M.D. Anderson Cancer Center
To learn if the combination of sarilumab (also called Kevzara) and cemiplimab can help to control EGFR- or LKB1/STK11-mutant NSCLC.
Lung Cancer
Cemiplimab
Kevzara (Sarilumab)
Phase 1
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 Type : | Interventional |
Estimated Enrollment : | 56 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
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. |
Actual Study Start Date : | August 18, 2023 |
Estimated Primary Completion Date : | January 1, 2026 |
Estimated Study Completion Date : | January 1, 2028 |
Arm | Intervention/treatment |
---|---|
Experimental: Cohort A : EGFR-mutant cohort Each cohort is planned for 30 Participants with a total of 60 Participants. Participants who are treated in Run-In safety cohort can also be evaluated for efficacy in the molecularly define cohort A or B. |
Drug: Cemiplimab Drug: Kevzara (Sarilumab) |
Experimental: Cohort B: LKB1-mutant cohort Each cohort is planned for 30 Participants with a total of 60 Participants. Participants who are treated in Run-In safety cohort can also be evaluated for efficacy in the molecularly define cohort A or B. |
Drug: Cemiplimab Drug: Kevzara (Sarilumab) |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
M D Anderson Cancer Center
Houston, Texas, United States, 77030