NCT06311721

A Study to Compare ABP 234 and Keytruda® (Pembrolizumab) in Participants With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer

A Randomized, Double-Blind Study to Compare Efficacy, Pharmacokinetics, Safety, and Immunogenicity Between ABP 234 and Keytruda® (Pembrolizumab) in Subjects With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 315 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to compare the efficacy of ABP 234 with the pembrolizumab reference product (Keytruda®).

Conditions

• Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	ABP 234	Intravenous administration
DRUG	Pembrolizumab (US)	Intravenous administration
DRUG	Pembrolizumab (EU)	Intravenous administration

Timeline

• Start date: 2024-09-09
• Primary completion: 2028-02-14
• Completion: 2028-05-29
• First posted: 2024-03-15
• Last updated: 2026-01-27

Locations

219 sites across 23 countries: United States, Argentina, Austria, Brazil, Bulgaria, Chile, France, Georgia, Germany, Italy, Japan, Malaysia, Peru, Philippines, Poland, Serbia, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study