Comparison between ABP 234 and Keytruda (Pembrolizumab)

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

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2061240025

Enrollment

Registered

2024-06-18

Start date

2024-09-09

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Drug: ABP 234* Drug: Pembrolizumab (US)* Drug: Pembrolizumab (EU)* * Intravenous administration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. At least 18 years of age. 2. Histologically or cytologically confirmed stage IV non-squamous Non-Small Cell Lung Cancer (NSCLC). 3. Participant has no prior systemic treatment for advanced disease. 4. Measurable disease according to RECIST v1.1. 5. Tumor tissue from the resected site of disease must be available for biomarker analyses in order to be randomized. 6. Eastern Cooperative Oncology Group performance status score 0 or 1. 7. Epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), and c-ros oncogene 1, receptor tyrosine kinase of the insulin receptor family (ROS-1) negative 8. Have a life expectancy of at least 3 months.

Exclusion criteria

Exclusion criteria: 1. Small cell lung cancer (SCLC) or mixed SCLC/NSCLC histology or squamous cell carcinoma. 2. Participant has active central nervous system metastases not previously treated. 3. Participant has active or known immune-mediated disorders. 4. Participant has received prior systemic cytotoxic chemotherapy, immunotherapy (including PD-1/PD-L1), anti-neoplastic biological therapy, or targeted therapy for advanced/metastatic disease. 5. Known hypersensitivity to monoclonal antibodies or to any of the excipients of the study drug, or to any component of cisplatin, carboplatin, or pemetrexed.

Design outcomes

Primary

Measure	Time frame
- Area under the serum concentration-time curve (AUC) from time 0 to 21 days (AUC21d) of ABP 234 - AUC at steady state between Week 16 and Week 19 (AUCtau_ss) of ABP 234	—

Countries

Argentina, Austria, Brazil, Bulgaria, Chile, France, Georgia, Germany, Italy, Japan, Malaysia, Peru, Philippines, Poland, Romania, Serbia, S Korea, South Africa, Spain, Taiwan, Thailand, the United Kingdom., Turkey, US

Contacts

Public ContactClinical trial contact

ICON Clinical Research GK

Japan-Chiken@iconplc.com+81-6-4560-2001

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026