A Study to Compare ABP 234 and Keytruda® (Pembrolizumab) in Participants With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer
Phase 3 – large-scale trial before approval
Conditions:
Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer
Sponsor: Amgen
trial.available_in:
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Overview
The primary objective of this study is to compare the efficacy of ABP 234 with the pembrolizumab reference product (Keytruda®).
Who can participate
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.
Interventions
ABP 234
DRUG
Pembrolizumab (US)
DRUG
Pembrolizumab (EU)
DRUG
Locations
227
Argentina (6)
IONC - Instituto Oncologico de Cordoba
Córdoba
Instituto de Investigaciones Clinicas Mar del Plata
Mar del Plata , Buenos Aires
Centro de Investigacion Pergamino SA
Pergamino , Buenos Aires
Sanatorio Britanico De Rosario
Rosario , Santa Fe Province
Hospital Provincial del Centenario
Rosario , Santa Fe Province
Fundacion ARS Medica
San Salvador de Jujuy , Jujuy Province
Austria (2)
Klinikum Klagenfurt am Woerthersee
Klagenfurt
Ordensklinikum Linz GmbH Elisabethinen
Linz
Brazil (37)
Fundacao Pio XII - Hospital de Cancer de Barretos
Barretos , São Paulo
Cetus Oncologia S.A. Unidade Belo Horizonte
Belo Horizonte , Minas Gerais
Nucleo de Ensino Pesquisa e Inovacao Mario Penna
Belo Horizonte , Minas Gerais
Hospital Tacchini
Bento Gonçalves , Rio Grande do Sul
OC Oncoclinicas Oncovida
Brasília , Destrito Federal
Centro de Pesquisas Clinicas em Oncologia (CPCO)/HECI
Cachoeiro de Itapemirim , Espírito Santo
Centro de Pesquisa Sao Lucas
Campinas , São Paulo
Hospital Nossa Senhora das Gracas
Canoas
Centro de Oncologia de Santa Catarina Ltda / Supera Oncologia
Chapecó , Santa Catarina
Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner
Curitiba , Paraná
CIONC - Centro Integrado de Oncologia de Curitiba
Curitiba
CEPEN Centro de Pesquisa e Ensino em Saude de Santa Catarina
Florianópolis , Santa Catarina
CRIO - Centro Regional Integrado de Oncologia
Fortaleza , Ceará
Oncosite Centro De Pesquisa Clinica Em Oncologia
Ijuí , Rio Grande do Sul
Fundacao Sao Francisco Xavier - Hospital Marcio Cunha (HMC) - Unidade I
Ipatinga , Minas Gerais
Centro de Ensino e Pesquisa Reichow
Jardim Blumenau , Santa Catarina
Instituto Joinvillense de Hematologia e Oncologia SS Ltda - Clinica de Hematologia e Oncologia
Joinville , Santa Catarina
Hospital Bruno Born
Lajeado , Rio Grande do Sul
Instituto de Cancer de Londrina - Hospital do Cancer de Londrina - HCL
Londrina , Paraná
Centro Oncologico Mogi das Cruzes
Mogi das Cruzes , São Paulo
Liga Contra o Cancer
Natal , Rio Grande do Norte
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
Centro Integrado de Pesquisa em Oncologia - Hospital Nossa Senhora da Conceio
Porto Alegre
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
Instituto Ribeiraopretano de Combate ao Cancer (IRPCc) - IRPCC
Ribeirão Preto , São Paulo
Instituto Nacional de Cancer (INCA)
Rio de Janeiro
Instituto Americas - Ensino, Pesquisa e Inovacao
Rio de Janeiro
Oncoclinicas Rio de Janeiro S.A (Centro de Tratamento de Tumores Botafogo)
Rio de Janeiro - RJ
Hospital Santa Izabel, Santa Casa de Misericordia da Bahia
Salvador , Estado de Bahia
Instituto D'Or de Pesquisa e Ensino - Hospital Sao Rafael
Salvador
Faculdade de Medicina do ABC - Centro de Estudos e Pesqulsas de Hematologia e Oncologia
Santo André , São Paulo
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
Hospital Alemao Oswaldo Cruz (HAOC)
São Paulo
Instituto Brasileiro de Controle do Cancer - IBCC Oncologia
São Paulo
Associacao Feminina de Educacao e Combate ao Cancer(AFECC) - Hospital Santa Rita
Vitória , Espírito Santo
Bulgaria (3)
MHAT Dobrich AD
Dobrich
University Multi-Profile Hospital for Active Treatment (UMHAT) St. Ivan Rilski
Sofia , Sofia-Grad
University Multiprofile Hospital for Active Treatment Sofiamed
Sofia
Chile (7)
CDIEM - Centro de Investigacion y Especialidades Medicas
Providencia , Santiago Metropolitan
Centro de Oncologa de Precisin
Region Metropolitana , Santiago Metropolitan
Clinica Santa Maria
Santiago , Santiago Metropolitan
K2 Oncology
Santiago
Icegclinic Research and Care
Santiago
Oncocentro
Viña del Mar , Valparaiso
Centro de Investigaciones Clinicas Vina del Mar Ltda.
Viña del Mar , Valparaiso
France (8)
Centre Hospitalier Universitaire de Bordeaux - Hopital Saint - Andre
Bordeaux
Centre Hospitalier Universitaire (CHU) De Limoges Hopital Dupuytren
Limoges
Hopital Europeen Marseille
Marseille
Clinique Clementville-Gcs Centre De Cancerologie Du Grand Montpellier
Montpellier
Centre Hospitalier Universitaire de Nimes (CHU) - Hopital Universitaire Caremeau
Nîmes
Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (C.H.I.T.S) - Hospital Font-Pre
Toulon
Clinique Teissier
Valenciennes
Hopital Robert Schuman
Vantoux
Georgia (6)
High Technology Hospital Medcenter LTD
Batumi
Israel-Georgian Medical Research Clinic Healthycore
Tbilisi
LLC Todua Clinic
Tbilisi
TIM -Tbilisi Institute of Medicine
Tbilisi
New Hospitals
Tbilisi
Medulla - Clinics And Medical Centers
Tbilisi
Germany (4)
Evang. Kliniken Essen Mitte GmbH
Essen
Studienzentrum Aschaffenburg
Hösbach
Haematologie, Onkologie und Palliativmedizin, Tagesklinik Landshut
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