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

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

The primary objective of this trial is to demonstrate pharmacokinetic (PK) similarity of ABP 234 compared with the pembrolizumab reference product (Keytruda®).

Study Overview

• Status: Active, not recruiting
• Conditions: Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: ABP 234; Drug: Pembrolizumab (US); Drug: Pembrolizumab (EU)

• Study Type: Interventional
• Enrollment (Actual): 315
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Córdoba, Argentina, 5001
    • IONC - Instituto Oncologico de Cordoba
  • Buenos Aires
    • Mar del Plata, Buenos Aires, Argentina, B7600
      • Instituto de Investigaciones Clinicas Mar del Plata
    • Pergamino, Buenos Aires, Argentina, B2700CPM
      • Centro de Investigacion Pergamino SA
  • Jujuy Province
    • San Salvador de Jujuy, Jujuy Province, Argentina, 4600
      • Fundación Ars Medica
  • Santa Fe Province
    • Rosario, Santa Fe Province, Argentina, S2000CVB
      • Sanatorio Británico de Rosario
    • Rosario, Santa Fe Province, Argentina, S2002KDT
      • Hospital Provincial del Centenario
• Austria
  • Klagenfurt, Austria, 9020
    • Klinikum Klagenfurt am Woerthersee
  • Linz, Austria, 4020
    • Ordensklinikum Linz GmbH Elisabethinen
• Brazil
  • Canoas, Brazil, 92030-000
    • Hospital Nossa Senhora Das Gracas
  • Curitiba, Brazil, 81480-580
    • CIONC - Centro Integrado de Oncologia de Curitiba
  • Porto Alegre, Brazil, 91350-200
    • Centro Integrado de Pesquisa em Oncologia - Hospital Nossa Senhora da Conceio
  • Rio de Janeiro, Brazil, 20231-050
    • Instituto Nacional de Cancer (INCA)
  • Rio de Janeiro, Brazil, 22775-001
    • Instituto Americas - Ensino, Pesquisa e Inovacao
  • Rio de Janeiro - RJ, Brazil, 22250-905
    • Oncoclinicas Rio de Janeiro S.A (Centro de Tratamento de Tumores Botafogo)
  • Salvador, Brazil, 41253- 190
    • Instituto D'or de Pesquisa e Ensino - Hospital São Rafael
  • São Paulo, Brazil, 01327-001
    • Hospital Alemao Oswaldo Cruz (HAOC)
  • São Paulo, Brazil, 04014-002
    • Instituto Brasileiro de Controle do Cancer - IBCC Oncologia
  • Ceará
    • Fortaleza, Ceará, Brazil, 60335-480
      • Crio - Centro Regional Integrado de Oncologia
  • Destrito Federal
    • Brasília, Destrito Federal, Brazil, 70390-150
      • OC Oncoclinicas Oncovida
  • Espírito Santo
    • Cachoeiro de Itapemirim, Espírito Santo, Brazil, 29308-014
      • Centro de Pesquisas Clinicas em Oncologia (CPCO)/HECI
    • Vitória, Espírito Santo, Brazil, 29043-260
      • Associacao Feminina de Educacao e Combate ao Cancer(AFECC) - Hospital Santa Rita
  • Estado de Bahia
    • Salvador, Estado de Bahia, Brazil, 40050-410
      • Hospital Santa Izabel, Santa Casa de Misericordia da Bahia
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30110-022
      • Cetus Oncologia S.A. Unidade Belo Horizonte
    • Belo Horizonte, Minas Gerais, Brazil, 30380-472
      • Nucleo de Ensino Pesquisa e Inovacao Mario Penna
    • Ipatinga, Minas Gerais, Brazil, 35162-189
      • Fundacao Sao Francisco Xavier - Hospital Marcio Cunha (HMC) - Unidade I
  • Paraná
    • Curitiba, Paraná, Brazil, 81520-060
