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
Status: Recruiting
Location: See all (214) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The primary objective of this study is to compare the efficacy of ABP 234 with the pembrolizumab reference product (Keytruda®).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
Precision NextGen Oncology and Research Center
RECRUITING
Beverly Hills
TOI Clinical Research
RECRUITING
Cerritos
Cancer and Blood Specialty Clinic (CBSC)
RECRUITING
Los Alamitos
Valkyrie Clinical Trials
TERMINATED
Los Angeles
PIH Health Hospital
RECRUITING
Whittier
Florida
Millennium Oncology - Hollywood
RECRUITING
Hollywood
BRCR Medical Center Inc.
RECRUITING
Tamarac
Iowa
Accellacare of McFarland
RECRUITING
Ames
Illinois
Accellacare Duly
COMPLETED
Plainfield
Michigan
Detroit Clinical Research Center, PC
RECRUITING
Farmington Hills
New York
North Shore Hematology-Oncology Associates P.C. d/b/a New York Cancer & Blood Specialists
RECRUITING
Shirley
Ohio
Gabrail Cancer Center Research
RECRUITING
Canton
Texas
Millennium Research and Clinical Development, LLC
COMPLETED
Houston
Texas Oncology, P.A
RECRUITING
San Antonio
Virginia
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
RECRUITING
Wytheville
Other Locations
Argentina
IONC - Instituto Oncologico de Cordoba
RECRUITING
Córdoba
Instituto de Investigaciones Clinicas Mar del Plata
RECRUITING
Mar Del Plata
Centro de Investigacion Pregamino SA
RECRUITING
Pergamino
Hospital Provincial del Centenario
RECRUITING
Rosario
Sanatorio Britanico De Rosario
RECRUITING
Rosario
Fundacion ARS Medica
RECRUITING
San Salvador De Jujuy
Austria
Klinikum Klagenfurt am Woerthersee
RECRUITING
Klagenfurt
Ordensklinikum Linz GmbH Elisabethinen
RECRUITING
Linz
Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos
RECRUITING
Barretos
Cetus Oncologia S.A. Unidade Belo Horizonte
RECRUITING
Belo Horizonte
Nucleo de Ensino Pesquisa e Inovacao Mario Penna
RECRUITING
Belo Horizonte
Hospital Tacchini
RECRUITING
Bento Gonçalves
OC Oncoclinicas Oncovida
RECRUITING
Brasília
Centro de Pesquisas Clinicas em Oncologia (CPCO)/HECI
RECRUITING
Cachoeiro De Itapemirim
Centro de Pesquisa Sao Lucas
RECRUITING
Campinas
Hospital Nossa Senhora das Gracas
COMPLETED
Canoas
Centro de Oncologia de Santa Catarina Ltda / Supera Oncologia
RECRUITING
Chapecó
CIONC - Centro Integrado de Oncologia de Curitiba
RECRUITING
Curitiba
Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner
RECRUITING
Curitiba
CEPEN Centro de Pesquisa e Ensino em Saude de Santa Catarina
RECRUITING
Florianópolis
CRIO - Centro Regional Integrado de Oncologia
RECRUITING
Fortaleza
Oncosite Centro De Pesquisa Clinica Em Oncologia
RECRUITING
Ijuí
Fundacao Sao Francisco Xavier - Hospital Marcio Cunha (HMC) - Unidade I
RECRUITING
Ipatinga
Instituto Joinvillense de Hematologia e Oncologia SS Ltda - Clinica de Hematologia e Oncologia
RECRUITING
Joinville
Hospital Bruno Born
RECRUITING
Lajeado
Instituto de Cancer de Londrina - Hospital do Cancer de Londrina - HCL
RECRUITING
Londrina
Centro Oncologico Mogi das Cruzes
RECRUITING
Mogi Das Cruzes
Liga Contra o Cancer
RECRUITING
Natal
Hospital da Cidade de Passo Fundo - HCPF
RECRUITING
Passo Fundo
Unidade de Pesquisa Clinica em Oncologia Ltda (UPCO) (Clinica Lacks)
RECRUITING
Pelotas
Centro de Pesquisa em Oncologia - Hospital Sao Lucas da PUC Rio Grande do Sul
RECRUITING
Porto Alegre
Centro Integrado de Pesquisa em Oncologia - Hospital Nossa Senhora da Conceio
RECRUITING
Porto Alegre
Associacao dos Functionarios Publicos do Estado do Rio Grande do Sul - Hospital Ernesto Dornelles (H
RECRUITING
Porto Alegre Rio Grande Do Sul
Instituto Ribeiraopretano de Combate ao Cancer (IRPCc) - IRPCC
RECRUITING
Ribeirão Preto
