Regeneron’s Promising Phase 2 NSCLC Trial: A Potential Game Changer?

Regeneron Pharmaceuticals ((REGN)) announced an update on their ongoing clinical study.

Study Overview: Regeneron Pharmaceuticals is conducting a Phase 2 trial titled A Phase 2 Peri-Operative Trial of Fianlimab and Cemiplimab in Combination With Chemotherapy Versus Cemiplimab in Combination With Chemotherapy in Patients With Resectable Early Stage (Stage II to IIIB [N2]) NSCLC. The study aims to evaluate the effectiveness of combining fianlimab, cemiplimab, and chemotherapy compared to cemiplimab and chemotherapy alone in patients with resectable non-small cell lung cancer (NSCLC). The significance lies in potentially improving treatment outcomes for patients undergoing surgery.

Intervention/Treatment: The study tests fianlimab, cemiplimab, and platinum-doublet chemotherapy. Fianlimab and cemiplimab are administered intravenously every three weeks, aiming to enhance the efficacy of chemotherapy in treating NSCLC.

Study Design: This interventional study is randomized with a parallel assignment model. It employs quadruple masking, meaning participants, care providers, investigators, and outcomes assessors are blinded to the treatment allocation. The primary purpose is treatment-focused, aiming to assess the safety and efficacy of the drug combinations.

Study Timeline: The study began on July 16, 2024. The last update was submitted on June 23, 2025. These dates are crucial for tracking the study’s progress and ensuring timely updates on its findings.

Market Implications: This study could significantly impact Regeneron’s stock performance and investor sentiment, particularly if the combination therapy proves more effective. Success could position Regeneron favorably against competitors in the NSCLC treatment market, potentially leading to increased market share and investor interest.

The study is ongoing, with further details available on the ClinicalTrials portal.