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NCT03916627
Neoadjuvant Cemiplimab for the Treatment of Resectable NSCLC, HCC, and HNSCC in Adult Patients
Phase 2 trial testing cemiplimab in Non-small Cell Lung Cancer in 65 participants. Participants enrolled and being followed up; not accepting new ones.
31 March 2025
Quick facts
| Lead sponsor | Regeneron Pharmaceuticals |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 65 |
| Start date | 23 July 2019 |
| Primary completion | 31 March 2025 |
| Estimated completion | 14 May 2030 |
| Sites | 1 location across United States |
Drugs / interventions tested
- cemiplimab (CEMIPLIMAB) — full drug profile →
- Platinum Doublet — full drug profile →
- fianlimab — full drug profile →
Conditions studied
- Non-small Cell Lung Cancer — all drugs for Non-small Cell Lung Cancer →
- Hepatocellular Carcinoma — all drugs for Hepatocellular Carcinoma →
- Head and Neck Squamous Cell Carcinoma — all drugs for Head and Neck Squamous Cell Carcinoma →
Sponsor
Regeneron Pharmaceuticals — full company profile →
Who can join
18 and older, any sex, with Non-small Cell Lung Cancer or Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is being done to better understand whether or not cemiplimab by itself and in combination with other treatments given prior to surgery will cause your tumor to respond in a beneficial way; whether the drug(s) are safe and what side effects they cause; and other details about how they function in the body. One of the treatments that will be combined cemiplimab is another experimental drug called fianlimab. In this form, cemiplimab and fianlimab will each individually be called "study drug" or "study drugs" when combined. Cemiplimab (also known as REGN2810) and fianlimab (also known as REGN3767) are both a type of drug called a monoclonal antibody. Antibodies are proteins naturally found in your blood that fight infections. A monoclonal antibody is a special kind of antibody that is manufactured as a medication to target specific proteins in the body that may be involved in your cancer. * Cemiplimab is a drug that blocks the programmed death receptor 1 (PD-1), a cell receptor on immune cells * Fianlimab is a drug that blocks the action of a protein called lymphocyte activation gene (LAG)-33 (LAG-3)
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Intratumoral dendritic cell-CD4<sup>+</sup> T helper cell niches enable CD8<sup>+</sup> T cell differentiation following PD-1 blockade in hepatocellular carcinoma.
Magen A, Hamon P, Fiaschi N, Soong BY, et al · · 2023 · cited 324× · PMID 37322116 · DOI 10.1038/s41591-023-02345-0 -
Targeting LAG-3, TIM-3, and TIGIT for cancer immunotherapy.
Cai L, Li Y, Tan J, Xu L, et al · · 2023 · cited 232× · PMID 37670328 · DOI 10.1186/s13045-023-01499-1 -
Neoadjuvant cemiplimab for resectable hepatocellular carcinoma: a single-arm, open-label, phase 2 trial.
Marron TU, Fiel MI, Hamon P, Fiaschi N, et al · · 2022 · cited 192× · PMID 35065058 · DOI 10.1016/s2468-1253(21)00385-x -
Emerging immunotherapy for HCC: A guide for hepatologists.
Foerster F, Gairing SJ, Ilyas SI, Galle PR. · · 2022 · cited 185× · PMID 35253934 · DOI 10.1002/hep.32447 -
Research Status and Outlook of PD-1/PD-L1 Inhibitors for Cancer Therapy.
Ai L, Chen J, Yan H, He Q, et al · · 2020 · cited 149× · PMID 32982171 · DOI 10.2147/dddt.s267433 -
Neoadjuvant immunotherapy for non-small cell lung cancer: State of the art.
Kang J, Zhang C, Zhong WZ. · · 2021 · cited 121× · PMID 33689225 · DOI 10.1002/cac2.12153 -
Immune Regulatory Processes of the Tumor Microenvironment under Malignant Conditions.
Pansy K, Uhl B, Krstic J, Szmyra M, et al · · 2021 · cited 87× · PMID 34948104 · DOI 10.3390/ijms222413311 -
Targets of Immune Escape Mechanisms in Cancer: Basis for Development and Evolution of Cancer Immune Checkpoint Inhibitors.
Dutta S, Ganguly A, Chatterjee K, Spada S, et al · · 2023 · cited 81× · PMID 36829496 · DOI 10.3390/biology12020218
Verify or expand the search:
- PubMed search for NCT03916627
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of cemiplimab
Trials testing the same drug.
- NCT06384820 — Study of Cemiplimab Alone or in Combination With Fianlimab and/or Other Experimental Agents in Adult Participants With P · Phase 2 · withdrawn
- NCT06190951 — A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better Than Anti-PD1 Alone in Adult Participants With Res · Phase 2 · active not recruiting
- NCT06246916 — A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melan · Phase 3 · recruiting
- NCT05800015 — A Trial to Learn How the Combination of Fianlimab With Cemiplimab and Chemotherapy Works Compared With Cemiplimab and Ch · Phase 2, PHASE3 · active not recruiting
- NCT05785767 — A Study to Learn if a Combination of Fianlimab and Cemiplimab Versus Cemiplimab Alone is More Effective for Adult Partic · Phase 2, PHASE3 · active not recruiting
Other recruiting trials for Non-small Cell Lung Cancer
Currently open trials in the same condition.
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Other Regeneron Pharmaceuticals trials
Trials by the same sponsor.
- NCT07428369 — A Study of Linvo-VR vs DVRd in Transplant-Eligible Adult Participants With Newly Diagnosed Multiple Myeloma (NDMM) · Phase 2, PHASE3 · not yet recruiting
- NCT07526116 — A First in Human Study to Assess Safety, Tolerability and Pharmacokinetics of a Single Dose of REGN22044 in Healthy Adul · Phase 1 · not yet recruiting
- NCT07527923 — First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis · Phase 1 · not yet recruiting
- NCT07527910 — A Phase 2a Study of ALN-PNP With and Without a GLP1R Agonist in Adult Patients With Homozygous PNPLA3-Related MASLD · Phase 2 · not yet recruiting
- NCT07477704 — A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemi · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03916627 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Regeneron Pharmaceuticals
- Last refreshed: 6 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03916627.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing