A Study to Compare ABP 234 and Keytruda® (Pembrolizumab) in Participants With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer
NCT ID: NCT06311721
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
927 participants
INTERVENTIONAL
2024-09-09
2028-05-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
ABP 234
Intravenous administration
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.
Pembrolizumab (US)
Intravenous administration
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.
Pembrolizumab (EU)
Intravenous administration
Interventions
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ABP 234
Intravenous administration
Pembrolizumab (US)
Intravenous administration
Pembrolizumab (EU)
Intravenous administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
99 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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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 Pregamino 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
Centro de Ensino e Pesquisa Reichow
Jardim Blumenau, 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
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
Oncocentro
Viña del Mar, Región de Valparaíso, Chile
Centro de Investigaciones Clinicas Vina del Mar Ltda.
Viña del Mar, Región de Valparaíso, Chile
Cdiem
Providencia, Santiago Metropolitan, Chile
Centro de Oncologa de Precisin
Region Metropolitana, Santiago Metropolitan, Chile
Clinica Santa Maria
Santiago, Santiago Metropolitan, 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 Ospedaliera Universitaria Di Ferrara
Cona, , 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
Napoli, , 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
Chugoku Central Hospital
Fukuyama, Hiroshima, Japan
Hiroshima Prefectural Hospital
Hiroshima, Hiroshima, Japan
Asahikawa Medical University Hospital
Asahikawa, Hokkaido, Japan, Japan
Hyogo Prefectural Amagasaki General Medical Center
Amagasaki, Hyōgo, Japan
Nippon Medical School Musashikosugi Hospital
Kawasaki-shi, Kanagawa, Japan
Yokohama City University Hospital
Yokohama, Kanagawa, Japan
Yokosuka Kyosai Hospital
Yokosuka, Kanagawa, Japan
Social Welfare Organization Imperial Gift Foundation, Inc. Saiseikai Kumamoto Hospital
Kumamoto, Kumamoto, Japan
Osaki Citizen Hospital
Ōsaki, Miyagi, Japan
Miyazaki Prefectural Miyazaki Hospital
Miyazaki, Miyazaki, Japan
Shinshu University Hospital
Matsumoto, Nagano, Japan
NHO Kinki Chuo Chest Medical Center
Sakai, Osaka Japan, Japan
Kawaguchi Municipal Medical Center
Kawaguchi-shi, Saitama, Japan
Seirei Hamamatsu General Hospital
Hamamatsu, Shizuoka, Japan
Hamamatsu Medical Center
Hamamatsu, Shizuoka, Japan, Japan
Ome Medical Center
Ome-shi, Tokyo, Japan
Hospital Sultanah Bahiyah
Alor Star, Kedah, Malaysia
Hospital Raja Perempuan Zainab II
Kota Bharu, Kelantan, Malaysia
Hospital Canselor Tuanku Muhriz UKM
Cheras, Kuala Lumpur, Malaysia
Sarawak General Hospital
Kuching, Sarawak, Malaysia
University of Malaya Medical Centre
Kuala Lumpur, , Malaysia
Hospital III Goyeneche
Cercado, Arequipa, Peru
Instituto Nacional De Enfermedades Neoplasicas
Surquillo, Lima, Peru, Peru
Hospital IV - Alberto Sabogal Sologuren Red Asistencial Sabogal
Bellavista, Provincia Constitucional del Callao, Peru
Centro Medico Monte Carmelo
Arequipa, , Peru
Hospital de Apoyo Maria Auxiliadora
Lima, , Peru
Clnica San Antonio
Trujillo, , Peru
Cebu Doctors University Hospital
Cebu City, Cebu, Philippines
Chong Hua Hospital
Cebu City, Cebu, Philippines
Perpetual Succour Hospital
Cebu City, Central Visayas, Philippines
Davao Doctors Hospital
Davao City, Davao Del Sur, Philippines
West Visayas State University Medical Center
Iloilo City, Iloilo, Philippines
Asian Hospital And Medical Center
Muntinlupa, National Capital Region, Philippines
Veterans Memorial Medical Center
Quezon City, National Capital Region, Philippines
Riverside Medical Center Inc
Bacolod City, Negros Occidental, Philippines
Philippine General Hospital
Manila, , Philippines
Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
Lublin, Lublin Voivodeship, Poland
Warminsko Mazurskie Centrum Chorob Pluc w Olsztynie
Olsztyn, Warmian-Masurian Voivodeship, Poland
Instytut MSF Sp. z o.o.
Lodz, , Poland
NZOZ Neuromed M. i M. Nastaj Sp.P
Lublin, , Poland
Med-Polonia Sp. z o.o.
Poznan, , Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o.
