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Clinical Trials in the UK / NCT06311721
Active, not recruiting Phase 3

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

NCT06311721 · tracked via the Priya Life Science UK tracker
Sponsor
Amgen
Phase
Phase 3
Started
2024-09-09
Last updated
2026-05-06

Condition(s) studied

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

Investigational drug(s) / intervention(s)

ABP 234Pembrolizumab (US)Pembrolizumab (EU)

ABP 234: Intravenous administration

Pembrolizumab (US): Intravenous administration

Pembrolizumab (EU): Intravenous administration

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (218)

FacilityCityRegionStatus
Precision NextGen Oncology and Research Center Beverly Hills California
TOI Clinical Research Cerritos California
Cancer and Blood Specialty Clinic (CBSC) Los Alamitos California
Valkyrie Clinical Trials Los Angeles California
PIH Health Hospital Whittier California
Millennium Oncology - Hollywood Hollywood Florida
BRCR Medical Center Inc. Tamarac Florida
Accellacare Duly Plainfield Illinois
Accellacare of McFarland Ames Iowa
Detroit Clinical Research Center, PC Farmington Hills Michigan
North Shore Hematology-Oncology Associates P.C. d/b/a New York Cancer & Blood Specialists Shirley New York
Gabrail Cancer Center Research Canton Ohio
Millennium Research and Clinical Development, LLC Houston Texas
Texas Oncology, P.A San Antonio Texas
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care Wytheville Virginia
Instituto de Investigaciones Clinicas Mar del Plata Mar del Plata Buenos Aires
Centro de Investigacion Pergamino SA Pergamino Buenos Aires
Fundacion ARS Medica San Salvador de Jujuy Jujuy Province
Sanatorio Britanico De Rosario Rosario Santa Fe Province
Hospital Provincial del Centenario Rosario Santa Fe Province
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
OC Oncoclinicas Oncovida Brasília Destrito Federal
Centro de Pesquisas Clinicas em Oncologia (CPCO)/HECI Cachoeiro de Itapemirim Espírito Santo
Associacao Feminina de Educacao e Combate ao Cancer(AFECC) - Hospital Santa Rita Vitória Espírito Santo
Hospital Santa Izabel, Santa Casa de Misericordia da Bahia Salvador Estado de Bahia
Cetus Oncologia S.A. Unidade Belo Horizonte Belo Horizonte Minas Gerais
Nucleo de Ensino Pesquisa e Inovacao Mario Penna Belo Horizonte Minas Gerais
Fundacao Sao Francisco Xavier - Hospital Marcio Cunha (HMC) - Unidade I Ipatinga Minas Gerais
Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner Curitiba Paraná
Instituto de Cancer de Londrina - Hospital do Cancer de Londrina - HCL Londrina Paraná
Liga Contra o Cancer Natal Rio Grande do Norte
Hospital Tacchini Bento Gonçalves Rio Grande do Sul
Oncosite Centro De Pesquisa Clinica Em Oncologia Ijuí Rio Grande do Sul
Hospital Bruno Born Lajeado Rio Grande do Sul
Hospital da Cidade de Passo Fundo - HCPF Passo Fundo Rio Grande do Sul
Unidade de Pesquisa Clinica em Oncologia Ltda (UPCO) (Clinica Lacks) Pelotas Rio Grande do Sul
Centro de Pesquisa em Oncologia - Hospital Sao Lucas da PUC Rio Grande do Sul Porto Alegre Rio Grande do Sul

+ 178 more sites — see the full list on the official registry below.

More Amgen trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06311721 on ClinicalTrials.gov ↗ ← All trials in the UK