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Pharmacokinetic Similarity Between ABP 234 and Keytruda® (Pembrolizumab)

NCT06430866 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 163

Last updated 2026-04-01

No results posted yet for this study

Summary

The primary objective of this study is to demonstrate pharmacokinetic (PK) similarity ABP 234 with pembrolizumab.

Conditions

  • Early-stage Non-squamous Non-small Cell Lung Cancer (NSCLC)

Interventions

DRUG

ABP 234

Administered by intravenous (IV) injection.

DRUG

Pembrolizumab

Administered by IV injection.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-12
Primary Completion
2026-12-14
Completion
2026-12-14
FDA Drug
Yes

Countries

  • Argentina
  • Bulgaria
  • Chile
  • France
  • Georgia
  • Germany
  • Italy
  • Malaysia
  • Mexico
  • Philippines
  • Poland
  • Romania
  • Serbia
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06430866 on ClinicalTrials.gov