NCT05704634

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	Cemiplimab	Given by Injection under the skin every 2 weeks
DRUG	Kevzara (Sarilumab)	Given by IV (vein) over about 30 minutes every 3 weeks.

Timeline

• Start date: 2023-08-18
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2023-01-30
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study