2023 North America Conference on Lung Cancer (NACLC) - Posters and Abstracts-PP01.85 (Poster) A Phase 2/3 Study of Fianlimab, Cemiplimab, plus Chemotherapy Versus Cemiplimab plus Chemotherapy in First-Line Advanced Non-Small Cell Lung Cancer

PP01.85 (Poster) A Phase 2/3 Study of Fianlimab, Cemiplimab, plus Chemotherapy Versus Cemiplimab plus Chemotherapy in First-Line Advanced Non-Small Cell Lung Cancer

Back to course

Pdf Summary

The present study is a Phase 2/3 clinical trial that aims to evaluate the efficacy and safety of fianlimab and cemiplimab in combination with chemotherapy for the treatment of advanced non-small cell lung cancer (NSCLC). The trial will enroll 950 treatment-naive patients with stage IIIB, stage IIIC, or stage IV squamous or non-squamous NSCLC, regardless of their programmed death-ligand 1 (PD-L1) expression levels.<br /><br />In the Phase 2 part of the study, 150 patients will be randomized into three treatment arms: one arm will receive fianlimab high dose plus cemiplimab and chemotherapy, another will receive fianlimab low dose plus cemiplimab and chemotherapy, and the third arm will receive cemiplimab and chemotherapy with a placebo. The dose of fianlimab for the Phase 3 part of the study will be determined based on the findings from Phase 2. In the Phase 3 part, 800 patients will be randomized into two treatment arms: one arm will receive fianlimab (high or low dose) plus cemiplimab and chemotherapy, and the other arm will receive cemiplimab and chemotherapy with a placebo.<br /><br />The primary endpoint of the study is the overall response rate, and secondary endpoints include overall survival, disease control rate, time to tumor response, duration of response, and progression-free survival. Exploratory endpoints include evaluating tumor burden reduction, tumor DNA/RNA sequencing, and gene expression characterization.<br /><br />Fianlimab is an investigational anti-LAG-3 monoclonal antibody that blocks LAG-3/major histocompatibility complex class II-driven T-cell inhibition. Cemiplimab is approved by the FDA for the treatment of certain types of non-small cell lung cancer and other cancers.<br /><br />The study is currently open for enrollment and is sponsored by Regeneron Pharmaceuticals, Inc.

Asset Subtitle

Nashat Gabrail

Keywords

Phase 2/3 clinical trial

fianlimab

cemiplimab

chemotherapy

non-small cell lung cancer

treatment-naive patients

PD-L1 expression levels

overall response rate

progression-free survival

Regeneron Pharmaceuticals Inc.