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

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT06311721Tipo: INTERVENTIONALInicio: 9 de sept de 2024Fin estimado: 29 de may de 2028

Traducción no disponible, mostrando original

Resumen

The primary objective of this study is to compare the efficacy of ABP 234 with the pembrolizumab reference product (Keytruda®).

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 99 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

drug

ABP 234

Intravenous administration

drug

Pembrolizumab (US)

Intravenous administration

drug

Pembrolizumab (EU)

Intravenous administration

Ubicaciones

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

Patrocinadores

PrincipalAmgen

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