Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-25 @ 2:21 AM
NCT ID:
NCT05704634
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.
Study:
NCT05704634
Study Brief:
Protocol Section:
NCT05704634