Pharmacokinetic Similarity Between ABP 234 and Keytruda® (Pembrolizumab)
NCT ID: NCT06430866
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
154 participants
INTERVENTIONAL
2024-09-12
2026-12-14
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ABP 234
Participants will receive ABP 234 every 3 weeks (Q3W) for up to 12 months.
ABP 234
Administered by intravenous (IV) injection.
Pembrolizumab
Participants will receive pembrolizumab Q3W for up to 12 months.
Pembrolizumab
Administered by IV injection.
Interventions
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ABP 234
Administered by intravenous (IV) injection.
Pembrolizumab
Administered by IV injection.
Eligibility Criteria
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Inclusion Criteria
* Pathological diagnosis of non-squamous NSCLC.
* Stage IB (T2 ≥ 4 cm), II, or IIIA NSCLC after complete surgical resection and received platinum-based chemotherapy.
* For programmed death-ligand 1 (PD-L1) testing, tumor tissue from the resected site of disease must be sent, received, and analyzed for biomarkers.
* Treated with platinum-based chemotherapy:
1. Chemotherapy must have begun within 12 weeks after the resection surgery.
2. The last chemotherapy dose must have been completed at least 3 weeks and no more than 12 weeks before the participant is randomized.
* Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1.
* Epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), and ROS-1 negative.
* Have adequate organ function as indicated by laboratory values.
* Absence of severe comorbidities that in the opinion of the investigator might hamper participation in the study and/or treatment administration.
* Participants must sign approved informed consent form (ICF).
Exclusion Criteria
* Prior treatment with anti-programmed cell death protein 1 and anti-PD-L1/2 modulating agents in adjuvant setting.
* History or presence of immune-mediated disorders.
* Participants with type 1 diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or skin disorders not requiring systemic treatment are permitted to enroll.
* Participant has positive screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C (HCV).
* History of congenital immunodeficiency diseases, prior allogeneic stem cell transplantation, or organ transplantation.
* History of any other malignancy other than NSCLC within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, papillary thyroid cancer treated with surgery, etc.
* Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including active viral or other hepatitis virus, current alcohol abuse or cirrhosis.
* Surgery or chemotherapy-related toxicity not resolved to grade 1 with the exception of grade ≤ 2 alopecia, fatigue, neuropathy, and lack of appetite/nausea.
* Woman of childbearing potential who is pregnant or is breast feeding.
* Woman of childbearing potential who is not consenting to use highly effective methods of birth control.
* Man with a partner of childbearing potential who does not consent to use highly effective methods of birth control.
* Participant has known hypersensitivity to monoclonal antibodies or to any of the excipients of the investigational product (IP).
* Active cardiac disease or history of cardiac dysfunction, that in the judgment of the investigator would place the participant at additional risk when participating in the study.
* Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current neumonitis/interstitial lung disease.
* Live vaccine therapy within 4 weeks prior to IP administration.
* Participation in another investigational drug study within 30 days prior to IP administration.
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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Fundacion ARS Medica
San Salvador de Jujuy, Jujuy Province, Argentina
Ionc Instituto Oncologico De Cordoba
Córdoba, , Argentina
University Multiprofile Hospital for Active Treatment Sofiamed
Sofia, , Bulgaria
Cdiem
Providencia, Region Metropolotana, Chile
Centro de Investigaciones Clinicas Vina del Mar Ltda.
Viña Del Mar, Región de Valparaíso, Chile
Centro de Investigacin de Enfermedades Respiratorias e Inmunologicas Limitada CIERI
Viña del Mar, Región de Valparaíso, Chile
Instituto Oncologico Fundacion Arturo Lopez Perez (FALP)
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
Clinique Belharra Ramsay Sante
Bayonne, , France
Centre Hospitalier Universitaire de Bordeaux - Hopital Saint - Andre
Bordeaux, , France
Centre Francois Baclesse
Caen, , France
Hopital Europeen Marseille
Marseille, , France
Hopital Bichat, APHP
Paris, , France
Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (C.H.I.T.S) - Hopital Sainte Musse
Toulon, , France
Hopital Robert Schuman
Vantoux, , France
LLC Todua Clinic
Tbilisi, , Georgia
New Hospitals
Tbilisi, , Georgia
Studienzentrum Aschaffenburg
Aschaffenburg, , Germany
Kliniken Essen Mitte, Evang. Huyssens-Stiftung, Internistische Onkologie und Hmatologie mit integire
Essen, , Germany
Azienda Ospedaliera Universitaria Di Ferrara
Cona, , Italy
Azienda Ospedaliera S. Croce e Carle
Cuneo, , Italy
Azienda Ospedaliero-Universitaria Careggi
Florence, , Italy
Ospedale Versilia
Lucca, , Italy
Azienda USL 2 Lucca
Lucca, , Italy
AOU Cagliari-Policlinico Universitario Duilio Casula di Monserrato-UOC Oncologia Medica
Monserrato, , Italy
ASL Napoli 1 Centro-Ospedale del Mare
Napoli, , Italy
Casa Di Cura Polispecialistica Dott Pederzoli
Peschiera del Garda, , Italy
AUSL Della Romagna - Ospedale S.Maria delle Croci
Ravenna, , Italy
IRCCS Istituto clinico humanitas - Humanitas Mirasole spa
Rozzano, , Italy
Azienda Ospedaliera Santa Maria Terni
Terni, , Italy
ASST Sette Laghi
Varese, , Italy
Hospital Raja Perempuan Zainab II
Kota Bharu, Kelantan, Malaysia
Hospital Canselor Tuanku Muhriz UKM
Cheras, Kuala Lumpur, Malaysia
Hospital Umum Sarawak
Kuching, Sarawak, Malaysia
Preparaciones Oncolgicas S.C.
