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A Study to Compare ABP 234 and Keytruda® (Pembrolizumab) in Participants With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer
Sponsor: Amgen
Summary
The primary objective of this trial is to demonstrate pharmacokinetic (PK) similarity of ABP 234 compared with the pembrolizumab reference product (Keytruda®).
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
315
Start Date
2024-09-09
Completion Date
2028-04-24
Last Updated
2026-05-06
Healthy Volunteers
No
Interventions
ABP 234
Intravenous administration
Pembrolizumab (US)
Intravenous administration
Pembrolizumab (EU)
Intravenous administration
Locations (218)
Precision NextGen Oncology and Research Center
Beverly Hills, California, United States
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
Centro de Pesquisas Clinicas em Oncologia (CPCO)/HECI
Cachoeiro de Itapemirim, Espírito Santo, Brazil
Associacao Feminina de Educacao e Combate ao Cancer(AFECC) - Hospital Santa Rita
Vitória, Espírito Santo, Brazil
Hospital Santa Izabel, Santa Casa de Misericordia da Bahia
Salvador, Estado de Bahia, Brazil
Cetus Oncologia S.A. Unidade Belo Horizonte
Belo Horizonte, Minas Gerais, Brazil
Nucleo de Ensino Pesquisa e Inovacao Mario Penna
Belo Horizonte, Minas Gerais, Brazil
Fundacao Sao Francisco Xavier - Hospital Marcio Cunha (HMC) - Unidade I
Ipatinga, Minas Gerais, Brazil
Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner
Curitiba, Paraná, Brazil
Instituto de Cancer de Londrina - Hospital do Cancer de Londrina - HCL
Londrina, Paraná, Brazil
Liga Contra o Cancer
Natal, Rio Grande do Norte, Brazil
Hospital Tacchini
Bento Gonçalves, Rio Grande do Sul, Brazil
Oncosite Centro De Pesquisa Clinica Em Oncologia
Ijuí, Rio Grande do Sul, Brazil
Hospital Bruno Born
Lajeado, Rio Grande do Sul, Brazil
Hospital da Cidade de Passo Fundo - HCPF
Passo Fundo, Rio Grande do Sul, Brazil
Unidade de Pesquisa Clinica em Oncologia Ltda (UPCO) (Clinica Lacks)
Pelotas, Rio Grande do Sul, Brazil
Centro de Pesquisa em Oncologia - Hospital Sao Lucas da PUC Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil
Associacao dos Functionarios Publicos do Estado do Rio Grande do Sul - Hospital Ernesto Dornelles (H
Porto Alegre Rio Grande Do Sul, Rio Grande do Sul, Brazil
Centro de Oncologia de Santa Catarina Ltda / Supera Oncologia
Chapecó, Santa Catarina, Brazil
CEPEN Centro de Pesquisa e Ensino em Saude de Santa Catarina
Florianópolis, Santa Catarina, Brazil
Instituto Joinvillense de Hematologia e Oncologia SS Ltda - Clinica de Hematologia e Oncologia
Joinville, Santa Catarina, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos
Barretos, São Paulo, Brazil
Centro de Pesquisa Sao Lucas
Campinas, São Paulo, Brazil
Centro Oncologico Mogi das Cruzes
Mogi das Cruzes, São Paulo, Brazil
Instituto Ribeiraopretano de Combate ao Cancer (IRPCc) - IRPCC
Ribeirão Preto, São Paulo, Brazil
Faculdade de Medicina do ABC - Centro de Estudos e Pesqulsas de Hematologia e Oncologia
Santo André, São Paulo, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base de Sao Jose do R
São José do Rio Preto, São Paulo, Brazil
Hospital Nossa Senhora das Gracas
Canoas, Brazil
