Libtayo (cemiplimab-rwlc)

P1, N=22, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Dec 2025 --> Aug 2026

As fasting alone failed to improve the symptoms, prednisolone (PSL) was initiated, resulting in amelioration of both symptoms and endoscopic findings. Cemiplimab-induced immune-related gastritis can be diagnosed based on its characteristic endoscopic and histopathological features, similar to irAE gastritis caused by other immune checkpoint inhibitors.

P2, N=135, Not yet recruiting, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

P1/2, N=933, Recruiting, Regeneron Pharmaceuticals | Trial completion date: Dec 2026 --> Apr 2027

P1, N=105, Active, not recruiting, Regeneron Pharmaceuticals | Trial completion date: Dec 2025 --> May 2026 | Trial primary completion date: Dec 2025 --> May 2026

Since 2022, immunotherapy is part of standard therapeutic strategy with pembrolizumab on the one hand, associated with chemotherapy and bevacizumab in patients with PD-L1 positive tumors (CPS≥1), and cemiplimab on the other hand, in patients who did not receive prior immunotherapy and progress after first line regardless of PD-L1 expression. Whenever possible, molecular screening and determination of HER2 status may allow orienting patients to clinical trials. Indeed, inclusion in investigational studies must be systematically considered and early supportive care is always recommended.

P2, N=11, Recruiting, City of Hope Medical Center | Initiation date: Dec 2025 --> Apr 2026

P2, N=180, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting | Initiation date: Feb 2026 --> Oct 2026

The landscape of first-line treatment for metastatic non-small cell lung cancer (NSCLC) without actionable driver mutations is rapidly evolving, currently dominated by pembrolizumab-based regimens. Secondly, cemiplimab displays consistent, robust efficacy in challenging-to-treat squamous histology, both as monotherapy for patients with high PD-L1 expression and in combination with chemotherapy for patients with PD-L1 < 50%. In conclusion, cemiplimab establishes a unique therapeutic niche for patients with squamous histology and ultra-high PD-L1 expression, likely driven by its distinct structural stability and reduced immunogenicity.

P2, N=44, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Dec 2027

P1, N=20, Not yet recruiting, Virginia Commonwealth University

P2, N=60, Active, not recruiting, Duke University | Trial completion date: Jan 2027 --> Mar 2026 | Trial primary completion date: Jan 2026 --> Sep 2025