Last updated 5 days ago
A Study to Compare ABP 234 and Keytruda® (Pembrolizumab) in Participants With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer
927 patients around the world
Available in Chile, United States, Argentina, Peru
Amgen
12Research sites
927Patients around the world
This study is for people with
Lung cancer
Non-small cell lung carcinoma
Requirements for the patient
To 99 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
Instituto de Investigaciones Clínicas Mar del Plata
Recruiting
Hospital Provincial del Centenario - Rosario, Santa Fe
Recruiting
Centro de Investigación Pergamino SA
Recruiting
Fundación Ars Médica - San Salvador de Jujuy
Recruiting
Instituto Oncológico de Córdoba IONC - Fundación Richardet Longo
Recruiting
Centro Oncológico y Tratamiento Oncología - CDIEM
Recruiting
Centro de Investigaciones Clínicas Viña Del Mar
Recruiting
Icegclinic Research & Care
Recruiting
Clínica San Antonio
Recruiting
Centro Especializado De Enfermedades Neoplásicas
Recruiting
StudyMARYGOLD
SponsorAmgen
Study typeInterventional
Conditions
Non-small cell lung carcinoma
Requirements
To 99 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06311721
