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cemiplimab

Phase 3

Non-small Cell Lung Cancer | Small molecule | Oncology |Regeneron Pharmaceuticals, Inc.|Last Updated: Apr 14, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDDMCBiomarker
Total Trials3
Total Enrollment575
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06931717A Clinical Study to Assess the Efficacy of Adjuvant Immunotherapy With Cemiplimab in Patients With Surgically Removed Non-small Cell Lung Cancer Who Have Not Received Prior ChemotherapyPHASE3 RECRUITING 390 — — Jan 12, 2026Mar 1, 2029Apr 14, 202633 Austria, Estonia +7
NCT06465329A Study of Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for Adult Patients With Operable Non-Small Cell Lung Cancer (NSCLC)PHASE2 RECRUITING 120 — — Nov 18, 2024May 2, 2030Feb 12, 202649 United States, Brazil +4
NCT03916627Neoadjuvant Cemiplimab for the Treatment of Resectable NSCLC, HCC, and HNSCC in Adult PatientsPHASE2 ACTIVE NOT_RECRUITING 65 — — Jul 23, 2019May 14, 2030Apr 6, 20261 United States
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Study Endpoints
Primary Endpoints
Disease-free survival (DFS)
From the date of randomisation until disease recurrence (including loco-regional recurrence, a distant (metastatic) recurrence or a second primary) or death from any cause. Assessed for approximately up to 59 months.

Disease free survival (in patients with tumours with centrally confirmed PD-L1 expression of ≥1%).

Major pathologic response (MPR) rate as determined by central blinded independent pathology review (BIPR)
Up to 12 weeks
Major pathologic response (MPR) at time of surgery for the NSCLC cohorts
At time of surgery

Cohorts A1, A2, A3

Significant tumor necrosis (STN) at time of surgery is the primary endpoint for the HCC cohorts
At time of surgery

Cohort B, B2, B3

Major treatment effect (MTE) at time of surgery is the primary endpoint for the HNSCC cohort
At time of surgery

Cohort C

Secondary Endpoints
Overall survival (OS)
From the date of randomisation until death from any cause. Assessed for approximately up to 59 months.
Incidence, nature and severity of adverse events according to CTCAE v5.
From the date the patient has signed the Informed Consent until the trial end. Assessed for approximately up to 59 months.
Pathologic complete response (pCR) rate as determined by central BIPR
Up to 12 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Experimental Arm: CemiplimabEXPERIMENTALCemiplimab, 350 mg i.v., every 3 weeks (±3 days), for 4 cycles, followed by 700 mg i.v., every 6 weeks (±1 week) for 6 cycles or until relapse or unacceptable toxicities, whichever occurs first.
Control Arm: ObservationNO_INTERVENTIONObservation.
Chemotherapy+CemiplimabACTIVE_COMPARATORControl treatment
Arm 1: Chemotherapy+Cemiplimab+REGN7075EXPERIMENTALInvestigational Treatment
Cohort A1EXPERIMENTALCemiplimab prior to surgery; cemiplimab and platinum doublet post surgery (NSCLC) Not open for accrual
Cohort A2EXPERIMENTALCemiplimab and platinum doublet prior to surgery; cemiplimab and platinum doublet post surgery (NSCLC) Not open for accrual
Cohort A3EXPERIMENTALPlatinum doublet prior to surgery; cemiplimab and platinum doublet post surgery (NSCLC) Not open for accrual
Cohort BEXPERIMENTALCemiplimab prior to surgery; cemiplimab post surgery (HCC)
Cohort CEXPERIMENTALCemiplimab prior to surgery; standard of care radiation and/or chemotherapy followed by cemiplimab post surgery (HNSCC) Not open for accrual
Cohort B2EXPERIMENTALSBRT 8 Gy X 3 fractions followed by cemiplimab prior to surgery; cemiplimab post surgery (HCC)
Cohort B3EXPERIMENTALCemiplimab and fianlimab before and after surgery (HCC)
Interventions
NameTypeDescription
CemiplimabDRUGCemiplimab, 350 mg i.v., every 3 weeks (±3 days), for 4 cycles, followed by 700 mg i.v., every 6 weeks (±1 week) for 6 cycles or until relapse or unacceptable toxicities, whichever occurs first.
Platinum-based chemotherapyDRUGIV infusion
REGN7075DRUGIV infusion
Platinum DoubletDRUGAdministered intravenous (IV)
fianlimabDRUGAdministered IV
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites33

Inclusion Criteria: * Pathological stage II-IIIA (UICC/ AJCC staging 9th edition) NSCLC Brain imaging should have been performed to complete staging, either preoperatively or postoperatively. If brain imaging has not been performed, a contrast-enhanced CT or MRI of the brain must be performed at sc...

