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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: May 6, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment163
FDA Designations
No designations recorded
Clinical trial landscape

ABP 234 · 2 trials · 2 indications

Phase 3 2
NCT06430866Pharmacokinetic Similarity Between ABP 234 and Keytruda® (Pembrolizumab)Early-stage Non-squamous Non-small Cell Lung Cancer (NSCLC)
ACTIVE NOT_RECRUITING163 Analytics
NCT06311721A Study to Compare ABP 234 and Keytruda® (Pembrolizumab) in Participants With Advanced or Metastatic Non-squamous Non-Small Cell Lung CancerAdvanced or Metastatic Non-squamous Non-Small Cell Lung Cancer
ACTIVE NOT_RECRUITING315 Analytics
PHASE3ACTIVE NOT_RECRUITING
Pharmacokinetic Similarity Between ABP 234 and Keytruda® (Pembrolizumab)
Early-stage Non-squamous Non-small Cell Lung Cancer (NSCLC)
NCT06430866163
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PHASE3ACTIVE NOT_RECRUITING
A Study to Compare ABP 234 and Keytruda® (Pembrolizumab) in Participants With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer
Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer
NCT06311721315
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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
Area under the serum concentration-time curve (AUC) from time 0 to 21 days (AUC21d) of ABP 234
21 days
AUC21d of pembrolizumab (US)
21 days
AUC21d of pembrolizumab (EU)
21 days
AUC at steady state between Week 16 and Week 19 (AUCtau_ss) of ABP 234
Week 16 through Week 19
AUCtau_ss of pembrolizumab (US)
Week 16 through Week 19
AUCtau_ss of pembrolizumab (EU)
Week 16 through Week 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.
Pembrolizumab (US)EXPERIMENTALPart 1: Participants will receive FDA-licensed pembrolizumab followed by pemetrexed administered with platinum-based chemotherapy (cisplatin or carboplatin). Part 2: Participants will receive FDA-licensed pembrolizumab followed by pemetrexed.
Pembrolizumab (EU)EXPERIMENTALPart 1: Participants will receive EU-approved pembrolizumab followed by pemetrexed administered with platinum-based chemotherapy (cisplatin or carboplatin). Part 2: Participants will receive EU-approved pembrolizumab followed by pemetrexed.
Interventions
NameTypeDescription
ABP 234DRUGAdministered by intravenous (IV) injection.
PembrolizumabDRUGAdministered by IV injection.
Pembrolizumab (US)DRUGIntravenous administration
Pembrolizumab (EU)DRUGIntravenous administration
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Eligibility Criteria
Age Range18 Years to 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)United StatesAustriaBrazilJapanPeruSouth AfricaUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06311721primaryCompletionDate: changed
MEDIUMMay 26, 2026NCT06430866Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 24, 2026NCT06430866studyFirstPostDate: changed
LOWMay 24, 2026NCT06311721studyFirstPostDate: changed