Instituto Americas - Ensino, Pesquisa e Inovacao
RECRUITING
Rio De Janeiro
Instituto Nacional de Cancer (INCA)
RECRUITING
Rio De Janeiro
Oncoclinicas Rio de Janeiro S.A (Centro de Tratamento de Tumores Botafogo)
RECRUITING
Rio De Janeiro - Rj
Hospital Santa Izabel, Santa Casa de Misericordia da Bahia
RECRUITING
Salvador
Hospital Sao Rafael
RECRUITING
Salvador
Faculdade de Medicina do ABC - Centro de Estudos e Pesqulsas de Hematologia e Oncologia
RECRUITING
Santo André
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base de Sao Jose do R
RECRUITING
São José Do Rio Preto
Hospital Alemao Oswaldo Cruz (HAOC)
RECRUITING
São Paulo
Instituto Brasileiro de Controle do Cancer - IBCC Oncologia
RECRUITING
São Paulo
Associacao Feminina de Educacao e Combate ao Cancer(AFECC) - Hospital Santa Rita
RECRUITING
Vitória
Bulgaria
MHAT Dobrich AD
RECRUITING
Dobrich
University Multi-Profile Hospital for Active Treatment (UMHAT) St. Ivan Rilski
RECRUITING
Sofia
University Multiprofile Hospital for Active Treatment Sofiamed
RECRUITING
Sofia
Chile
Cdiem
RECRUITING
Providencia
Centro de Oncologa de Precisin
RECRUITING
Region Metropolitana
Clinica Santa Maria
RECRUITING
Santiago
Icegclinic Research and Care
RECRUITING
Santiago
K2 Oncology
RECRUITING
Santiago
Centro de Investigaciones Clinicas Vina del Mar Ltda.
RECRUITING
Viña Del Mar
Oncocentro
RECRUITING
Viña Del Mar
France
Centre Hospitalier Universitaire de Bordeaux - Hopital Saint - Andre
RECRUITING
Bordeaux
Centre Hospitalier Universitaire (CHU) De Limoges Hopital Dupuytren
RECRUITING
Limoges
Hopital Europeen Marseille
RECRUITING
Marseille
Clinique Clementville-Gcs Centre De Cancerologie Du Grand Montpellier
RECRUITING
Montpellier
Centre Hospitalier Universitaire de Nimes (CHU) - Hopital Universitaire Caremeau
RECRUITING
Nîmes
Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (C.H.I.T.S) - Hospital Font-Pre
RECRUITING
Toulon
Clinique Teissier
RECRUITING
Valenciennes
Hopital Robert Schuman
RECRUITING
Vantoux
Georgia
High Technology Hospital Medcenter LTD
RECRUITING
Batumi
Israel-Georgian Medical Research Clinic Healthycore
RECRUITING
Tbilisi
LLC Todua Clinic
RECRUITING
Tbilisi
Medulla - Clinics And Medical Centers
RECRUITING
Tbilisi
New Hospitals
RECRUITING
Tbilisi
TIM -Tbilisi Institute of Medicine
RECRUITING
Tbilisi
Germany
Evang. Kliniken Essen Mitte GmbH
RECRUITING
Essen
Studienzentrum Aschaffenburg
RECRUITING
Hã¶sbach
Haematologie, Onkologie und Palliativmedizin, Tagesklinik Landshut
RECRUITING
Landshut
FEK - Friedrich-Ebert-Krankenhaus Neumuenster GmbH
RECRUITING
Neumünster
Italy
Azienda Ospedaliera Universitaria Di Ferrara
RECRUITING
Cona
Azienda Socio Sanitaria Territoriale di Cremona
RECRUITING
Cremona
Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico Di Milano
RECRUITING
Milan
UOC Oncoematologia AOU Luigi Vanvitelli
RECRUITING
Naples
ASL Napoli 1 Centro-Ospedale del Mare
RECRUITING
Napoli
AUSL Della Romagna - Ospedale S.Maria delle Croci
RECRUITING
Ravenna
S.C. Oncologia Medica-Presidio Ospedaliero Sondrio
RECRUITING
Sondrio
Azienda Ospedaliera Santa Maria Terni
RECRUITING
Terni
Japan
Hyogo Prefectural Amagasaki General Medical Center
RECRUITING
Amagasaki
Asahikawa Medical University Hospital
RECRUITING
Asahikawa
Kyushu University Hospital
RECRUITING
Fukuoka
Chugoku Central Hospital
RECRUITING
Fukuyama
Funabashi Municipal Medical Center
RECRUITING
Funabashi-shi
Hamamatsu Medical Center
RECRUITING
Hamamatsu
Seirei Hamamatsu General Hospital
RECRUITING
Hamamatsu
Hiroshima Prefectural Hospital
RECRUITING
Hiroshima
Aso Iizuka Hospital
RECRUITING
Iizuka-shi
Kawaguchi Municipal Medical Center
RECRUITING
Kawaguchi-shi
Nippon Medical School Musashikosugi Hospital
RECRUITING
Kawasaki-shi