      • Liga Paranaense de Combate ao Câncer - Hospital Erasto Gaertner
    • Londrina, Paraná, Brazil, 86015-520
      • Instituto de Cancer de Londrina - Hospital do Cancer de Londrina - HCL
  • Rio Grande do Norte
    • Natal, Rio Grande do Norte, Brazil, 59062-000
      • Liga Contra o Cancer
  • Rio Grande do Sul
    • Bento Gonçalves, Rio Grande do Sul, Brazil, 95700-000
      • Hospital Tacchini
    • Ijuí, Rio Grande do Sul, Brazil, 98700-000
      • ONCOSITE Centro de Pesquisa Clínica Em Oncologia
    • Lajeado, Rio Grande do Sul, Brazil, 95900-000
      • Hospital Bruno Born
    • Passo Fundo, Rio Grande do Sul, Brazil, 99010-260
      • Hospital da Cidade de Passo Fundo - HCPF
    • Pelotas, Rio Grande do Sul, Brazil, 96020-080
      • Unidade de Pesquisa Clinica em Oncologia Ltda (UPCO) (Clinica Lacks)
    • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
      • Centro de Pesquisa em Oncologia - Hospital Sao Lucas da PUC Rio Grande do Sul
    • Porto Alegre Rio Grande Do Sul, Rio Grande do Sul, Brazil, 90160-093
      • Associacao dos Functionarios Publicos do Estado do Rio Grande do Sul - Hospital Ernesto Dornelles (H
  • Santa Catarina
    • Chapecó, Santa Catarina, Brazil, 89801-355
      • Centro de Oncologia de Santa Catarina Ltda / Supera Oncologia
    • Florianópolis, Santa Catarina, Brazil, 88020-210
      • CEPEN Centro de Pesquisa e Ensino em Saude de Santa Catarina
    • Joinville, Santa Catarina, Brazil, 89201-260
      • Instituto Joinvillense de Hematologia e Oncologia SS Ltda - Clinica de Hematologia e Oncologia
  • São Paulo
    • Barretos, São Paulo, Brazil, 14784-400
      • Fundação Pio XII - Hospital de Câncer de Barretos
    • Campinas, São Paulo, Brazil, 13060-904
      • Centro de Pesquisa São Lucas
    • Mogi das Cruzes, São Paulo, Brazil, 08730-500
      • Centro Oncologico Mogi das Cruzes
    • Ribeirão Preto, São Paulo, Brazil, 14015-130
      • Instituto Ribeiraopretano de Combate ao Cancer (IRPCc) - IRPCC
    • Santo André, São Paulo, Brazil, 09060-0650
      • Faculdade de Medicina do ABC - Centro de Estudos e Pesqulsas de Hematologia e Oncologia
    • São José do Rio Preto, São Paulo, Brazil, 15090-000
      • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base de Sao Jose do R
• Bulgaria
  • Dobrich, Bulgaria, 5500
    • MHAT Dobrich AD
  • Sofia, Bulgaria, 1797
    • University Multiprofile Hospital for Active Treatment Sofiamed
  • Sofia-Grad
    • Sofia, Sofia-Grad, Bulgaria, 1431
      • University Multi-Profile Hospital for Active Treatment (UMHAT) St. Ivan Rilski
• Chile
  • Santiago, Chile, 2209
    • K2 Oncology
  • Santiago, Chile, 8240000
    • Icegclinic Research and Care
  • Santiago Metropolitan
    • Providencia, Santiago Metropolitan, Chile, 7500859
      • CDIEM - Centro de Investigacion y Especialidades Medicas
    • Region Metropolitana, Santiago Metropolitan, Chile, 7560908
      • Centro de Oncologa de Precisin
    • Santiago, Santiago Metropolitan, Chile, 7520349
      • Clinica Santa Maria
  • Valparaiso
    • Viña del Mar, Valparaiso, Chile, 2520598
      • Oncocentro Apys
    • Viña del Mar, Valparaiso, Chile, 2540364
      • Centro de Investigaciones Clinicas Vina del Mar Ltda.
