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NCT06465329 · ClinicalTrials.gov record · last posted 2026-08-24

A Study of Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for Adult Patients With Operable Non-Small Cell Lung Cancer (NSCLC)

StatusActive, Not Recruiting
PhasePhase 2
Started2024-11-18
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from the ClinicalTrials.gov record
This study will enroll adult participants with early-stage (stage II-IIIB) non-small cell lung cancer for whom surgery is planned. The aim is to find out whether an investigational treatment (consisting of the immunotherapy drug cemiplimab plus chemotherapy plus a third drug) works better than cemiplimab plus chemotherapy without the additional drug. The study is also looking at several other research questions, including: * What are the side effects associated with the investigational treatments in comparison to the control treatment? * Do the investigational treatments or the control treatment have an effect on the type of surgery that is performed? * How much of the study drug(s) are in the blood at a given time? * Does the body make antibodies against the study drug(s) (which could make the drug(s) less effective or could lead to side effects)?

Protocol amendment history 2 changes detected by DataLookout

2026-08-25
notable
Enrollment closed, study ongoing
2026-08-25
minor
Trial sites reduced: 50 → 47 locations
Trial Details
NCT Number NCT06465329
Lead Sponsor Regeneron Pharmaceuticals
Conditions Non-Small Cell Lung Cancer
Enrollment 120 participants
Start Date 2024-11-18
Primary Completion 2027-05-20 (estimated)
Study Completion 2030-05-02 (estimated)
Updated on ClinicalTrials.gov 2026-08-24