lung Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2022-11
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:
CAP-BRAIN
Brief Summary:
The primary hypothesis is that camrelizumab in combination with pemetrexed carboplatin will present a better efficacy for treatment of first line metastatic non-squamous non-small cell lung cancer and minimize the risk of toxicity
Detailed Description:
This is a prospective open-label phase Ⅱ studyto evaluate the efficacy and safetyof camrelizumab combined with pemetrexed carboplatin in participants with brain metastases ofnon-squamous non-small cell lung cancerPaticipant was confirmed without EGFR activating mutation or ALK fusion and received no prior systemic therapyPatients would receive camrelizumab in combination with pemetrexed carboplatin for 4 cyclesfollowed by camrelizumab and pemetrexed as maitenance treatment until progression camrelizumab will be administered no more than 24 months PD-L1 expression assessed with 22C3 pharmDx assay will be used as a stratification factor
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