Social Welfare Organization Imperial Gift Foundation, Inc. Saiseikai Kumamoto Hospital
RECRUITING
Kumamoto
Japanese Red Cross Maebashi Hospital
RECRUITING
Maebashi
Shinshu University Hospital
RECRUITING
Matsumoto
Miyazaki Prefectural Miyazaki Hospital
RECRUITING
Miyazaki
Japan Community Healthcare Organization Chukyo Hospital
RECRUITING
Nagoya
Ome Medical Center
RECRUITING
Ome-shi
Osaki Citizen Hospital
RECRUITING
Ōsaki
NHO Kinki Chuo Chest Medical Center
RECRUITING
Sakai
Yokohama City University Hospital
RECRUITING
Yokohama
Yokosuka Kyosai Hospital
RECRUITING
Yokosuka
Malaysia
Hospital Sultanah Bahiyah
RECRUITING
Alor Star
Hospital Canselor Tuanku Muhriz UKM
RECRUITING
Cheras
Raja Perempuan Zainab II Hospital
RECRUITING
Kota Bharu
University of Malaya Medical Centre
RECRUITING
Kuala Lumpur
Sarawak General Hospital
RECRUITING
Kuching
Peru
Centro Medico Monte Carmelo
RECRUITING
Arequipa
Hospital IV - Alberto Sabogal Sologuren Red Asistencial Sabogal
RECRUITING
Bellavista
Hospital III Goyeneche
RECRUITING
Cercado
Hospital de Apoyo Maria Auxiliadora
RECRUITING
Lima
Instituto Nacional De Enfermedades Neoplasicas
RECRUITING
Surquillo
Clnica San Antonio
RECRUITING
Trujillo
Philippines
Riverside Medical Center Inc
RECRUITING
Bacolod City
Cebu Doctors University Hospital
RECRUITING
Cebu City
Chong Hua Hospital
RECRUITING
Cebu City
Perpetual Succour Hospital
RECRUITING
Cebu City
Davao Doctors Hospital
RECRUITING
Davao City
West Visayas State University Medical Center
RECRUITING
Iloilo City
Philippine General Hospital
RECRUITING
Manila
Asian Hospital And Medical Center
RECRUITING
Muntinlupa
Veterans Memorial Medical Center
RECRUITING
Quezon City
Poland
Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy
RECRUITING
Bydgoszcz
Instytut MSF Sp. z o.o.
COMPLETED
Lodz
NZOZ Neuromed M. i M. Nastaj Sp.P
RECRUITING
Lublin
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
RECRUITING
Lublin
Warminsko Mazurskie Centrum Chorob Pluc w Olsztynie
RECRUITING
Olsztyn
Med-Polonia Sp. z o.o.
RECRUITING
Poznan
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o.
RECRUITING
Słupsk
Republic of Korea
Chungbuk National University Hospital
RECRUITING
Cheongju-si
Jeonbuk National University Hospital
RECRUITING
Jeonju
Kangbuk Samsung Hospital
RECRUITING
Seoul
Korea University Anam Hospital
RECRUITING
Seoul
Korea University Guro Hospital
RECRUITING
Seoul
Kyung Hee University Hospital
RECRUITING
Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital
RECRUITING
Seoul
Ajou University Hospital
RECRUITING
Suwon
The Catholic University Of Korea, St. Vincent's Hospital
RECRUITING
Suwon
Serbia
Clincial Centre of Serbia
RECRUITING
Belgrade
Institute for Pulmonary Diseases of Vojvodina
RECRUITING
Kamenitz
University Clinical Centre of Kragujevac
RECRUITING
Kragujevac
South Africa
Dr W M Szpak Inc - Rainbow Oncology
RECRUITING
Athlone Park
GVI Oncology, Langenhoven Drive Oncology Centre
RECRUITING
Port Elizabeth
Life Wilgers Hospital Wilgers Oncology Centre
RECRUITING
Pretoria
Abraham Oncology
RECRUITING
Richards Bay
Spain
Hospital General Universitario de Elche
RECRUITING
Alicante
Hospital Quironsalud Barcelona
RECRUITING
Barcelona
UOMI Cancer Center-Clinica Tres Torres
RECRUITING
Barcelona
Complejo Hospitalario de Jaen (University Hospital Ciudad De Jaen)
RECRUITING
Jaén
Hospital Clnico San Carlos (HCSC)
RECRUITING
Madrid
Hospital Universitario Fundacion Alcorcon
RECRUITING
Madrid
Hospital Universitario San Francisco de Asis
RECRUITING
Madrid
Hospital Quironsalud Malaga
RECRUITING
Málaga
Hospital De Mataro
RECRUITING
Mataró
Hospital Universitario Central de Asturias
RECRUITING
Oviedo
Hospital Universitario Nuestra Senora De Valme
RECRUITING
Seville
Hospital Universitario Virgen del Rocio