• France
  • Bordeaux, France, 33075
    • Centre Hospitalier Universitaire de Bordeaux - Hopital Saint - Andre
  • Limoges, France, 87000
    • Centre Hospitalier Universitaire (CHU) De Limoges Hopital Dupuytren
  • Marseille, France, 13003
    • Hôpital Européen Marseille
  • Montpellier, France, 34070
    • Clinique Clementville-Gcs Centre De Cancerologie Du Grand Montpellier
  • Nîmes, France, 30029
    • Centre Hospitalier Universitaire de Nimes (CHU) - Hopital Universitaire Caremeau
  • Toulon, France, 83000
    • Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (C.H.I.T.S) - Hospital Font-Pre
  • Valenciennes, France, 59300
    • Clinique Teissier
  • Vantoux, France, 57070
    • Hopital Robert Schuman
• Georgia
  • Batumi, Georgia, 6000
    • High Technology Hospital MedCenter Ltd
  • Tbilisi, Georgia, 0112
    • Llc Todua Clinic
  • Tbilisi, Georgia, 0112
    • Israel-Georgian Medical Research Clinic Healthycore
  • Tbilisi, Georgia, 0162
    • New Hospitals
  • Tbilisi, Georgia, 0160
    • TIM -Tbilisi Institute of Medicine
  • Tbilisi, Georgia, 0168
    • Medulla - Clinics And Medical Centers
• Germany
  • Essen, Germany, 45136
    • Evang. Kliniken Essen Mitte GmbH
  • Hösbach, Germany, 63768
    • Studienzentrum Aschaffenburg
  • Landshut, Germany, 84036
    • Haematologie, Onkologie und Palliativmedizin, Tagesklinik Landshut
  • Neumünster, Germany, 24534
    • FEK - Friedrich-Ebert-Krankenhaus Neumuenster GmbH
• Italy
  • Cona, Italy, 44124
    • Azienda Ospedaliero - Universitaria di Ferrara
  • Cremona, Italy, 26100
    • Azienda Socio Sanitaria Territoriale di Cremona
  • Milan, Italy, 20122
    • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
  • Naples, Italy, 80131
    • UOC Oncoematologia AOU Luigi Vanvitelli
  • Naples, Italy, 80147
    • ASL Napoli 1 Centro-Ospedale del Mare
  • Ravenna, Italy, 48121
    • AUSL Della Romagna - Ospedale S.Maria delle Croci
  • Sondrio, Italy, 23100
    • S.C. Oncologia Medica-Presidio Ospedaliero Sondrio
  • Terni, Italy, 05100
    • Azienda Ospedaliera Santa Maria Terni
• Japan
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 457-8510
      • Japan Community Healthcare Organization Chukyo Hospital
  • Chiba
    • Funabashi-shi, Chiba, Japan, 273-8588
      • Funabashi Municipal Medical Center
  • Fukuoka
    • Fukuoka, Fukuoka, Japan, 812-8582
      • Kyushu University Hospital
    • Iizuka-shi, Fukuoka, Japan, 820-8505
      • Aso Iizuka Hospital
  • Gunma
    • Maebashi, Gunma, Japan, 371-0811
      • Japanese Red Cross Maebashi Hospital
  • Hiroshima
    • Fukuyama, Hiroshima, Japan, 720-0001
      • Chugoku Central Hospital
    • Hiroshima, Hiroshima, Japan, 734-8530
      • Hiroshima Prefectural Hospital
  • Hokkaido, Japan
    • Asahikawa, Hokkaido, Japan, Japan, 078-8510
      • Asahikawa Medical University Hospital
  • Hyōgo
    • Amagasaki, Hyōgo, Japan, 660-8550
      • Hyogo Prefectural Amagasaki General Medical Center
  • Kanagawa
    • Kawasaki-shi, Kanagawa, Japan, 211-8533
      • Nippon Medical School Musashikosugi Hospital
    • Yokohama, Kanagawa, Japan, 236-0004
      • Yokohama City University Hospital
    • Yokosuka, Kanagawa, Japan, 238-8558
      • Yokosuka Kyosai Hospital
  • Kumamoto
    • Kumamoto, Kumamoto, Japan, 861-4193
