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Tarlatamab

Phase 3

Small Cell Lung Cancer (SCLC) | Small molecule | Oncology |Amgen Inc.|Last Updated: Mar 3, 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 Trials2
Total Enrollment761
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05740566Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung CancerPHASE3 ACTIVE NOT_RECRUITING 509May 31, 2023Mar 26, 2028Jan 5, 2026223 United States, Argentina +29
NCT06745323A Phase 2, Open-label, Randomized, Multicenter Study of Tarlatamab Dosing Regimens in Subjects With SCLCPHASE2 ACTIVE NOT_RECRUITING 252Feb 26, 2025Feb 9, 2029Mar 3, 202678 United States, Argentina +14
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Study Endpoints
Primary Endpoints
Overall Survival (OS)
From randomization up to minimum of death or primary completion DCO date 29 January 2025; median (min, max) time on the study was 8.6 (0.1, 18.5) months

OS was defined as time from randomization until death from any cause. Median overall survival was estimated using Kaplan-Meier method. 95% confidence intervals (CIs) were calculated using the Brookmeyer and Crowley method.

Proportion of participants with confirmed objective response to Tarlatamab
Approximately 52 Months
Proportion of participants with complete response to Tarlatamab
Approximately 52 Months
Proportion of participants with partial response to Tarlatamab
Approximately 52 Months
Secondary Endpoints
Progression Free Survival (PFS)
Up to approximately 4 years
Change From Baseline in Selected Functional Scales and Disease Symptom Items Included in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Up to approximately 4 years
Change From Baseline in Selected Disease Symptoms Included in the European Organization for Research and Treatment of Lung Cancer Quality of Life Questionnaire (EORTC-QLQ-LC13)
Up to approximately 4 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TarlatamabEXPERIMENTALParticipants will receive tarlatamab as an intravenous (IV) infusion.
Standard of CareACTIVE_COMPARATORParticipants will receive treatment per local standard of care (SOC).
Treatment Arm A: Dose 1 TarlatamabEXPERIMENTALParticipants will receive dose 1 of Tarlatamab by intravenous (IV) infusion during the treatment period.
Treatment Arm B: Dose 2 TarlatamabEXPERIMENTALParticipants will receive dose 2 of Tarlatamab by IV infusion during the treatment period.
Treatment Arm C: Dose 3 TarlatamabEXPERIMENTALParticipants will receive dose 3 of Tarlatamab by IV infusion during the treatment period.
Interventions
NameTypeDescription
TarlatamabDRUGTarlatamab will be administered as an IV infusion.
LurbinectedinDRUGLurbinectedin will be administered per local SOC.
TopotecanDRUGTopotecan will be administered per local SOC.
AmrubicinDRUGAmrubicin will be administered per local SOC.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites223

Inclusion Criteria: * Participant has provided informed consent prior to initiation of any study specific activities/procedures. * Age ≥ 18 years (or legal adult age within country, whichever is older) at the time of signing the informed consent. * Histologically or cytologically confirmed SCLC wit...

Countries:United StatesArgentinaAustraliaAustriaBelgiumBrazilCanadaChinaCzechiaDenmarkFranceGermanyGreeceHungaryIrelandIsraelItalyJapanMalaysiaMexicoNetherlandsPolandPortugalRomaniaSingaporeSouth KoreaSpainSwitzerlandTaiwanTurkey (Türkiye)United 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)
LOWMay 26, 2026NCT05740566primaryCompletionDate: changed
LOWMay 26, 2026NCT06745323primaryCompletionDate: changed
LOWMay 24, 2026NCT05740566studyFirstPostDate: changed
LOWMay 24, 2026NCT06745323studyFirstPostDate: changed