Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06162572
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2023-11-29
Brief Title:
Phase 1b2 Platform Study of Select Immunotherapy Combinations in Participants With Advanced Non-small Cell Lung Cancer NSCLC
Sponsor:
Servier Bio-Innovation LLC
Organization:
Servier
Study Overview
Official Title:
A Phase 1b2 Multicenter Open-label Platform Study of Select Immunotherapy Combinations in Adult Participants With Previously Untreated Advanced Non-small Cell Lung Cancer NSCLC With High PD-L1 Expression
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:
This is a Phase 1b2 study evaluating the anti-PD1 antibody cemiplimab in combination with either S095018 anti-TIM3 antibody S095024 anti-CD73 antibody or S095029 anti-NKG2A antibody in adult participants with previously untreated advancedmetastatic non-small cell lung cancer NSCLC with high PD-L1 expression The study includes two parts part A the combination-therapy safety lead-in phase to determine the recommended dose for expansion RDE for S095018 S095024 and S095029 in combination with cemiplimab and part B the randomized dose expansion phase to assess the efficacy of S095018 S095024 or S095029 in combination with cemiplimab Study treatment will be administered for a maximum of 108 weeks or until confirmed disease progression per iRECIST and or until meeting other treatment discontinuation criteria
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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