Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-27 @ 11:46 PM
Study NCT ID:
NCT05704634
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-27
First Post:
2023-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase Ib Study to Evaluate the Safety and Preliminary Efficacy of IL6-receptor Antibody Sarilumab in Combination With antiPD1 Antibody Cemiplimab for Patients With Non-small Cell Lung Cancer.
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
A Phase Ib Study to Evaluate the Safety and Preliminary Efficacy of IL6-receptor Antibody Sarilumab in Combination With antiPD1 Antibody Cemiplimab for Patients With Non-small Cell Lung Cancer.
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To learn if the combination of sarilumab (also called Kevzara) and cemiplimab can help to control EGFR- or LKB1/STK11-mutant NSCLC.
Detailed Description:
Primary Objective:
* To evaluate the safety of sarilumab cemiplimab combination in metastatic lung cancer patients.
* The primary endpoint is DLT for safety Run-In cohort.
* To preliminarily assess efficacy of sarilumab cemiplimab combination in patients with EGFR- or LKB1/STK11-mutant NSCLC respectively.
* The primary efficacy endpoint is objective response rate (ORR) in cohort A and cohort B, evaluated separately.
Secondary Objectives:
--To evaluate the progression-free survival (PFS), disease control rate (DOR), duration of response (DoR), overall survival (OS), and safety and tolerability of this combination in patients with EGFR- or LKB1-mutant NSCLC respectively.
Correlative/Exploratory Objectives:
* Explore the association of baseline genomic profiles (from tumor, germline DNA, and ctDNA) with clinical benefit in patients treated with sarilumab and cemiplimab combination
* Explore the association of immune profiles (tumor immune microenvironment features) with clinical benefit in patients treated with sarilumab and cemiplimab combination
* Explore resistance mechanisms to sarilumab and cemiplimab combination.
* Determine the impact of sarilumab on immunotherapy-related side effects from cemiplimab.
* To evaluate the safety of sarilumab cemiplimab combination in metastatic lung cancer patients.
* The primary endpoint is DLT for safety Run-In cohort.
* To preliminarily assess efficacy of sarilumab cemiplimab combination in patients with EGFR- or LKB1/STK11-mutant NSCLC respectively.
* The primary efficacy endpoint is objective response rate (ORR) in cohort A and cohort B, evaluated separately.
Secondary Objectives:
--To evaluate the progression-free survival (PFS), disease control rate (DOR), duration of response (DoR), overall survival (OS), and safety and tolerability of this combination in patients with EGFR- or LKB1-mutant NSCLC respectively.
Correlative/Exploratory Objectives:
* Explore the association of baseline genomic profiles (from tumor, germline DNA, and ctDNA) with clinical benefit in patients treated with sarilumab and cemiplimab combination
* Explore the association of immune profiles (tumor immune microenvironment features) with clinical benefit in patients treated with sarilumab and cemiplimab combination
* Explore resistance mechanisms to sarilumab and cemiplimab combination.
* Determine the impact of sarilumab on immunotherapy-related side effects from cemiplimab.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2023-00573 | OTHER | Clinical Trials Reporting Program | View |