Neoadjuvant Cemiplimab for the Treatment of Resectable NSCLC, HCC, and HNSCC in Adult Patients
← catalyst calendarSponsored by Regeneron Pharmaceuticals (industry) · REGN — their whole pipeline →.
Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
65actual
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2019-07-23 | actual | When the study began enrolling |
| Primary completion | 2025-03-31 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2030-05-14 | estimated | The whole study's end, after follow-up |
| First posted | 2019-04-16 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-06 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Non-small Cell Lung Cancer
- Hepatocellular Carcinoma
- Head and Neck Squamous Cell Carcinoma
Interventions
- Drug: cemiplimab — also filed as REGN2810, Libtayo
- Drug: Platinum Doublet
- Drug: fianlimab — also filed as REGN3767
Primary outcomes
what the primary-completion date above is the date OFMajor pathologic response (MPR) at time of surgery for the NSCLC cohorts
measured At time of surgery
Significant tumor necrosis (STN) at time of surgery is the primary endpoint for the HCC cohorts
measured At time of surgery
Major treatment effect (MTE) at time of surgery is the primary endpoint for the HNSCC cohort
measured At time of surgery
Publications
- PMID 39437804 — linked by the registry
- PMID 35065058 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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