Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06348199
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-03-28
Brief Title:
A Study to Compare the Efficacy Safety Pharmacokinetics and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer
Sponsor:
Samsung Bioepis Co Ltd
Organization:
Samsung Bioepis Co Ltd
Study Overview
Official Title:
A Phase III Randomised Double-blind Multicentre Study to Compare the Efficacy Safety Pharmacokinetics and Immunogenicity Between SB27 Proposed Pembrolizumab Biosimilar and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer
Status:
RECRUITING
Status Verified Date:
2024-10
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:
The goal of this clinical trial is to confirm that SB27 works in the same way as Keytruda in metastatic non-squamous non-small cell lung cancer NSCLC patients The main question it aims to answer is
How effective the study drug is Participants will receive either investigational product SB27 or Keytruda and chemotherapy every 3 weeks
Researchers will compare SB27 and Keytruda to see if SB27 works in the same way as Keytruda
How effective the study drug is Participants will receive either investigational product SB27 or Keytruda and chemotherapy every 3 weeks
Researchers will compare SB27 and Keytruda to see if SB27 works in the same way as Keytruda
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