      • Social Welfare Organization Imperial Gift Foundation, Inc. Saiseikai Kumamoto Hospital
  • Miyagi
    • Ōsaki, Miyagi, Japan, 989-6183
      • Osaki Citizen Hospital
  • Miyazaki
    • Miyazaki, Miyazaki, Japan, 880-8510
      • Miyazaki Prefectural Miyazaki Hospital
  • Nagano
    • Matsumoto, Nagano, Japan, 390-8621
      • Shinshu University Hospital
  • Osaka Japan
    • Sakai, Osaka Japan, Japan, 591-8555
      • NHO Kinki Chuo Chest Medical Center
  • Saitama
    • Kawaguchi-shi, Saitama, Japan, 333-0833
      • Kawaguchi Municipal Medical Center
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan, 430-8558
      • Seirei Hamamatsu General Hospital
  • Shizuoka, Japan
    • Hamamatsu, Shizuoka, Japan, Japan, 432-8580
      • Hamamatsu Medical Center
  • Tokyo
    • Ome-shi, Tokyo, Japan, 198-0042
      • Ome Medical Center
• Malaysia
  • Kuala Lumpur, Malaysia, 59100
    • University of Malaya Medical Centre
  • Kedah
    • Alor Star, Kedah, Malaysia, 05460
      • Hospital Sultanah Bahiyah
  • Kelantan
    • Kota Bharu, Kelantan, Malaysia, 15586
      • Raja Perempuan Zainab II Hospital
  • Kuala Lumpur
    • Cheras, Kuala Lumpur, Malaysia, 56000
      • Hospital Canselor Tuanku Muhriz UKM
  • Sarawak
    • Kuching, Sarawak, Malaysia, 93586
      • Sarawak General Hospital
• Peru
  • Arequipa, Peru, 04001
    • Centro Medico Monte Carmelo
  • Arequipa, Peru, 04001
    • Clinic Vallesur Arequipa
  • Lima, Peru, 15801
    • Hospital de Apoyo Maria Auxiliadora
  • Trujillo, Peru, 13008
    • Clnica San Antonio
  • Arequipa
    • Cercado, Arequipa, Peru, 04001
      • Hospital III Goyeneche
  • Lima, Peru
    • Surquillo, Lima, Peru, Peru, 15038
      • Instituto Nacional de Enfermedades Neoplasicas
  • Provincia Constitucional del Callao
    • Bellavista, Provincia Constitucional del Callao, Peru, 07001
      • Hospital IV - Alberto Sabogal Sologuren Red Asistencial Sabogal
• Philippines
  • Manila, Philippines, 1000
    • Philippine General Hospital
  • Cebu
    • Cebu City, Cebu, Philippines, 6000
      • Chong Hua Hospital
    • Cebu City, Cebu, Philippines, 6000
      • Cebu Doctors University Hospital
  • Central Visayas
    • Cebu City, Central Visayas, Philippines, 6000
      • Perpetual Succour Hospital
  • Davao Del Sur
    • Davao City, Davao Del Sur, Philippines, 8000
      • Davao Doctors Hospital
  • Iloilo
    • Iloilo City, Iloilo, Philippines, 5000
      • West Visayas State University Medical Center
  • NCR
    • Quezon City, NCR, Philippines, 1102
      • St. Lukes Medical Center
  • National Capital Region
    • Muntinlupa, National Capital Region, Philippines, 1780
      • Asian Hospital and Medical Center
    • Quezon City, National Capital Region, Philippines, 1110
      • Veterans Memorial Medical Center
  • Negros Occidental
    • Bacolod City, Negros Occidental, Philippines, 6100
      • Riverside Medical Center Inc
  • Western Visayas
    • Iloilo City, Western Visayas, Philippines, 5000
      • St. Paul's Hospital of Iloilo, Inc.
• Poland
  • Lodz, Poland, 90-302
    • Instytut MSF Sp. z o.o.
  • Lublin, Poland, 20-064
    • NZOZ Neuromed M. i M. Nastaj Sp.P
  • Poznan, Poland, 60-693
    • Med-Polonia Sp. z o.o.
  • Słupsk, Poland, 76-200
    • Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o.
