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.
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.