Non-small Cell Lung CancerPhase 2NCT03916627
Neoadjuvant Cemiplimab for the Treatment of Resectable NSCLC, HCC, and HNSCC in Adult Patients
A Phase 2 study testing cemiplimab, Platinum Doublet and fianlimab in people with Non-small Cell Lung Cancer and Hepatocellular Carcinoma, run by Regeneron Pharmaceuticals at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Hepatocellular Carcinoma, Head and Neck Squamous Cell Carcinoma
- What is being tested?
- cemiplimab, Platinum Doublet and fianlimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2019to 14 May 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must have a known diagnosis of NSCLC, HCC, or HNSCC as defined in the protocol
- Patient must be willing and able to provide blood samples at the indicated time points
- Patient must be willing and able to have excisional or core needle biopsies of tumor prior to initiation of cemiplimab as defined in the protocol
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Patient is determined to be a surgical candidate for resection of their tumor
- Adequate organ and bone marrow function as defined in the protocol
Who cannot join
- Patients who have had any systemic anti-cancer therapy or radiotherapy within 6 months prior to entering the study for their current tumor or a different primary tumor
- Patients whose tumor burden, or pace of tumor growth, in the opinion of the Investigator will not permit delaying surgery
- Patients who have participated in a study of an investigational agent or an investigational device within 4 weeks of study therapy or 5 half-lives (whichever is longer)
- Patients who have had major surgery within 14 days prior to initiation of neoadjuvant Therapy
- Patients with metastatic disease for whom the intent of surgery would not be curative
- Uncontrolled, intercurrent illness as defined in the protocol and as determined by the Investigator
Show all 15Show fewer
- Is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
- Has active autoimmune disease that has required systemic treatment in the past 1 year
- Has a known, additional malignancy that is progressing and/or requires active treatment. Exceptions include patients with: basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy; in situ cervical or anal cancer; prostate cancer on stable dose of hormonal therapy without rising prostate-specific antigen (PSA); breast cancer who have been treated with curative intent, who may be on hormonal therapy.
- Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent
- History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management. A history of radiation pneumonitis in the radiation field is permitted as long as pneumonitis resolved ≥6 months prior to study treatment.
- Uncontrolled infection with human immunodeficiency virus (HIV), HBV or hepatitis C infection (HCV); or diagnosis of immunodeficiency as defined in the protocol
- NSCLC cohorts only: Patients do not have a history of smoking. History of smoking is defined as smoking ≥100 cigarettes in a lifetime.
- NSCLC cohorts only: Patients with tumors tested positive for epidermal growth factor receptor (EGFR) gene mutations, anaplastic lymphoma kinase (ALK) gene translocations, or c-ros oncogene 1 (ROS1) fusions.
- Note: Other protocol defined Inclusion/Exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: A Multi-Cohort Exploratory Study of Neoadjuvant Cemiplimab for the Treatment of Resectable NSCLC, HCC, and HNSCC
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)
- Conditions
- Non-small Cell Lung Cancer, Hepatocellular Carcinoma, Head and Neck Squamous Cell Carcinoma
- Being tested
- cemiplimab, Platinum Doublet, fianlimab
- Keywords
- NSCLC, HCC, HNSCC, Resectable
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Hepatocellular, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cemiplimabDrug
Also called REGN2810, Libtayo
Administered intravenous (IV)
Platinum DoubletDrug
Administered intravenous (IV)
fianlimabDrug
Also called REGN3767
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| Cohort A1 | Experimental | Cemiplimab prior to surgery; cemiplimab and platinum doublet post surgery (NSCLC) Not open for accrual Receives: Drug: cemiplimab; Drug: Platinum Doublet |