  • Kuyavian-Pomeranian Voivodeship
    • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-796
      • Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy
  • Lublin Voivodeship
    • Lublin, Lublin Voivodeship, Poland, 20-954
      • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
  • Warmian-Masurian Voivodeship
    • Olsztyn, Warmian-Masurian Voivodeship, Poland, 10-357
      • Warminsko Mazurskie Centrum Chorob Pluc w Olsztynie
• Serbia
  • Belgrade, Serbia, 11000
    • Clincial Centre of Serbia
  • Kamenitz, Serbia, 21204
    • Institute for Pulmonary Diseases of Vojvodina
  • Kragujevac, Serbia, 34000
    • University Clinical Centre of Kragujevac
• South Africa
  • Eastern Cape
    • Port Elizabeth, Eastern Cape, South Africa, 6045
      • GVI Oncology, Langenhoven Drive Oncology Centre
  • Gauteng
    • Pretoria, Gauteng, South Africa, 0002
      • University of Pretoria and Steve Biko Academic Hospital Complex
    • Pretoria, Gauteng, South Africa, 0040
      • Life Wilgers Hospital Wilgers Oncology Centre
  • KwaZulu-Natal
    • Athlone Park, KwaZulu-Natal, South Africa, 4126
      • Dr W M Szpak Inc - Rainbow Oncology
    • Richards Bay, KwaZulu-Natal, South Africa, 3900
      • Abraham Oncology
• South Korea
  • Seoul, South Korea, 03181
    • Kangbuk Samsung Hospital
  • Seoul, South Korea, 06591
    • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Seoul, South Korea, 02841
    • Korea University Anam Hospital
  • Seoul, South Korea, 02447
    • Kyung Hee University Hospital
  • Seoul, South Korea, 08308
    • Korea University Guro Hospital
  • Gyeonggi-do
    • Suwon, Gyeonggi-do, South Korea, 16499
      • Ajou University Hospital
    • Suwon, Gyeonggi-do, South Korea, 16247
      • The Catholic university of Korea, St. Vincent's Hospital
  • Jeollabuk-do
    • Jeonju, Jeollabuk-do, South Korea, 54907
      • Jeonbuk National University Hospital
  • North Chungcheong
    • Cheongju-si, North Chungcheong, South Korea, 28644
      • Chungbuk National University Hospital
• Spain
  • Alicante, Spain, 03203
    • Hospital General Universitario de Elche
  • Barcelona, Spain, 08023
    • Hospital Quironsalud Barcelona
  • Barcelona, Spain, 08017
    • Uomi Cancer Center-Clinica Tres Torres
  • Jaén, Spain, 23007
    • Complejo Hospitalario de Jaen (University Hospital Ciudad De Jaen)
  • Madrid, Spain, 28922
    • Hospital Universitario Fundacion Alcorcon
  • Madrid, Spain, 28002
    • Hospital Universitario San Francisco de Asis
  • Madrid, Spain, 28040
    • Hospital Unifersitario Fundacion Jimenez Diaz
  • Mataró, Spain, 08304
    • Hospital de Mataró
  • Málaga, Spain, 29004
    • Hospital Quironsalud Malaga
  • Oviedo, Spain, 33011
    • Hospital Universitario Central de Asturias
  • Seville, Spain, 41013
    • Hospital Universitario Virgen del Rocio
  • Seville, Spain, 41014
    • Hospital Universitario Nuestra Señora de Valme
  • Valencia, Spain, 46026
    • Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulev
  • Valencia, Spain, Â 46010
    • Hospital Quirónsalud Valencia
• Taiwan
  • Chiayi City, Taiwan, 62247
    • Dalin Tzu chi General Hospital - Buddhist Tzu chi Medical Foundation
  • Douliu, Taiwan, 640
    • National Taiwan University Hospital Yun-Lin Branch
  • Kaohsiung City, Taiwan, 80756
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Kaohsiung County, Taiwan, 83301
    • Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
  • New Taipei City, Taiwan, 235
    • Taipei Medical University (TMU) - Shuang Ho Hospital (SHH)
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Taichung, Taiwan, 402
    • Chung Shan Medical University Hospital
  • Tainan, Taiwan, 70403
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taipei