RECRUITING
Seville
Hospital Quironsalud Valencia
RECRUITING
Valencia
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulev
COMPLETED
Valencia
Taiwan
Dalin Tzu chi General Hospital - Buddhist Tzu chi Medical Foundation
RECRUITING
Chiayi City
National Taiwan University Hospital Yun-Lin Branch
RECRUITING
Douliu
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
RECRUITING
Kaohsiung County
Tri-Service General Hospital
RECRUITING
Neihu
Taipei Medical University (TMU) - Shuang Ho Hospital (SHH)
RECRUITING
New Taipei City
Chung Shan Medical University Hospital
RECRUITING
Taichung
Taichung Veterans General Hospital
RECRUITING
Taichung
National Cheng Kung University Hospital
RECRUITING
Tainan
National Taiwan University Hospital (NTUH)
RECRUITING
Taipei
Taipei Veterans General Hospital
COMPLETED
Taipei
Thailand
King Chulalongkorn Memorial Hospital, Chulalongkom University
RECRUITING
Bangkok
Vajira Hospital
RECRUITING
Bangkok
Mahidol University - Siriraj Hospital - Siriraj Clinical Research Center (SICRC)
RECRUITING
Bangkoknoi
Prince Of Songkla Hospital, Prince Of Songkhla University
RECRUITING
Hat Yai
Chiangrai Prachanukroh Hospital
RECRUITING
Muang
Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University
RECRUITING
Muang
Naresuan University Hospital
RECRUITING
Muang
Chulabhorn Hospital
RECRUITING
Talat Bang Khen
Turkey
Adana City Training and Research Hospital
RECRUITING
Adana
Medical Park Seyhan Hospital
RECRUITING
Adana
Ankara Bilkent City Hospital
RECRUITING
Ankara
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi
RECRUITING
Ankara
Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
RECRUITING
Ankara
Liv Hospital Ankara
RECRUITING
Ankara
Memorial Ankara Hospital
RECRUITING
Ankara
Ondokuz Mayis University Health Practice and Research Hospital
RECRUITING
Atakum
Uludag University Medical Faculty
RECRUITING
Bursa
Medical Point Gaziantep Hospital
RECRUITING
Gaziantep
Trakya University Faculty of Medicine
RECRUITING
İskender
Bezmialem Foundation University Medical Faculty
RECRUITING
Istanbul
Istanbul Medeniyet University Medical Faculty
RECRUITING
Istanbul
Yeditepe University Kosuyolu Hospital
RECRUITING
Istanbul
Gulhane Training and Research Hospital
RECRUITING
Keçiören
Kocaeli Universitesi Tip Fakultesi
RECRUITING
Kocaeli
Necmettin Erbakan University Meram Medical Faculty
RECRUITING
Konya
Sakarya Universitesi Tip Fakultesi
RECRUITING
Sakarya
Adana Ortadogu Hospital
RECRUITING
Seyhan
Namik Kemal Universitesi Hastanesi
RECRUITING
Tekirdağ
Gazi University Faculty of Medicine
RECRUITING
Yenimahalle
United Kingdom
Nottingham University Hospitals NHS Trust - Nottingham City Hospital
RECRUITING
Nottingham
Contact Information
Primary
Amgen Call Center
medinfo@amgen.com
866-572-6436
Time Frame
Start Date: 2024-09-09
Estimated Completion Date: 2028-05-29
Participants
Target number of participants: 927
Treatments
Experimental: ABP 234
Part 1: Participants will receive ABP 234 followed by pemetrexed administered with platinum-based chemotherapy (cisplatin or carboplatin). Part 2: Participants will receive ABP 234 followed by pemetrexed.
Experimental: Pembrolizumab (US)
Part 1: Participants will receive FDA-licensed pembrolizumab followed by pemetrexed administered with platinum-based chemotherapy (cisplatin or carboplatin). Part 2: Participants will receive FDA-licensed pembrolizumab followed by pemetrexed.
Experimental: Pembrolizumab (EU)
Part 1: Participants will receive EU-approved pembrolizumab followed by pemetrexed administered with platinum-based chemotherapy (cisplatin or carboplatin). Part 2: Participants will receive EU-approved pembrolizumab followed by pemetrexed.
Related Therapeutic Areas
Sponsors
Leads: Amgen