Ignite Creation Date:
2024-05-06 @ 9:48 AM
Last Modification Date:
2024-10-26 @ 12:20 PM
Study NCT ID:
NCT03083041
Status:
COMPLETED
Last Update Posted:
2023-02-03
First Post:
2017-03-02
Brief Title:
A Study of SHR-1210 in Combination With Apatinib in Advanced Non-Small Cell Lung CancerNSCLC
Sponsor:
Jiangsu HengRui Medicine Co Ltd
Organization:
Jiangsu HengRui Medicine Co Ltd
Study Overview
Official Title:
A Phase II Study of SHR-1210 in Combination With Apatinib in Advanced Non-Small Cell Lung
Status:
COMPLETED
Status Verified Date:
2022-06
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 multi-center open-label Phase II study of intravenous IV SHR-1210 at 200mgq2w in combination with Apatinib at two dose levels in subjects with locally advanced or metastatic non-small cell lung cancer NSCLC
The study is composed of two parts Part 1 of the study will determine the safety tolerability and pharmacokinetics of SHR-1210 in combination with Apatinib
Part 2 includes a randomized comparison of Apatinib 250mgd or 500mgd plus SHR-1210
Subjects tumors will be screened at baseline for EGFR mutations EML4-ALK translocation and PD-L1 expressionBut positive tumor PD-L1 expression will not be required for enrollment
The study is composed of two parts Part 1 of the study will determine the safety tolerability and pharmacokinetics of SHR-1210 in combination with Apatinib
Part 2 includes a randomized comparison of Apatinib 250mgd or 500mgd plus SHR-1210
Subjects tumors will be screened at baseline for EGFR mutations EML4-ALK translocation and PD-L1 expressionBut positive tumor PD-L1 expression will not be required for enrollment
Detailed Description:
SHR-1210 is a humanized monoclonal antibody against Programmed death 1PD-1 Apatinib is a new kind of selective Vascular Endothelial Growth Factor Receptor 2VEGFR-2 tyrosine kinase inhibitor TKI A disease-control rate of 611 and a mPFS of 47 months were showed in Apatinib phase II study in patients with NSCLC
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