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ACTIVE NOT RECRUITING
NCT06311721
PHASE3

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

Sponsor: Amgen

View on ClinicalTrials.gov

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

DRUG

ABP 234

Intravenous administration

DRUG

Pembrolizumab (US)

Intravenous administration

DRUG

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

And 118 more locations on ClinicalTrials.gov