CIONC - Centro Integrado de Oncologia de Curitiba
Curitiba, Brazil
Centro Integrado de Pesquisa em Oncologia - Hospital Nossa Senhora da Conceio
Porto Alegre, Brazil
Instituto Nacional de Cancer (INCA)
Rio de Janeiro, Brazil
Instituto Americas - Ensino, Pesquisa e Inovacao
Rio de Janeiro, Brazil
Oncoclinicas Rio de Janeiro S.A (Centro de Tratamento de Tumores Botafogo)
Rio de Janeiro - RJ, Brazil
Instituto D'Or de Pesquisa e Ensino - Hospital Sao Rafael
Salvador, Brazil
Hospital Alemao Oswaldo Cruz (HAOC)
São Paulo, Brazil
Instituto Brasileiro de Controle do Cancer - IBCC Oncologia
São Paulo, Brazil
University Multi-Profile Hospital for Active Treatment (UMHAT) St. Ivan Rilski
Sofia, Sofia-Grad, Bulgaria
MHAT Dobrich AD
Dobrich, Bulgaria
University Multiprofile Hospital for Active Treatment Sofiamed
Sofia, Bulgaria
CDIEM - Centro de Investigacion y Especialidades Medicas
Providencia, Santiago Metropolitan, Chile
Centro de Oncologa de Precisin
Region Metropolitana, Santiago Metropolitan, Chile
Clinica Santa Maria
Santiago, Santiago Metropolitan, Chile
Oncocentro APYS
Viña del Mar, Valparaiso, Chile
Centro de Investigaciones Clinicas Vina del Mar Ltda.
Viña del Mar, Valparaiso, Chile
K2 Oncology
Santiago, Chile
Icegclinic Research and Care
Santiago, Chile
Centre Hospitalier Universitaire de Bordeaux - Hopital Saint - Andre
Bordeaux, France
Centre Hospitalier Universitaire (CHU) De Limoges Hopital Dupuytren
Limoges, France
Hopital Europeen Marseille
Marseille, France
Clinique Clementville-Gcs Centre De Cancerologie Du Grand Montpellier
Montpellier, France
Centre Hospitalier Universitaire de Nimes (CHU) - Hopital Universitaire Caremeau
Nîmes, France
Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (C.H.I.T.S) - Hospital Font-Pre
Toulon, France
Clinique Teissier
Valenciennes, France
Hopital Robert Schuman
Vantoux, France
High Technology Hospital Medcenter LTD
Batumi, Georgia
Israel-Georgian Medical Research Clinic Healthycore
Tbilisi, Georgia
LLC Todua Clinic
Tbilisi, Georgia
TIM -Tbilisi Institute of Medicine
Tbilisi, Georgia
New Hospitals
Tbilisi, Georgia
Medulla - Clinics And Medical Centers
Tbilisi, Georgia
Evang. Kliniken Essen Mitte GmbH
Essen, Germany
Studienzentrum Aschaffenburg
Hösbach, Germany
Haematologie, Onkologie und Palliativmedizin, Tagesklinik Landshut
Landshut, Germany
FEK - Friedrich-Ebert-Krankenhaus Neumuenster GmbH
Neumünster, Germany
Azienda Ospedaliero - Universitaria di Ferrara
Cona, Italy
Azienda Socio Sanitaria Territoriale di Cremona
Cremona, Italy
Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico Di Milano
Milan, Italy
UOC Oncoematologia AOU Luigi Vanvitelli
Naples, Italy
ASL Napoli 1 Centro-Ospedale del Mare
Naples, Italy
AUSL Della Romagna - Ospedale S.Maria delle Croci
Ravenna, Italy
S.C. Oncologia Medica-Presidio Ospedaliero Sondrio
Sondrio, Italy
Azienda Ospedaliera Santa Maria Terni
Terni, Italy
Japan Community Healthcare Organization Chukyo Hospital
Nagoya, Aichi-ken, Japan
Funabashi Municipal Medical Center
Funabashi-shi, Chiba, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, Japan
Aso Iizuka Hospital
Iizuka-shi, Fukuoka, Japan
Japanese Red Cross Maebashi Hospital
Maebashi, Gunma, Japan