León, Guanajuato, Mexico
Investigacion Biomedica para el Desarrollo de Nuevos Farmacos SA de CV
Zapopan, Jalisco, Mexico
Centro Medico Dalinde
Cuauhtémoc, Mexico City, Mexico
Accelerium Clinical Research
Monterrey, Nuevo León, Mexico
Consultorio del Dr. Joaquin Gabriel Reinoso Toledo
Monterrey, Nuevo León, Mexico
iCan Oncology Center S.A. de C.V.
Monterrey, Nuevo León, Mexico
Clinica Integral Internacional de Oncolgia S de RL de CV
Puebla City, , Mexico
Cebu Doctors University Hospital
Cebu City, Cebu, Philippines
Davao Doctors Hospital
Davao City, Davao Del Sur, Philippines
Makati Medical Center
Makati City, 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
Specjalistyczne Gabinety Sp. z o.o
Krakow, , Poland
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu
Przemyśl, , Poland
Gyncentrum Szpital
Sosnowiec, , Poland
Institutul Oncologic Prof. Dr. Ion Chiricuta
Cluj-Napoca, Cluj, Romania
Oncocenter Oncologie Clinica S.R.L
Timișoara, Timiș County, Romania
Oncomed
Timișoara, Timiș County, Romania
S.C. Medisprof S.R.L
Cluj-Napoca, , Romania
Centrul de Oncologie Euroclinic srl
Jud. Iasi, , Romania
Clincial Centre of Serbia
Belgrade, , Serbia
Institute for Pulmonary Diseases of Vojvodina
Kamenitz, , Serbia
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
Pusan National University Hospital (PNUH)
Busan, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Kyung Hee University Hospital
Seoul, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Asan Medical Center (AMC)
Seoul, , South Korea
Seoul Metropolitan Government - Seoul National University Boramae Medical Center
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Centro Oncologico de Galicia
A Coruna Galicia, , Spain
Complejo Hospitalario Universitario A Coruna
A Coruña, , Spain
Hospital General Universitario de Elche
Alicante, , Spain
Institut Catala d'Oncologia Badalona, Hospital Germans Trias I Pujol
Badalona, , Spain
UOMI Cancer Center-Clinica Tres Torres
Barcelona, , Spain
Hospital Quironsalud Barcelona
Barcelona, , Spain
Hospital Universitari Quiron Dexeus Barcelona
Barcelona, , Spain
Hospital Clinic de Barcelona (Hospital Clinic i Provincial)
Barcelona, , Spain
Hospital Universitario de Jerez
Jerez de la Frontera, , Spain
Hospital Universitario San Francisco de Asis
Madrid, , Spain
Clinica MD Anderson International
Madrid, , Spain
Hospital Clnico San Carlos (HCSC)
Madrid, , Spain
Hospital Universitario Madrid Sanchinarro - Centro Integral Oncologico Clara Campal (CIOCC)
Madrid, , Spain
Hospital Universitario Fundacion Alcorcon
Madrid, , Spain
Hospital De Mataro
Mataró, , Spain
Hospital Quironsalud Malaga
Málaga, , Spain
Complejo Hospitalario Universitario de Ourense
Ourense, , Spain
Complejo Hospitalario Universitario De Santiago De Compostela
Santiago de Compostela, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Universitario De Valme
Seville, , Spain
Fundacion Instituto Valenciano de Oncologia
Valencia, , Spain
Hospital Universitario Dr. Peset
Valencia, , Spain
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulev
Valencia, , Spain
Hospital Clinico Univ Valladolid
Valladolid, , Spain
National Taiwan University Hospital (NTUH)
Taipei, Zhongzheng Dist, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
Kaohsiung County, , Taiwan
Chung Shan Medical University Hospital
Taichung, , Taiwan
National Cheng Kung University
Tainan, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Mahidol University - Siriraj Hospital - Siriraj Clinical Research Center (SICRC)
Bangkoknoi, Bangkok, Thailand
King Chulalongkorn Memorial Hospital, Chulalongkom University
Pathumwan, Bangkok, Thailand
Lampang Cancer Hospital
Muang, Changwat Lampang, 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
Vajira Hospital
Bangkok, , Thailand
Gazi University Faculty of Medicine
Yenimahalle, Ankara, Turkey (Türkiye)
Trakya University Faculty of Medicine
İskender, Edirne, Turkey (Türkiye)
Medical Park Seyhan Hospital
Adana, , Turkey (Türkiye)
Adana City Training and Research Hospital
Adana, , Turkey (Türkiye)
Gulhane Training and Research Hospital
Ankara, , 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)
Baskent University Ankara Hospital
Ankara, , Turkey (Türkiye)
Uludag University Faculty of Medicine
Bursa, , Turkey (Türkiye)
Medical Point Gaziantep Hospital
Gaziantep, , Turkey (Türkiye)
Bezmialem Foundation University Medical Faculty
Istanbul, , Turkey (Türkiye)
Sakarya University - Faculty of Medicine
Sakarya, , Turkey (Türkiye)
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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20230127
Identifier Type: -
Identifier Source: org_study_id