| Cohort A2 | Experimental | Cemiplimab and platinum doublet prior to surgery; cemiplimab and platinum doublet post surgery (NSCLC) Not open for accrual Receives: Drug: cemiplimab; Drug: Platinum Doublet |
| Cohort A3 | Experimental | Platinum doublet prior to surgery; cemiplimab and platinum doublet post surgery (NSCLC) Not open for accrual Receives: Drug: cemiplimab; Drug: Platinum Doublet |
| Cohort B | Experimental | Cemiplimab prior to surgery; cemiplimab post surgery (HCC) Receives: Drug: cemiplimab |
| Cohort C | Experimental | Cemiplimab prior to surgery; standard of care radiation and/or chemotherapy followed by cemiplimab post surgery (HNSCC) Not open for accrual Receives: Drug: cemiplimab |
| Cohort B2 | Experimental | SBRT 8 Gy X 3 fractions followed by cemiplimab prior to surgery; cemiplimab post surgery (HCC) Receives: Drug: cemiplimab |
| Cohort B3 | Experimental | Cemiplimab and fianlimab before and after surgery (HCC) Receives: Drug: cemiplimab; Drug: fianlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major pathologic response (MPR) at time of surgery for the NSCLC cohorts
Cohorts A1, A2, A3
Measured: At time of surgery
Significant tumor necrosis (STN) at time of surgery is the primary endpoint for the HCC cohorts
Cohort B, B2, B3
Measured: At time of surgery
Major treatment effect (MTE) at time of surgery is the primary endpoint for the HNSCC cohort
Cohort C
Measured: At time of surgery
Secondary outcomes (17)
Delay to surgery
Defined as surgery >28 days following the end of the second cycle of cohort specific neoadjuvant therapy
Measured: Surgery >28 days following the end of the cycle of last dose of cemiplimab
Event-free survival (EFS)
Defined as the time from the first study treatment to the date of disease progression that precluded definitive surgery, or recurrence of tumor after successful surgery, or death from any cause.
Measured: Up to 60 months following surgery
Disease-free survival (DFS)
Defined as the time from date of surgery until recurrence of tumor or death from any cause after successful surgery and recovery
Measured: Up to 60 months following surgery
Overall response rate (ORR)
Defined as the percent of patients with a complete response (CR) or partial response (PR) documented by the Investigator per RECIST 1.1. as described in the protocol
Measured: Up to 60 months following surgery
Overall survival (OS)
Defined as the time from the first study treatment and date of death for any reason
Measured: Up to 60 months following surgery
OS rate
Measured: 12 months
OS rate
Measured: 18 months
OS rate
Measured: 24 months
OS rate
Measured: 36 months
OS rate
Measured: 48 months
OS rate
Measured: 60 months
Incidence of treatment emergent adverse events (TEAEs)
Grade 3 or higher per Common Terminology Criteria for Adverse Events (CTCAE V5.0)
Measured: Up to 60 months following surgery
Incidence of imAEs
Grade 3 or higher per Common Terminology Criteria for Adverse Events (CTCAE V5.0)
Measured: Up to 60 months following surgery
Incidence of SAEs
Grade 3 or higher per Common Terminology Criteria for Adverse Events (CTCAE V5.0)
Measured: Up to 60 months following surgery
Incidence of deaths
Measured: Up to 60 months following surgery
Incidence of laboratory abnormalities
Grade 3 or higher per Common Terminology Criteria for Adverse Events (CTCAE V5.0)
Measured: Up to 60 months following surgery
Change in tumor-infiltrating CD8 T-cell density
Defined as the change from baseline to the time of surgery
Measured: Baseline to time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start23 Jul 2019
- Primary completion31 Mar 2025
- Study completion14 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03916627
- Sponsor's protocol ID
- R2810-ONC-1866
- Status last verified
- Jan 2026
- First submitted
- 5 Apr 2019
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Publications
D'Alessio A, Stefanini B, Blanter J, Adegbite B, Crowley F, Yip V, Slater S, Fulgenzi CAM, Celsa C, Manfredi GF, Pai M, Goldin RD, Ward SC, Fiel MI, Shu DH, Su YY, Cortellini A, Baretti M, Anders R, Yarchoan M, Hsu C, Marron TU, Pinato DJ. Pathological response following neoadjuvant immune checkpoint inhibitors in patients with hepatocellular carcinoma: a cross-trial, patient-level analysis. Lancet Oncol. 2024 Nov;25(11):1465-1475. doi: 10.1016/S1470-2045(24)00457-1. Epub 2024 Oct 19.
