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Neladalkib

Phase 3

Non-small Cell Lung Cancer | Small molecule | Oncology |Nuvalent, Inc.|Last Updated: Jun 2, 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 Enrollment450
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06765109Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLCPHASE3 RECRUITING 450 — — Jul 17, 2025Dec 1, 2029Jun 2, 2026155 United States, Argentina +27
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Study Endpoints
Primary Endpoints
Progression-free survival (PFS) per blinded independent central review (BICR)
Up to 5 years after first patient dosed

Time from randomization to BICR-assessed radiographic disease progression or death

Secondary Endpoints
Overall survival (OS)
Up to 5 years after first patient dosed
Progression-free survival (PFS) per investigator assessment
Up to 5 years after first patient dosed
Time to intracranial progression per BICR
Up to 5 years after first patient dosed
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Neladalkib (NVL-655)EXPERIMENTAL150mg taken orally once daily (QD)
AlectinibACTIVE_COMPARATOR600mg taken orally twice daily (BID)
Interventions
NameTypeDescription
Neladalkib (NVL-655)DRUGOral tablet of Neladalkib (NVL-655)
AlectinibDRUGOral capsule of alectinib
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites155

Inclusion Criteria: 1. Histologically or cytologically confirmed locally advanced (not amenable for multimodality treatment) or metastatic Non-small Cell Lung Cancer (NSCLC) 2. Documented Anaplastic Lymphoma Kinase (ALK) rearrangement via testing of tissue or blood 3. No prior systemic anticancer t...

Countries:United StatesArgentinaAustraliaAustriaBelgiumBrazilCanadaChileCzechiaDenmarkFranceGermanyGreeceHong KongHungaryItalyJapanMalaysiaMexicoNetherlandsPolandPortugalSingaporeSouth KoreaSpainSwitzerlandTaiwanThailandUnited Kingdom
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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 2, 2026NCT06765109lastUpdatePostDate: changed
LOWJun 2, 2026NCT06765109lastUpdatePostDate: changed
LOWJun 2, 2026NCT06765109lastUpdatePostDate: changed
LOWMay 26, 2026NCT06765109primaryCompletionDate: changed
LOWMay 24, 2026NCT06765109studyFirstPostDate: changed