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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.

Lung Cancer Clinical Trial

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.

Clinical Trial Summary

To learn if the combination of sarilumab (also called Kevzara) and cemiplimab can help to control EGFR- or LKB1/STK11-mutant NSCLC.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05704634
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Xiuning Le, MD,PHD
Phone 713-792-6980
Email xle1@mdanderson.org
Status Recruiting
Phase Phase 1
Start date August 18, 2023
Completion date January 1, 2028
View Details
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