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BNT116

Phase 2

Advanced Non-Small Cell Lung Cancer | Small molecule | Oncology |Regeneron Pharmaceuticals, Inc.|Last Updated: May 6, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedCONTROLLED
Total Trials1
Total Enrollment51
FDA Designations
No designations recorded
Clinical trial landscape

BNT116 · 1 trial · 1 indication

Phase 2 1
NCT05557591A Trial to Learn How the Cancer Vaccine BNT116 in Combination With Cemiplimab Works and How Safe the Combination is in Adults With Advanced Non-small Cell Lung Cancer (EMPOWERVAX Lung 1)Advanced Non-Small Cell Lung Cancer
ACTIVE NOT_RECRUITING51 Analytics
PHASE2ACTIVE NOT_RECRUITING
A Trial to Learn How the Cancer Vaccine BNT116 in Combination With Cemiplimab Works and How Safe the Combination is in Adults With Advanced Non-small Cell Lung Cancer (EMPOWERVAX Lung 1)
Advanced Non-Small Cell Lung Cancer
NCT0555759151
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Study Endpoints
Primary Endpoints
Objective response rate (ORR) as assessed by blinded independent review committee (BIRC) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
Up to 136 weeks from randomization

Proportion of patients with a best overall response of confirmed complete response (CR) or partial response (PR)

Secondary Endpoints
ORR by investigator assessment
Up to 136 weeks from randomization
Duration of Response (DOR) as assessed by BIRC using RECIST 1.1
Up to 3 years from last patient randomized
DOR by investigator assessment
Up to 3 years from last patient randomized
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Phase 2: CemiplimabEXPERIMENTALArm A: Cemiplimab is administered by IV infusion Q3W
Phase 2: BNT116 + CemiplimabEXPERIMENTALArm B: BNT116 is administered by IV injection. Cemiplimab is administered by IV infusion Q3W.
Interventions
NameTypeDescription
BNT116DRUGBNT116 is administered by IV injection.
CemiplimabDRUGCemiplimab is administered Q3W by IV infusion
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites52

Key Inclusion Criteria 1. Participants with non-squamous or squamous histology NSCLC with stage IIIB or stage IIIC disease who are not candidates for surgical resection or definitive chemoradiation per investigator assessment or stage IV (metastatic) disease who received no prior systemic treatment...

Countries:United StatesGeorgiaGermanySouth KoreaSpainTaiwanTurkey (Türkiye)
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Competitive Landscape -Non-Small Cell Lung Cancer 395 trials (matched to "Advanced Non-Small Cell Lung Cancer")

Top 20 of 86 competitors

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK25PHASE3Pembrolizumab, Olaparib, Etoposide, Carboplatin, Cisplatin
AstraZeneca PLCAZN62PHASE3Datopotamab deruxtecan, Durvalumab, Carboplatin, Pembrolizumab, Cisplatin
Revolution Medicines, Inc.RVMD8PHASE3daraxonrasib, docetaxel
Eli Lilly and CompanyLLY19PHASE3Selpercatinib, Carboplatin, Cisplatin, Pemetrexed, Pembrolizumab
AbbVie, Inc.ABBV10PHASE3Telisotuzumab Vedotin, Docetaxel
Amgen Inc.AMGN5PHASE3AMG 510, Docetaxel
Bristol-Myers Squibb CompanyBMY19PHASE3Repotrectinib, Crizotinib
BioNTech SE Sponsored ADRBNTX7PHASE3Gotistobart, Docetaxel
Gilead Sciences, Inc.GILD4PHASE3Sacituzumab Govitecan-hziy, Docetaxel
Johnson & JohnsonJNJ17PHASE3Lazertinib, Amivantamab, Pemetrexed, Carboplatin
ArriVent BioPharma, Inc.AVBP9PHASE3Firmonertinib
Pfizer Inc.PFE17PHASE3Lorlatinib, Crizotinib
GSK plc Sponsored ADRGSK4PHASE3Dostarlimab, Belrestotug, Pembrolizumab
Novartis AG Sponsored ADRNVS9PHASE3JDQ443, docetaxel
Summit Therapeutics IncSMMT2PHASE3Ivonescimab, Pembrolizumab
Nuvation Bio, Inc. Class ANUVB4PHASE3Taletrectinib, Crizotinib
Genmab A/S Sponsored ADRGMAB4PHASE3Acasunlimab, Pembrolizumab, Docetaxel
Regeneron Pharmaceuticals, Inc.REGN6PHASE2cemiplimab, Platinum Doublet, fianlimab
BeOne Medicines Ltd. Sponsored ADRONC6PHASE3Tislelizumab, Cisplatin, Paclitaxel, Pemetrexed Disodium, Carboplatin
BeyondSpring Inc.BYSI1PHASE3Plinabulin, Docetaxel
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05557591primaryCompletionDate: changed
LOWMay 24, 2026NCT05557591studyFirstPostDate: changed