2024 World Conference on Lung Cancer (WCLC) - Posters-P4.07D.03 Phase 2 Peri-Operative Study of Fianlimab+Cemiplimab+Chemotherapy vs Cemiplimab+Chemotherapy in Resectable Early-Stage NSCLC

P4.07D.03 Phase 2 Peri-Operative Study of Fianlimab+Cemiplimab+Chemotherapy vs Cemiplimab+Chemotherapy in Resectable Early-Stage NSCLC

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This document outlines a Phase 2 study focused on assessing the efficacy and safety of a combination therapy involving fianlimab, cemiplimab, and chemotherapy compared to cemiplimab and chemotherapy alone in patients with resectable early-stage non-small cell lung cancer (NSCLC). The study is conducted by a team of researchers from various institutions, under the funding of Regeneron Pharmaceuticals. The investigational treatment involves fianlimab (an anti-LAG-3 antibody) paired with cemiplimab (an anti-PD-1 antibody) and chemotherapy, with the hypothesis that the co-blockade of LAG-3 and PD-1 might enhance therapeutic efficacy for early-stage NSCLC patients.<br /><br />This randomized, double-blind, multicenter, global study is open for enrollment and targets patients with treatment-naïve, fully resectable stage II to IIIB NSCLC. Surgery is scheduled within six weeks post-treatment. Participants will be stratified by cancer stage, histology, and PD-L1 expression levels.<br /><br />The primary endpoints include pathological complete response (pCR) in resected tumor samples and event-free survival (EFS), with secondary endpoints covering safety, pharmacokinetics, immunogenicity, and patient-reported outcomes. Key inclusion criteria include patients aged 18 and above with confirmed NSCLC, no evidence of metastasis, and adequate organ function. Key exclusion criteria involve advanced or metastatic disease, actionable EGFR mutations, recent systemic autoimmune disease treatment, uncontrolled infections, and prior systemic cancer therapy.<br /><br />The study aims to establish the combination treatment as a potential new standard in the peri-operative management of early-stage NSCLC, with findings to be presented at the World Conference on Lung Cancer in September 2024.

Asset Subtitle

Luis Paz-Ares

Meta Tag

Speaker Luis Paz-Ares

Topic Early-Stage NSCLC

Keywords

Phase 2 study

fianlimab

cemiplimab

chemotherapy

non-small cell lung cancer

NSCLC

LAG-3

PD-1

Regeneron Pharmaceuticals

pathological complete response