PubMed 39437804Marron TU, Fiel MI, Hamon P, Fiaschi N, Kim E, Ward SC, Zhao Z, Kim J, Kennedy P, Gunasekaran G, Tabrizian P, Doroshow D, Legg M, Hammad A, Magen A, Kamphorst AO, Shareef M, Gupta NT, Deering R, Wang W, Wang F, Thanigaimani P, Mani J, Troncoso L, Tabachnikova A, Chang C, Akturk G, Buckup M, Hamel S, Ioannou G, Hennequin C, Jamal H, Brown H, Bonaccorso A, Labow D, Sarpel U, Rosenbloom T, Sung MW, Kou B, Li S, Jankovic V, James N, Hamon SC, Cheung HK, Sims JS, Miller E, Bhardwaj N, Thurston G, Lowy I, Gnjatic S, Taouli B, Schwartz ME, Merad M. Neoadjuvant cemiplimab for resectable hepatocellular carcinoma: a single-arm, open-label, phase 2 trial. Lancet Gastroenterol Hepatol. 2022 Mar;7(3):219-229. doi: 10.1016/S2468-1253(21)00385-X. Epub 2022 Jan 20.
PubMed 35065058
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Cohort Exploratory Study of Neoadjuvant Cemiplimab for the Treatment of Resectable NSCLC, HCC, and HNSCC
- ClinicalTrials.gov ID
- NCT03916627
- Acronym / sponsor ID
- R2810-ONC-1866
- Conditions
- Non-small Cell Lung Cancer, Hepatocellular Carcinoma, Head and Neck Squamous Cell Carcinoma
- Keywords
- NSCLC, HCC, HNSCC, Resectable
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 23 Jul 2019 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 14 May 2030 (estimated)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort A1 | Experimental | Drug: cemiplimab, Drug: Platinum DoubletCemiplimab prior to surgery; cemiplimab and platinum doublet post surgery (NSCLC) Not open for accrual |
| Cohort A2 | Experimental | Drug: cemiplimab, Drug: Platinum DoubletCemiplimab and platinum doublet prior to surgery; cemiplimab and platinum doublet post surgery (NSCLC) Not open for accrual |
| Cohort A3 | Experimental | Drug: cemiplimab, Drug: Platinum DoubletPlatinum doublet prior to surgery; cemiplimab and platinum doublet post surgery (NSCLC) Not open for accrual |
| Cohort B | Experimental | Drug: cemiplimabCemiplimab prior to surgery; cemiplimab post surgery (HCC) |
| Cohort C | Experimental | Drug: cemiplimabCemiplimab prior to surgery; standard of care radiation and/or chemotherapy followed by cemiplimab post surgery (HNSCC) Not open for accrual |
| Cohort B2 | Experimental | Drug: cemiplimabSBRT 8 Gy X 3 fractions followed by cemiplimab prior to surgery; cemiplimab post surgery (HCC) |
| Cohort B3 | Experimental | Drug: cemiplimab, Drug: fianlimabCemiplimab and fianlimab before and after surgery (HCC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient must have a known diagnosis of NSCLC, HCC, or HNSCC as defined in the protocol
- Patient must be willing and able to provide blood samples at the indicated time points
- Patient must be willing and able to have excisional or core needle biopsies of tumor prior to initiation of cemiplimab as defined in the protocol
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Patient is determined to be a surgical candidate for resection of their tumor
Key exclusion criteria (15 listed)
- Patients who have had any systemic anti-cancer therapy or radiotherapy within 6 months prior to entering the study for their current tumor or a different primary tumor
- Patients whose tumor burden, or pace of tumor growth, in the opinion of the Investigator will not permit delaying surgery
- Patients who have participated in a study of an investigational agent or an investigational device within 4 weeks of study therapy or 5 half-lives (whichever is longer)
- Patients who have had major surgery within 14 days prior to initiation of neoadjuvant Therapy
