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ABP 234

Phase 3

Early-stage Non-squamous Non-small Cell Lung Cancer (NSCLC) | Small molecule | Oncology |Amgen Inc.|Last Updated: Apr 1, 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
RandomizedDouble-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment163
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06430866Pharmacokinetic Similarity Between ABP 234 and Keytruda® (Pembrolizumab)PHASE3 ACTIVE NOT_RECRUITING 163 — — Sep 12, 2024Dec 14, 2026Apr 1, 2026128 Argentina, Bulgaria +16
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Study Endpoints
Primary Endpoints
Area Under the Serum Concentration-time Curve (AUC) From Time 0 to 21 Days (AUC21d) Following the First Dose
21 days
AUC at Steady State Between Week 16 and Week 19 (AUCtau_ss)
Weeks 16-19
Secondary Endpoints
Maximum Observed Serum Concentration (Cmax) Following the First Dose (Cmax_dose1)
Up to 65 weeks
Time to Maximum Serum Concentration (Tmax) Following the First Dose (Tmax_dose1)
Up to 65 weeks
Cmax at Steady State (Cmax_ss)
Weeks 16-19
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ABP 234EXPERIMENTALParticipants will receive ABP 234 every 3 weeks (Q3W) for up to 12 months.
PembrolizumabACTIVE_COMPARATORParticipants will receive pembrolizumab Q3W for up to 12 months.
Interventions
NameTypeDescription
ABP 234DRUGAdministered by intravenous (IV) injection.
PembrolizumabDRUGAdministered by IV injection.
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Eligibility Criteria
Age Range18 Years — 99 Years
SexALL
Healthy VolunteersNo
Study Sites128

Inclusion Criteria: * Males and females ≥ 18 years of age. * Pathological diagnosis of non-squamous NSCLC. * Stage IB (T2 ≥ 4 cm), II, or IIIA NSCLC after complete surgical resection and received platinum-based chemotherapy. * For programmed death-ligand 1 (PD-L1) testing, tumor tissue from the res...

Countries:ArgentinaBulgariaChileFranceGeorgiaGermanyItalyMalaysiaMexicoPhilippinesPolandRomaniaSerbiaSouth KoreaSpainTaiwanThailandTurkey (Türkiye)
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT06430866Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 24, 2026NCT06430866studyFirstPostDate: changed