Countries:AustriaEstoniaFranceGermanyIrelandItalySingaporeSpainSwitzerlandUnited StatesBrazilTurkey (Türkiye)
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Competitive Landscape -Non-Small Cell Lung Cancer 406 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK25PHASE3Pembrolizumab, Olaparib, Etoposide, Carboplatin, Cisplatin
Amgen Inc.AMGN5PHASE3AMG 510, Docetaxel, ABP 234, Pembrolizumab, Sotorasib
AstraZeneca PLCAZN63PHASE3Datopotamab deruxtecan, Durvalumab, Carboplatin, Pembrolizumab, Cisplatin
Revolution Medicines, Inc.RVMD8PHASE3daraxonrasib, docetaxel, RMC-6291, Elironrasib, Daraxonrasib
Eli Lilly and CompanyLLY19PHASE3Selpercatinib, Carboplatin, Cisplatin, Pemetrexed, Pembrolizumab
AbbVie, Inc.ABBV10PHASE3Telisotuzumab Vedotin, Docetaxel, Telisotuzumab vedotin, Telisotuzumab Adizutecan, Livmoniplimab
Bristol-Myers Squibb CompanyBMY20PHASE3Repotrectinib, Crizotinib, Nivolumab, Carboplatin, Cisplatin
BioNTech SE Sponsored ADRBNTX7PHASE3Gotistobart, Docetaxel, PM8002, Carboplatin, Pemetrexed
Gilead Sciences, Inc.GILD4PHASE3Sacituzumab Govitecan-hziy, Docetaxel, Zimberelimab, Domvanalimab, Pembrolizumab
GSK plc Sponsored ADRGSK4PHASE3Cobolimab, Dostarlimab, Docetaxel, Belrestotug, Pembrolizumab
Johnson & JohnsonJNJ18PHASE3Lazertinib, Amivantamab, Pemetrexed, Carboplatin, Osimertinib
Pfizer Inc.PFE21PHASE3Lorlatinib, Crizotinib, Avelumab, Lorlatanib, Talazoparib
ArriVent BioPharma, Inc.AVBP9PHASE3Firmonertinib, Drug: Furmonertinib, Furmonertinib, JAB-21822, JAB 21822
Novartis AG Sponsored ADRNVS9PHASE3JDQ443, docetaxel, TNO155, tislelizumab, DKY709
Summit Therapeutics IncSMMT2PHASE3Ivonescimab, Pembrolizumab
Nuvation Bio, Inc. Class ANUVB4PHASE3Taletrectinib, Crizotinib, AB-106
Genmab A/S Sponsored ADRGMAB4PHASE3Acasunlimab, Pembrolizumab, Docetaxel, Rina-S, GEN1042
Incyte CorporationINCY1PHASE3Retifanlimab, Pemetrexed, Cisplatin, Carboplatin, Paclitaxel
Regeneron Pharmaceuticals, Inc.REGN6PHASE2cemiplimab, Platinum Doublet, fianlimab, Pemetrexed, Paclitaxel
BeOne Medicines Ltd. Sponsored ADRONC6PHASE3Tislelizumab, Cisplatin, Paclitaxel, Pemetrexed Disodium, Carboplatin
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06465329primaryCompletionDate: changed
LOWMay 26, 2026NCT03916627primaryCompletionDate: changed
LOWMay 24, 2026NCT06931717studyFirstPostDate: changed
LOWMay 24, 2026NCT06465329studyFirstPostDate: changed
LOWMay 24, 2026NCT03916627studyFirstPostDate: changed