- Patients with metastatic disease for whom the intent of surgery would not be curative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cemiplimabAlso: REGN2810, LibtayoAdministered intravenous (IV) | Drug | Cohort A1, Cohort A2, Cohort A3, Cohort B, Cohort B2, Cohort B3, Cohort C |
| Platinum DoubletAdministered intravenous (IV) | Drug | Cohort A1, Cohort A2, Cohort A3 |
| fianlimabAlso: REGN3767Administered IV | Drug | Cohort B3 |
Primary outcome
Major pathologic response (MPR) at time of surgery for the NSCLC cohorts
Time frame: At time of surgery
Cohorts A1, A2, A3
Significant tumor necrosis (STN) at time of surgery is the primary endpoint for the HCC cohorts
Time frame: At time of surgery
Cohort B, B2, B3
Major treatment effect (MTE) at time of surgery is the primary endpoint for the HNSCC cohort
Time frame: At time of surgery
Cohort C
17 secondary outcomes
Delay to surgery
Time frame: Surgery >28 days following the end of the cycle of last dose of cemiplimab
Event-free survival (EFS)
Time frame: Up to 60 months following surgery
Disease-free survival (DFS)
Time frame: Up to 60 months following surgery
Overall response rate (ORR)
Time frame: Up to 60 months following surgery
Overall survival (OS)
Time frame: Up to 60 months following surgery
OS rate
Time frame: 12 months
OS rate
Time frame: 18 months
OS rate
Time frame: 24 months
OS rate
Time frame: 36 months
OS rate
Time frame: 48 months
OS rate
Time frame: 60 months
Incidence of treatment emergent adverse events (TEAEs)
Time frame: Up to 60 months following surgery
Incidence of imAEs
Time frame: Up to 60 months following surgery
Incidence of SAEs
Time frame: Up to 60 months following surgery
Incidence of deaths
Time frame: Up to 60 months following surgery
Incidence of laboratory abnormalities
Time frame: Up to 60 months following surgery
Change in tumor-infiltrating CD8 T-cell density
Time frame: Baseline to time of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Derived from this study: PubMed 39437804D'Alessio A, Stefanini B, Blanter J, Adegbite B, Crowley F, Yip V, Slater S, Fulgenzi CAM, Celsa C, Manfredi GF, Pai M, Goldin RD, Ward SC, Fiel MI, Shu DH, Su YY, Cortellini A, Baretti M, Anders R, Yarchoan M, Hsu C, Marron TU, Pinato DJ. Pathological response following neoadjuvant immune checkpoint inhibitors in patients with hepatocellular carcinoma: a cross-trial, patient-level analysis. Lancet Oncol. 2024 Nov;25(11):1465-1475. doi: 10.1016/S1470-2045(24)00457-1. Epub 2024 Oct 19.
- Derived from this study: PubMed 35065058Marron TU, Fiel MI, Hamon P, Fiaschi N, Kim E, Ward SC, Zhao Z, Kim J, Kennedy P, Gunasekaran G, Tabrizian P, Doroshow D, Legg M, Hammad A, Magen A, Kamphorst AO, Shareef M, Gupta NT, Deering R, Wang W, Wang F, Thanigaimani P, Mani J, Troncoso L, Tabachnikova A, Chang C, Akturk G, Buckup M, Hamel S, Ioannou G, Hennequin C, Jamal H, Brown H, Bonaccorso A, Labow D, Sarpel U, Rosenbloom T, Sung MW, Kou B, Li S, Jankovic V, James N, Hamon SC, Cheung HK, Sims JS, Miller E, Bhardwaj N, Thurston G, Lowy I, Gnjatic S, Taouli B, Schwartz ME, Merad M. Neoadjuvant cemiplimab for resectable hepatocellular carcinoma: a single-arm, open-label, phase 2 trial. Lancet Gastroenterol Hepatol. 2022 Mar;7(3):219-229. doi: 10.1016/S2468-1253(21)00385-X. Epub 2022 Jan 20.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Management study director
Regeneron Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cemiplimab, Platinum Doublet and fianlimab in people with Non-small Cell Lung Cancer and Hepatocellular Carcinoma, run by Regeneron Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major pathologic response (MPR) at time of surgery for the NSCLC cohorts (time frame: At time of surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03916627, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.