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neoadjuvant therapy with Pembrolizumab/Lenvatinib

Phase 2

Non Small Cell Lung Cancer | Biologics | Oncology |Merck & Company, Inc.|Trials Updated: Nov 6, 2026

neoadjuvant therapy with Pembrolizumab/Lenvatinib development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since May 2021

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment33

FDA Designations

No designations recorded

neoadjuvant therapy with Pembrolizumab/Lenvatinib clinical trials

neoadjuvant therapy with Pembrolizumab/Lenvatinib · 1 trial · 1 indication

Phase 2 1
NCT04875585Trial Exploring Combined Neoadjuvant Therapy With Pembrolizumab/Lenvatinib + Adjuvant Pembrolizumab in Pat. With NSCLCNon Small Cell Lung Cancer
ACTIVE NOT_RECRUITING33 Analytics
PHASE2ACTIVE NOT_RECRUITING
Trial Exploring Combined Neoadjuvant Therapy With Pembrolizumab/Lenvatinib + Adjuvant Pembrolizumab in Pat. With NSCLC
Non Small Cell Lung Cancer
NCT0487558533
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Study Endpoints

Primary Endpoints

Major pathological response after neoadjuvant immunotherapy in combination with angiogenesis inhibition
2 years

Number of Participants Reaching a Major Pathological Response after Short Course Neoadjuvant Treatment with Pembrolizumab/Lenvatinib.

Secondary Endpoints

Radiologic response according to RECIST/iRECIST
2 years
Surgical resection rate
2 years
Disease free survival at 1, 2, 3 and 5 years
5 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment ArmEXPERIMENTALneoadjuvant therapy with Pembrolizumab/Lenvatinib in combination with surgical resection of primary tumor followed by adjuvant Pembrolizumab therapy

Interventions

NameTypeDescription
neoadjuvant therapy with Pembrolizumab/LenvatinibDRUGNeoadjuvant therapy for 6 weeks
SurgeryPROCEDUREsurgical resection of primary tumor and lymph-node-dissection.
Adjuvant Treatment PhaseDRUGAdjuvant treatment with 15 cycles of Pembrolizumab
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Male/female participants ≥18 years of age 2. Histologically confirmed primary diagnosis of resectable NSCLC, stages IA2-IIIA (max. single station N2). 3. Measurable disease based on RECIST 1.1. 4. Male participants must agree to use a contraception as detailed in Appendix 3 o...

Countries:Austria
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Competitive Landscape -Non-Small Cell Lung Cancer 554 trials (matched to "Non Small Cell Lung Cancer")

Top 20 of 88 competitors

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK40PHASE3Pembrolizumab, Olaparib, Sacituzumab tirumotecan, Intismeran autogene, Pembrolizumab Berahyaluronidase alfa
Revolution Medicines, Inc.RVMD9PHASE3Daraxonrasib, Zoldonrasib, Elironrasib, RMC-5127
Eli Lilly and CompanyLLY18PHASE3Selpercatinib, Pemetrexed, Abemaciclib, Olomorasib, LY3537982
AbbVie, Inc.ABBV12PHASE3Livmoniplimab, Budigalimab, Telisotuzumab Adizutecan, Telisotuzumab vedotin, ABBV-1480
AstraZeneca PLCAZN71PHASE3Datopotamab deruxtecan, Durvalumab, Oleclumab, Monalizumab, Tremelimumab
Gilead Sciences, Inc.GILD7PHASE3Sacituzumab govitecan, Zimberelimab, Domvanalimab, Etrumadenant, TUB-040- Dose escalation
Regeneron Pharmaceuticals, Inc.REGN7PHASE3Fianlimab, Cemiplimab, REGN5093, Marlotamig, REGN10597
Bristol-Myers Squibb CompanyBMY23PHASE3Repotrectinib, Nivolumab, Pumitamig, Iza-bren, relatlimab+nivolumab
GSK plc Sponsored ADRGSK4PHASE3Cobolimab, Dostarlimab, Belrestotug, Nelistotug
Johnson & JohnsonJNJ19PHASE3Lazertinib, Amivantamab, Cetrelimab, JNJ-90301900, JNJ-86974680
BioNTech SE Sponsored ADRBNTX7PHASE3Gotistobart, Pumitamig, BNT326, BNT116, BNT324
Pfizer Inc.PFE21PHASE3Lorlatinib, Crizotinib, Avelumab, Talazoparib, Axitinib
Amgen Inc.AMGN4PHASE3ABP 234, Sotorasib, Anvumetostat
ArriVent BioPharma, Inc.AVBP6PHASE3Firmonertinib
Summit Therapeutics IncSMMT2PHASE3Ivonescimab
Genmab A/S Sponsored ADRGMAB4PHASE3Acasunlimab, GEN1042, Rina-S
Nuvation Bio, Inc. Class ANUVB4PHASE3Taletrectinib
Eikon Therapeutics, Inc.EIKN3PHASE3EIK1001
Nuvalent, Inc. Class ANUVL1PHASE3Neladalkib
BeOne Medicines Ltd. Sponsored ADRONC7PHASE3Tislelizumab, BGB-A445, LBL-007, BGB-15025, BGB-43395
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