A Study to Compare ABP 234 and Keytruda® (Pembrolizumab) in Participants With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer
The primary objective of this trial is to demonstrate pharmacokinetic (PK) similarity of ABP 234 compared with the pembrolizumab reference product (Keytruda®).
Checked against the public recordLast updated May 6, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Amgen
- Interventions being studied
- Drug: ABP 234; Drug: Pembrolizumab (US); Drug: Pembrolizumab (EU)
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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: 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Precision NextGen Oncology and Research CenterBeverly Hills, California
- TOI Clinical ResearchCerritos, California
- Cancer and Blood Specialty Clinic (CBSC)Los Alamitos, California
- Valkyrie Clinical TrialsLos Angeles, California
- PIH Health HospitalWhittier, California
- Millennium Oncology - HollywoodHollywood, Florida
- BRCR Medical Center Inc.Tamarac, Florida
- Accellacare DulyPlainfield, Illinois
- Accellacare of McFarlandAmes, Iowa
- Detroit Clinical Research Center, PCFarmington Hills, Michigan
- North Shore Hematology-Oncology Associates P.C. d/b/a New York Cancer & Blood SpecialistsShirley, New York
- Gabrail Cancer Center ResearchCanton, Ohio
Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 6, 2026. Always confirm current availability with the study team.