Pharmacokinetic Similarity Between ABP 234 and Keytruda® (Pembrolizumab) (Eucalyptus)

A Randomized, Double-blind Study to Compare the Pharmacokinetics Between ABP 234 and Keytruda® (Pembrolizumab) in Participants With Early-stage Non-squamous Non-small Cell Lung Cancer as Adjuvant Treatment Following Resection and Platinum-based Chemotherapy

The primary objective of this study is to demonstrate pharmacokinetic (PK) similarity ABP 234 with pembrolizumab.

Study Overview

• Status: Active, not recruiting
• Conditions: Early-stage Non-squamous Non-small Cell Lung Cancer (NSCLC)
• Intervention / Treatment: Drug: ABP 234; Drug: Pembrolizumab

• Study Type: Interventional
• Enrollment (Actual): 163
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Córdoba, Argentina, X5000HWE
    • Ionc Instituto Oncologico De Cordoba
  • Jujuy Province
    • San Salvador de Jujuy, Jujuy Province, Argentina, 4600
      • Fundacion Ars Medica
  • Santa Fe Province
    • Rosario, Santa Fe Province, Argentina, S2000KZE
      • Instituto de Oncología de Rosario
• Bulgaria
  • Sofia, Bulgaria, 1797
    • University Multiprofile Hospital for Active Treatment Sofiamed
• Chile
  • Santiago, Chile, 2330
    • K2 Oncology
  • Santiago, Chile
    • Icegclinic Research and Care
  • Region Metropolotana
    • Providencia, Region Metropolotana, Chile, 7500859
      • CDIEM - Centro de Investigacion y Especialidades Medicas
  • Región de Valparaíso
    • Viña Del Mar, Región de Valparaíso, Chile, 2540364
      • Centro de Investigaciones Clinicas Vina del Mar Ltda.
    • Viña del Mar, Región de Valparaíso, Chile, 2520598
      • Centro de Investigacin de Enfermedades Respiratorias e Inmunologicas Limitada CIERI
  • Santiago Metropolitan
    • Providencia, Santiago Metropolitan, Chile, 7500921
      • Instituto Oncologico Fundacion Arturo Lopez Perez (FALP)
    • Region Metropolitana, Santiago Metropolitan, Chile, 7560908
      • Centro de Oncología de Precisión
    • Santiago, Santiago Metropolitan, Chile, 7520349
      • Clinica Santa Maria
• France
  • Bayonne, France, 64100
    • Clinique Belharra Ramsay Sante
  • Bordeaux, France, 33075
    • Centre Hospitalier Universitaire de Bordeaux - Hopital Saint - Andre
  • Caen, France, 14076
    • Centre Francois Baclesse
  • Marseille, France, 13003
    • Hôpital Européen Marseille
  • Paris, France, 75018
    • Hopital Bichat, APHP
  • Toulon, France, 83056
    • Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (C.H.I.T.S) - Hopital Sainte Musse
  • Vantoux, France, 57070
    • Hopital Robert Schuman
• Georgia
  • Tbilisi, Georgia, 0114
    • New Hospitals
  • Tbilisi, Georgia, 0112
    • Llc Todua Clinic
• Germany
  • Aschaffenburg, Germany, 63739
    • Studienzentrum Aschaffenburg
  • Essen, Germany, 45276
    • Kliniken Essen Mitte, Evang. Huyssens-Stiftung, Internistische Onkologie und Hmatologie mit integire
• Italy
  • Cona, Italy, 44124
    • Azienda Ospedaliero - Universitaria di Ferrara
  • Cuneo, Italy, 12100
    • Azienda Ospedaliera S. Croce e Carle
  • Florence, Italy, 50134
    • Azienda Ospedaliero-Universitaria Careggi
  • Lucca, Italy, 55043
    • Ospedale Versilia
  • Lucca, Italy, 55100
    • Azienda USL 2 Lucca
  • Monserrato, Italy, 09042
    • AOU Cagliari-Policlinico Universitario Duilio Casula di Monserrato-UOC Oncologia Medica
  • Naples, Italy, 80147
    • ASL Napoli 1 Centro-Ospedale del Mare
  • Peschiera del Garda, Italy, 37019
    • Casa Di Cura Polispecialistica Dott Pederzoli
  • Ravenna, Italy, 48121
    • AUSL Della Romagna - Ospedale S.Maria delle Croci
  • Rozzano, Italy, 20089
    • IRCCS Istituto clinico humanitas - Humanitas Mirasole spa
  • Terni, Italy, 05100
    • Azienda Ospedaliera Santa Maria Terni
  • Varese, Italy, 2110
    • ASST Sette Laghi
• Malaysia
  • 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
      • Hospital Umum Sarawak
• Mexico