Słupsk, , Poland
Clincial Centre of Serbia
Belgrade, , Serbia
Institute for Pulmonary Diseases of Vojvodina
Kamenitz, , Serbia
University Clinical Centre of Kragujevac
Kragujevac, , Serbia
GVI Oncology, Langenhoven Drive Oncology Centre
Port Elizabeth, Eastern Cape, South Africa
Dr W M Szpak Inc - Rainbow Oncology
Athlone Park, KwaZulu-Natal, South Africa
Abraham Oncology
Richards Bay, KwaZulu-Natal, South Africa
The Catholic University Of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea
Jeonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, South Korea
Kyung Hee University Hospital
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Hospital General Universitario de Elche
Alicante, , Spain
UOMI Cancer Center-Clinica Tres Torres
Barcelona, , Spain
Hospital Quironsalud Barcelona
Barcelona, , Spain
Complejo Hospitalario de Jaen (University Hospital Ciudad De Jaen)
Jaén, , Spain
Hospital Universitario San Francisco de Asis
Madrid, , Spain
Hospital Clnico San Carlos (HCSC)
Madrid, , Spain
Hospital Universitario Fundacion Alcorcon
Madrid, , Spain
Hospital De Mataro
Mataró, , Spain
Hospital Quironsalud Malaga
Málaga, , Spain
Hospital Universitario Central de Asturias
Oviedo, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Universitario Nuestra Senora De Valme
Seville, , Spain
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulev
Valencia, , Spain
Hospital Quironsalud Valencia
Valencia, , Spain
Tri-Service General Hospital
Neihu, Taipei, Taiwan
National Taiwan University Hospital (NTUH)
Taipei, Zhongzheng Dist, Taiwan
Dalin Tzu chi General Hospital - Buddhist Tzu chi Medical Foundation
Chiayi City, , Taiwan
National Taiwan University Hospital Yun-Lin Branch
Douliu, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
Kaohsiung County, , Taiwan
Taipei Medical University (TMU) - Shuang Ho Hospital (SHH)
New Taipei City, , Taiwan
Chung Shan Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Mahidol University - Siriraj Hospital - Siriraj Clinical Research Center (SICRC)
Bangkoknoi, Bangkok, Thailand
Chiangrai Prachanukroh Hospital
Muang, Changwat Chiang Rai, Thailand
Naresuan University Hospital
Muang, Changwat Phitsanulok, Thailand
Prince Of Songkla Hospital, Prince Of Songkhla University
Hat Yai, Changwat Songkhla, Thailand
Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University
Muang, Chiang Mai, Thailand
Chulabhorn Hospital
Talat Bang Khen, Lak Si, Thailand
Vajira Hospital
Bangkok, , Thailand
King Chulalongkorn Memorial Hospital, Chulalongkom University
Bangkok, , Thailand
Adana Ortadogu Hospital
Seyhan, Adana, Turkey (Türkiye)
Gulhane Training and Research Hospital
Keçiören, Ankara, Turkey (Türkiye)
Gazi University Faculty of Medicine
Yenimahalle, Ankara, Turkey (Türkiye)
Trakya University Faculty of Medicine
İskender, Edirne, Turkey (Türkiye)
Ondokuz Mayis University Health Practice and Research Hospital
Atakum, Samsun, Turkey (Türkiye)
Medical Park Seyhan Hospital
Adana, , Turkey (Türkiye)
Adana City Training and Research Hospital
Adana, , Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi
Ankara, , Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Ankara, , Turkey (Türkiye)
Memorial Ankara Hospital
Ankara, , Turkey (Türkiye)
Liv Hospital Ankara
Ankara, , Turkey (Türkiye)
Ankara Bilkent City Hospital
Ankara, , Turkey (Türkiye)
Uludag University Medical Faculty
Bursa, , Turkey (Türkiye)
Medical Point Gaziantep Hospital
Gaziantep, , Turkey (Türkiye)
Bezmialem Foundation University Medical Faculty
Istanbul, , Turkey (Türkiye)
Yeditepe University Kosuyolu Hospital
Istanbul, , Turkey (Türkiye)
Istanbul Medeniyet University Medical Faculty
Istanbul, , Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi
Kocaeli, , Turkey (Türkiye)
Necmettin Erbakan University Meram Medical Faculty
Konya, , Turkey (Türkiye)
Sakarya Universitesi Tip Fakultesi
Sakarya, , Turkey (Türkiye)
Namik Kemal Universitesi Hastanesi
Tekirdağ, , Turkey (Türkiye)
Nottingham University Hospitals NHS Trust - Nottingham City Hospital
Nottingham, Nottinghamshire, United Kingdom
Countries
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Central Contacts
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2023-508336-57
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2024-514304-14-00
Identifier Type: OTHER
Identifier Source: secondary_id
20210033
Identifier Type: -
Identifier Source: org_study_id