NCT06430866

Pharmacokinetic Similarity Between ABP 234 and Keytruda® (Pembrolizumab)

A Randomized, Double-blind Study to Compare the Pharmacokinetics Between ABP 234 and Keytruda® (Pembrolizumab) in Participants With Early-stage Non-squamous Non-small Cell Lung Cancer as Adjuvant Treatment Following Resection and Platinum-based Chemotherapy

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 163 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	ABP 234	Administered by intravenous (IV) injection.
DRUG	Pembrolizumab	Administered by IV injection.

Timeline

• Start date: 2024-09-12
• Primary completion: 2026-12-14
• Completion: 2026-12-14
• First posted: 2024-05-28
• Last updated: 2026-04-01

Locations

128 sites across 18 countries: Argentina, Bulgaria, Chile, France, Georgia, Germany, Italy, Malaysia, Mexico, Philippines, Poland, Romania, Serbia, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study