    • Neihu, Taipei, Taiwan, 114202
      • Tri-Service General Hospital
  • Zhongzheng Dist
    • Taipei, Zhongzheng Dist, Taiwan, 10050
      • National Taiwan University Hospital (NTUH)
• Thailand
  • Bangkok, Thailand, 10300
    • Faculty of Medicine Vajira Hospital, Navamindradhiraj University
  • Bangkok, Thailand, 10330
    • King Chulalongkorn Memorial Hospital, Chulalongkom University
  • Bangkok
    • Bangkoknoi, Bangkok, Thailand, 10700
      • Mahidol University - Siriraj Hospital - Siriraj Clinical Research Center (SICRC)
  • Changwat Chiang Rai
    • Muang, Changwat Chiang Rai, Thailand, 57000
      • Chiangrai Prachanukroh Hospital
  • Changwat Phitsanulok
    • Muang, Changwat Phitsanulok, Thailand, 65000
      • Naresuan University Hospital
  • Changwat Songkhla
    • Hat Yai, Changwat Songkhla, Thailand, 90110
      • Prince Of Songkla Hospital, Prince Of Songkhla University
  • Chiang Mai
    • Muang, Chiang Mai, Thailand, 52000
      • Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University
  • Lak Si
    • Talat Bang Khen, Lak Si, Thailand, 10210
      • Chulabhorn Hospital
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01230
    • Medical Park Seyhan Hospital
  • Adana, Turkey (Türkiye), 4522
    • Adana City Training and Research Hospital
  • Ankara, Turkey (Türkiye), 06800
    • Ankara Bilkent City Hospital
  • Ankara, Turkey (Türkiye), 06680
    • Liv Hospital Ankara
  • Ankara, Turkey (Türkiye), 06100
    • Ankara Universitesi Tip Fakultesi Cebeci Hastanesi
  • Ankara, Turkey (Türkiye), 06520
    • Memorial Ankara Hospital
  • Ankara, Turkey (Türkiye), 06200
    • Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
  • Bursa, Turkey (Türkiye), 16059
    • Uludag University Medical Faculty
  • Gaziantep, Turkey (Türkiye), 27584
    • Medical Point Gaziantep Hospital
  • Istanbul, Turkey (Türkiye), 34718
    • Yeditepe University Kosuyolu Hospital
  • Istanbul, Turkey (Türkiye), 34093
    • Bezmialem Foundation University Medical Faculty
  • Istanbul, Turkey (Türkiye), 34720
    • Istanbul Medeniyet University Medical Faculty
  • Kocaeli, Turkey (Türkiye), 41380
    • Kocaeli Universitesi Tip Fakultesi
  • Konya, Turkey (Türkiye), 42080
    • Necmettin Erbakan University Meram Medical Faculty
  • Sakarya, Turkey (Türkiye), 54290
    • Sakarya Universitesi Tip Fakultesi
  • Tekirdağ, Turkey (Türkiye), 59100
    • Namik Kemal Universitesi Hastanesi
  • Adana
    • Seyhan, Adana, Turkey (Türkiye), 67055
      • Adana Ortadogu Hospital
  • Ankara
    • Keçiören, Ankara, Turkey (Türkiye), 06010
      • Gulhane Training and Research Hospital
    • Yenimahalle, Ankara, Turkey (Türkiye), 06560
      • Gazi university faculty of medicine
  • Edirne
    • İskender, Edirne, Turkey (Türkiye), 22130
      • Trakya University Faculty of Medicine
  • Samsun
    • Atakum, Samsun, Turkey (Türkiye), 55280
      • Ondokuz Mayis University Health Practice and Research Hospital
• United Kingdom
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
      • Nottingham University Hospitals NHS Trust - Nottingham City Hospital
• United States
  • California
    • Beverly Hills, California, United States, 90212
      • Precision NextGen Oncology and Research Center
    • Cerritos, California, United States, 90703
      • TOI Clinical Research
    • Los Alamitos, California, United States, 90720-3309
      • Cancer and Blood Specialty Clinic (CBSC)
    • Los Angeles, California, United States, 90067
      • Valkyrie Clinical Trials
    • Whittier, California, United States, 90602
      • PIH Health Hospital
  • Florida
    • Hollywood, Florida, United States, 33024
      • Millennium Oncology - Hollywood
    • Tamarac, Florida, United States, 33321
      • BRCR Medical Center Inc.
