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

Running, not enrolling · Phase 3

Conditions studied: Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer

In brief

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

Key facts

Study ID

NCT06311721

Run by

Amgen

People needed

315

Starts

2024-09-09

Expected to finish

2028-04-24

Last updated by the study team

2026-05-06

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least 18 years of age.
• Histologically or cytologically confirmed stage IV non-squamous Non-Small Cell Lung Cancer (NSCLC).
• Participant has no prior systemic treatment for advanced disease.
• Measurable disease according to RECIST v1.1.
• Tumor tissue from the resected site of disease must be available for biomarker analyses in order to be randomized.
• Eastern Cooperative Oncology Group performance status score 0 or 1.
• 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
• Have a life expectancy of at least 3 months.

You may not qualify if…

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

Where it is running

• TOI Clinical Research — Cerritos, California, United States
• Cancer and Blood Specialty Clinic (CBSC) — Los Alamitos, California, United States
• Valkyrie Clinical Trials — Los Angeles, California, United States
• PIH Health Hospital — Whittier, California, United States
• Millennium Oncology - Hollywood — Hollywood, Florida, United States
• BRCR Medical Center Inc. — Tamarac, Florida, United States
• Accellacare Duly — Plainfield, Illinois, United States
• Accellacare of McFarland — Ames, Iowa, United States
• Detroit Clinical Research Center, PC — Farmington Hills, Michigan, United States
• North Shore Hematology-Oncology Associates P.C. d/b/a New York Cancer & Blood Specialists — Shirley, New York, United States
• Gabrail Cancer Center Research — Canton, Ohio, United States
• Millennium Research and Clinical Development, LLC — Houston, Texas, United States
• Texas Oncology, P.A — San Antonio, Texas, United States
• Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care — Wytheville, Virginia, United States
• Instituto de Investigaciones Clinicas Mar del Plata — Mar del Plata, Buenos Aires, Argentina
• Centro de Investigacion Pergamino SA — Pergamino, Buenos Aires, Argentina
• Fundacion ARS Medica — San Salvador de Jujuy, Jujuy Province, Argentina
• Sanatorio Britanico De Rosario — Rosario, Santa Fe Province, Argentina
• Hospital Provincial del Centenario — Rosario, Santa Fe Province, Argentina
• IONC - Instituto Oncologico de Cordoba — Córdoba, Argentina
• Klinikum Klagenfurt am Woerthersee — Klagenfurt, Austria
• Ordensklinikum Linz GmbH Elisabethinen — Linz, Austria
• CRIO - Centro Regional Integrado de Oncologia — Fortaleza, Ceará, Brazil
• OC Oncoclinicas Oncovida — Brasília, Destrito Federal, Brazil
• Precision NextGen Oncology and Research Center — Beverly Hills, California, United States

Full record on ClinicalTrials.gov

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