Ignite Creation Date:
2024-05-06 @ 3:06 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04524689
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2020-08-20
Brief Title:
Tusamitamab Ravtansine SAR408701 in Combination With Pembrolizumab and Tusamitamab Ravtansine SAR408701 in Combination With Pembrolizumab and Platinum-based Chemotherapy With or Without Pemetrexed in Patients With NSQ NSCLC
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Open-label Phase 2 Study of Tusamitamab Ravtansine SAR408701 Combined With Pembrolizumab and Tusamitamab Ravtansine SAR408701 Combined With Pembrolizumab and Platinum-based Chemotherapy With or Without Pemetrexed in Patients With CEACAM5 Positive Expression AdvancedMetastatic Non-squamous Non-small-cell Lung Cancer NSQ NSCLC
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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:
CARMEN-LC05
Brief Summary:
Primary Objective
Safety run-in part to assess the tolerability and to determine the recommended doses of tusamitamab ravtansine in combination with pembrolizumab and tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy with or without pemetrexed to be tested in the expansion part of the study in the NSQ NSCLC population
Expansion part including participants treated at the recommended dose for expansion RDE from the Safety Run-in part to assess the antitumor activity of several dose levels DLs if applicable of tusamitamab ravtansine in combination with pembrolizumab and of several DLs of tusamitamab ravtansine in combination with pembrolizumab platinum-based chemotherapy and pemetrexed in the NSQ NSCLC population
Secondary Objectives
To assess the safety and tolerability of several DLs if applicable of tusamitamab ravtansine in combination with pembrolizumab and of 1 DL of tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy and of several DLs of tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy with pemetrexed in the NSQ NSCLC population
To assess the antitumor activity of several DLs if applicable of tusamitamab ravtansine in combination with pembrolizumab and of 1 DL of tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy and of several DLs of tusamitamab ravtansine in combination with pembrolizumab platinum-based chemotherapy and pemetrexed in the NSQ NSCLC population
To assess the durability of the response to treatment with several DLs if applicable of tusamitamab ravtansine in combination with pembrolizumab and of 1 DL of tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy and of several DLs of tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy and pemetrexed in the NSQ NSCLC population
To assess the antitumor activity of tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy in the NSQ NSCLC population
To assess the pharmacokinetics PK of tusamitamab ravtansine pembrolizumab pemetrexed cisplatin and carboplatin each when given in combination as a doublet tusamitamab ravtansine pembrolizumab or a triplet tusamitamab ravtansine pembrolizumab platinum-based chemotherapy or a quadruplet tusamitamab ravtansine pembrolizumab platinum-based chemotherapy pemetrexed
To assess the immunogenicity of tusamitamab ravtansine in combination with pembrolizumab and tusamitamab ravtansine in combination with pembrolizumab and platinum based chemotherapy with or without pemetrexed
Safety run-in part to assess the tolerability and to determine the recommended doses of tusamitamab ravtansine in combination with pembrolizumab and tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy with or without pemetrexed to be tested in the expansion part of the study in the NSQ NSCLC population
Expansion part including participants treated at the recommended dose for expansion RDE from the Safety Run-in part to assess the antitumor activity of several dose levels DLs if applicable of tusamitamab ravtansine in combination with pembrolizumab and of several DLs of tusamitamab ravtansine in combination with pembrolizumab platinum-based chemotherapy and pemetrexed in the NSQ NSCLC population
Secondary Objectives
To assess the safety and tolerability of several DLs if applicable of tusamitamab ravtansine in combination with pembrolizumab and of 1 DL of tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy and of several DLs of tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy with pemetrexed in the NSQ NSCLC population
To assess the antitumor activity of several DLs if applicable of tusamitamab ravtansine in combination with pembrolizumab and of 1 DL of tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy and of several DLs of tusamitamab ravtansine in combination with pembrolizumab platinum-based chemotherapy and pemetrexed in the NSQ NSCLC population
To assess the durability of the response to treatment with several DLs if applicable of tusamitamab ravtansine in combination with pembrolizumab and of 1 DL of tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy and of several DLs of tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy and pemetrexed in the NSQ NSCLC population
To assess the antitumor activity of tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy in the NSQ NSCLC population
To assess the pharmacokinetics PK of tusamitamab ravtansine pembrolizumab pemetrexed cisplatin and carboplatin each when given in combination as a doublet tusamitamab ravtansine pembrolizumab or a triplet tusamitamab ravtansine pembrolizumab platinum-based chemotherapy or a quadruplet tusamitamab ravtansine pembrolizumab platinum-based chemotherapy pemetrexed
To assess the immunogenicity of tusamitamab ravtansine in combination with pembrolizumab and tusamitamab ravtansine in combination with pembrolizumab and platinum based chemotherapy with or without pemetrexed
Detailed Description:
The expected duration of study intervention for participants may vary based on disease progression date median expected duration of study per participant is estimated at 10 months up to 1 month for screening a median of 6 months for treatment a median of 1 month for EOT and follow-up visit 90 days after the last IMP administration
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 |
|---|---|---|---|
| 2023-509115-84 | REGISTRY | CTIS | None |
| U1111-1233-9798 | REGISTRY | None | None |