  • Illinois
    • Plainfield, Illinois, United States, 60585
      • Accellacare Duly
  • Iowa
    • Ames, Iowa, United States, 50010
      • Accellacare of McFarland
  • Michigan
    • Farmington Hills, Michigan, United States, 48334
      • Detroit Clinical Research Center, PC
  • New York
    • Shirley, New York, United States, 11967
      • North Shore Hematology-Oncology Associates P.C. d/b/a New York Cancer & Blood Specialists
  • Ohio
    • Canton, Ohio, United States, 44718
      • Gabrail Cancer Center Research
  • Texas
    • Houston, Texas, United States, 77090
      • Millennium Research and Clinical Development, LLC
    • San Antonio, Texas, United States, 78217
      • Texas Oncology, P.A
  • Virginia
    • Wytheville, Virginia, United States, 24382
      • Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: ABP 234; Intravenous administration
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.	Drug: Pembrolizumab (US); Intravenous administration; Other Names: Keytruda®
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.	Drug: Pembrolizumab (EU); Intravenous administration; Other Names: Keytruda®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the serum concentration-time curve (AUC) from time 0 to 21 days (AUC21d) of ABP 234	21 days
AUC at steady state between Week 16 and Week 19 (AUCtau_ss) of ABP 234	Week 16 through Week 19
AUC21d of pembrolizumab (US)	21 days
AUC21d of pembrolizumab (EU)	21 days
AUCtau_ss of pembrolizumab (US)	Week 16 through Week 19
AUCtau_ss of pembrolizumab (EU)	Week 16 through Week 19

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response (OR)	OR defined as an overall response of confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.	Week 49
OR		Week 13
OR		Week 31
Duration of response (DOR)		Up to 2.5 years
Progression-free survival (PFS)		Up to 2.5 years
Overall survival (OS)		Up to 2.5 years
Maximum observed serum concentration following the first dose (Cmax_dose1) of ABP 234		Day 1 up to Week 107
Cmax_dose1 of pembrolizumab (US)		Day 1 up to Week 107
Cmax_dose1 of pembrolizumab (EU)		Day 1 up to Week 107
Time to maximum concentration following the first dose (tmax_dose1) of ABP 234		Day 1 up to Week 107
Tmax_dose1 of pembrolizumab (US)		Day 1 up to Week 107
Tmax_dose1 of pembrolizumab (EU)		Day 1 up to Week 107
Maximum observed serum concentration (Cmax) at steady state (Cmax_ss) of ABP 234		Week 16 through Week 19
Cmax_ss of pembrolizumab (US)		Week 16 through Week 19
Cmax_ss of of pembrolizumab (EU)		Week 16 through Week 19
Time to maximum concentration at steady state (tmax_ss) of ABP 234		Week 16 through Week 19
Tmax_ss of pembrolizumab (US)		Week 16 through Week 19
Tmax_ss of pembrolizumab (EU)		Week 16 through Week 19
Trough serum concentrations at pre-dose of week 4 (Ctrough_w4) of ABP 234		Week 4
Ctrough_w4 of pembrolizumab (US)		Week 4
Ctrough_w4 of pembrolizumab (EU)		Week 4
Trough serum concentrations at steady state (Ctrough_ss) at pre-dose of ABP 234		Week 16 through Week 19
Ctrough_ss at pre-dose of pembrolizumab (US)		Week 16 through Week 19
Ctrough_ss at pre-dose of pembrolizumab (EU)		Week 16 through Week 19
Number of participants who experience a Treatment-emergent adverse event		Up to 2.5 years
Number of participants who experience a Treatment-emergent serious adverse event		Up to 2.5 years
Number of participants who experience a Treatment-emergent adverse event of interest		Up to 2.5 years
Number of participants who experience anti-drug antibodies (ADA)		Up to 2.5 years

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2024
• Primary Completion (Estimated): January 10, 2028
• Study Completion (Estimated): April 24, 2028

Study Registration Dates

• First Submitted: March 8, 2024
• First Submitted That Met QC Criteria: March 8, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; pembrolizumab
• Other Study ID Numbers: 20210033; 2023-508336-57 (EudraCT Number); 2024-514304-14-00 (Other Identifier: EUCTR)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
• IPD Sharing Time Frame: Data sharing requests relating to this trial will be considered beginning 18 months after the trial has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this trial.
• IPD Sharing Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen trial/trials in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No