Ignite Creation Date:
2024-05-06 @ 11:01 AM
Last Modification Date:
2024-10-26 @ 12:38 PM
Study NCT ID:
NCT03409614
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-25
First Post:
2018-01-10
Brief Title:
Combinations of Cemiplimab Anti-PD-1 Antibody and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer
Sponsor:
Regeneron Pharmaceuticals
Organization:
Regeneron Pharmaceuticals
Study Overview
Official Title:
A Two-Part Randomized Phase 3 Study of Combinations of Cemiplimab Anti-PD-1 Antibody and Platinum-based Doublet Chemotherapy in First-line Treatment of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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 primary objectives of this study are
Part 1 To compare the overall survival OS of cemiplimabchemo-f and cemiplimabchemo-lipi versus platinum-based doublet chemotherapy in the first-line treatment of patients with advanced squamous or nonsquamous non-small cell lung cancer NSCLC with tumors expressing PD-L1 in 50 of tumor cells
Part 2 To compare the OS of cemiplimabchemo-f with placebochemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC irrespective of PD-L1 expression
The key secondary objectives are
Part 1 To compare the progression-free survival PFS and objective response rate ORR of cemiplimabchemo-f and cemiplimabchemo-lipi versus chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC and tumors expressing PD-L1 in 50 of tumor cells
Part 2 To compare the PFS and ORR of cemiplimabchemo-f versus placebochemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC irrespective of PD-L1 expression
Part 1 To compare the overall survival OS of cemiplimabchemo-f and cemiplimabchemo-lipi versus platinum-based doublet chemotherapy in the first-line treatment of patients with advanced squamous or nonsquamous non-small cell lung cancer NSCLC with tumors expressing PD-L1 in 50 of tumor cells
Part 2 To compare the OS of cemiplimabchemo-f with placebochemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC irrespective of PD-L1 expression
The key secondary objectives are
Part 1 To compare the progression-free survival PFS and objective response rate ORR of cemiplimabchemo-f and cemiplimabchemo-lipi versus chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC and tumors expressing PD-L1 in 50 of tumor cells
Part 2 To compare the PFS and ORR of cemiplimabchemo-f versus placebochemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC irrespective of PD-L1 expression
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-001311-36 | EUDRACT_NUMBER | None | None |