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JDQ443

Phase 3

Non-Small Cell Lung Cancer | Small molecule | Oncology |Novartis AG|Last Updated: Jun 8, 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
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment95
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05132075Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung CancerPHASE3 ACTIVE NOT_RECRUITING 95Jun 15, 2022Sep 23, 2026Jun 8, 202652 United States, Argentina +23
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Study Endpoints
Primary Endpoints
Progression free survival (PFS)
Approximately up to 24 months

PFS is the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause. PFS is based on central assessment and using RECIST 1.1 criteria.

Secondary Endpoints
Overall Survival (OS)
Approximately up to 33 months
Overall Response Rate (ORR)
Approximately up to 33 months
Disease Control Rate (DCR)
Approximately up to 33 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
JDQ443EXPERIMENTALParticipants will be treated with JDQ443
DocetaxelACTIVE_COMPARATORParticipant will be treated with docetaxel following local guidelines as per standard of care and product labels
Interventions
NameTypeDescription
JDQ443DRUGJDQ443 tablets, orally administered
docetaxelDRUGdocetaxel concentrated solution for infusion, intravenously administered
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Eligibility Criteria
Age Range18 Years — 100 Years
SexALL
Healthy VolunteersNo
Study Sites52

Inclusion Criteria: * Participant has histologically confirmed locally advanced/metastatic (stage IIIB/IIIC or IV) * Participant has a KRAS G12C mutation present in tumor tissue or plasma prior to enrollment, as determined by a Novartis designated central laboratory or by accepted local tests. * Pa...

Countries:United StatesArgentinaAustraliaCanadaChinaFinlandGreeceHong KongHungaryIcelandIndiaItalyJordanLebanonMalaysiaMexicoPortugalRomaniaSloveniaSouth KoreaSpainTaiwanThailandTurkey (Türkiye)Vietnam
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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)
LOWJun 8, 2026NCT05132075lastUpdatePostDate: changed
LOWJun 8, 2026NCT05132075lastUpdatePostDate: changed
LOWJun 8, 2026NCT05132075lastUpdatePostDate: changed
LOWJun 2, 2026NCT05132075lastUpdatePostDate: changed
LOWJun 2, 2026NCT05132075lastUpdatePostDate: changed
LOWJun 2, 2026NCT05132075lastUpdatePostDate: changed
MEDIUMMay 26, 2026NCT05132075primaryCompletionDate: changed
LOWMay 24, 2026NCT05132075studyFirstPostDate: changed