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

NCT06311721 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 315

Last updated 2026-05-06

No results posted yet for this study

Summary

The primary objective of this trial is to demonstrate pharmacokinetic (PK) similarity of ABP 234 compared with the pembrolizumab reference product (Keytruda®).

Conditions

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

Interventions

DRUG

ABP 234

Intravenous administration

DRUG

Pembrolizumab (US)

Intravenous administration

DRUG

Pembrolizumab (EU)

Intravenous administration

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
2024-09-09
Primary Completion
2028-01-10
Completion
2028-04-24
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

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 NCT06311721 on ClinicalTrials.gov