CEMI-LUNG, an observational study to assess cemiplimab effectiveness and safety in patients with advanced non-small cell lung cancer in real-world clinical practice in Europe

Introduction Cemiplimab (an anti–PD-1 monoclonal antibody) is approved internationally as first-line (1L) treatment of non-small cell lung cancer (NSCLC), as monotherapy or with chemotherapy. The EMPOWER-Lung 1 and 3 trials have shown significant survival benefits for cemiplimab with/without chemotherapy in 1L advanced NSCLC (aNSCLC). There is a need for prospective data on cemiplimab effectiveness and safety in aNSCLC in real-world clinical practice (RCP). CEMI-LUNG is a phase 4, noninterventional, observational, longitudinal cohort study held in Europe. We provide the first interim descriptive analysis of an initial cohort of patients (pts) receiving cemiplimab monotherapy in RCP. Methods The study will enrol approximately 500 1L pts with either locally advanced NSCLC (laNSCLC) who are not suitable for definitive chemoradiation or metastatic NSCLC (mNSCLC) without actionable genetic aberrations, and who will initiate cemiplimab-based treatment per licensed indication as part of RCP across sites in Europe. The primary endpoint is overall survival. Here, we report baseline demographics and clinical characteristics for all pts who provided informed consent and received≥1 dose of cemiplimab monotherapy. Efficacy and safety data on cemiplimab with/without chemotherapy will be reported after longer follow-up. Results Among 121 pts included in this interim analysis who received≥1 dose of cemiplimab monotherapy, the median age was 72.0 years (IQR: 66.0–79.0; 35.5% were aged>75 years). Most pts were male (60.3%) and current/former smokers (91.7%). Overall, 13.2% had ECOG PS≥2, 78.5% had non-squamous and 14.9% had squamous histology, and 23.1% and 76.9% of pts had laNSCLC and mNSCLC, respectively. All pts had PD-L1≥50% (median PD-L1 80.0%); 45.5% had high (≥90%) PD-L1 expression. The median duration of treatment was 12.3 weeks, and follow-up was 5.1 months. Conclusions In this real-world study, pts with aNSCLC who received cemiplimab monotherapy were predominantly older, smokers, and had high PD-L1 (80%). Relative to the pt population of the EMPOWER-Lung trials, this real-world population had more female pts, pts with laNSCLC, older pts, and pts with ECOG PS≥2. Publication History Article published online: 04 March 2026 © 2026. Thieme. All rights reserved. Georg Thieme Verlag KG Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany