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ABP 234

Phase 3

Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer | 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-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment315

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)Unlock trial analytics
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 CancerUnlock trial analytics

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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Frequently asked questions about ABP 234

What is ABP 234 used for?

ABP 234 is an investigational small molecule being developed for early-stage non-squamous non-small cell lung cancer (NSCLC) and advanced or metastatic non-squamous NSCLC. It is being studied as a potential treatment for these conditions in clinical trials.

Who makes ABP 234?

ABP 234 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with non-squamous non-small cell lung cancer.

What phase is ABP 234 in?

ABP 234 is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 3 trials are designed to compare ABP 234 with Keytruda (pembrolizumab) in patients with non-squamous non-small cell lung cancer.

What clinical trials is ABP 234 in?

ABP 234 is being studied in two Phase 3 clinical trials. The first, NCT06311721, compares ABP 234 with Keytruda in 315 participants with advanced or metastatic non-squamous NSCLC. The second, NCT06430866, assesses pharmacokinetic similarity between ABP 234 and Keytruda in 163 participants with early-stage non-squamous NSCLC.

Is ABP 234 the same as Keytruda?

ABP 234 is not the same as Keytruda (pembrolizumab). It is being studied as a potential biosimilar to Keytruda, meaning it is designed to be similar in terms of safety and efficacy. Clinical trials are comparing ABP 234 directly with Keytruda to evaluate their similarity in treating non-squamous non-small cell lung cancer.