  • Puebla City, Mexico, 72530
    • Clinica Integral Internacional de Oncolgia S de RL de CV
  • Guanajuato
    • León, Guanajuato, Mexico, 37178
      • Preparaciones Oncolgicas S.C.
  • Jalisco
    • Zapopan, Jalisco, Mexico, 45070
      • Investigacion Biomedica para el Desarrollo de Nuevos Farmacos SA de CV
  • Mexico City
    • Cuauhtémoc, Mexico City, Mexico, 06760
      • Centro Medico Dalinde
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64000
      • Accelerium Clinical Research
    • Monterrey, Nuevo León, Mexico, 64320
      • Onco Pall Advance Care Oncology Center Sa de CV
    • Monterrey, Nuevo León, Mexico, 64710
      • iCan Oncology Center S.A. de C.V.
• Philippines
  • Manila, Philippines, 1000
    • Philippine General Hospital
  • Cebu
    • Cebu City, Cebu, Philippines, 6000
      • Cebu Doctors University Hospital
  • Davao Del Sur
    • Davao City, Davao Del Sur, Philippines, 8000
      • Davao Doctors Hospital
  • National Capital Region
    • Makati City, National Capital Region, Philippines, 1229
      • Makati 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
• Poland
  • Krakow, Poland, 30-539
    • Specjalistyczne Gabinety Sp. z o.o
  • Przemyśl, Poland, 37-700
    • Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu
  • Sosnowiec, Poland, 41-208
    • GYNCENTRUM Szpital
  • 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
• Romania
  • Cluj-Napoca, Romania, 400641
    • S.C. Medisprof S.R.L
  • Jud. Iasi, Romania, 700106
    • Centrul de Oncologie Euroclinic srl
  • Cluj
    • Cluj-Napoca, Cluj, Romania, 400015
      • Institutul Oncologic Prof. Dr. Ion Chiricuta
  • Timiș County
    • Timișoara, Timiș County, Romania, 300239
      • OncoMed
    • Timișoara, Timiș County, Romania, 300210
      • Oncocenter Oncologie Clinica S.R.L
• Serbia
  • Belgrade, Serbia, 11000
    • Clincial Centre of Serbia
  • Kamenitz, Serbia, 21204
    • Institute for pulmonary diseases of Vojvodina
• South Korea
  • Busan, South Korea, 49241
    • Pusan National University Hospital (PNUH)
  • Incheon, South Korea, 21565
    • Gachon University Gil Medical Center
  • Seoul, South Korea, 03181
    • Kangbuk Samsung Hospital
  • Seoul, South Korea, 02447
    • Kyung Hee University Hospital
  • Seoul, South Korea, 08308
    • Korea University Guro Hospital
  • Seoul, South Korea, 07061
    • Seoul Metropolitan Government - Seoul National University Boramae Medical Center
  • Seoul, South Korea, 05505
    • Asan Medical Center (AMC)
  • 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
  • A Coruna Galicia, Spain, 15009
    • Centro Oncologico de Galicia
  • A Coruña, Spain, 15006
    • Complejo Hospitalario Universitario A Coruña
  • Alicante, Spain, 03203
    • Hospital General Universitario de Elche
  • Badalona, Spain, 08916
    • Institut Catala d'Oncologia Badalona, Hospital Germans Trias I Pujol
  • Barcelona, Spain, 08028
    • Hospital Universitari Quiron Dexeus Barcelona
  • Barcelona, Spain, 08023
    • Hospital Quironsalud Barcelona
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona (Hospital Clinic i Provincial)
  • Barcelona, Spain, 08017
    • Uomi Cancer Center-Clinica Tres Torres
  • Jerez de la Frontera, Spain, 11404
    • Hospital Universitario de Jerez
  • Madrid, Spain, 28040
    • Hospital Universitario San Carlos
  • Madrid, Spain, 28040
    • Hospital Fundación Jiménez Díaz
  • Madrid, Spain, 28922
    • Hospital Universitario Fundación Alcorcón
  • Madrid, Spain, 28050
    • Hospital Universitario Madrid Sanchinarro - Centro Integral Oncologico Clara Campal (CIOCC)
  • Madrid, Spain, 28002
    • Hospital Universitario San Francisco de Asis
  • Madrid, Spain, 28033
    • Clinica MD Anderson International
  • Mataró, Spain, 08304
    • Hospital de Mataró
  • Málaga, Spain, 29004
    • Hospital Quironsalud Malaga
  • Ourense, Spain, 32005
    • Complejo Hospitalario Universitario de Ourense
  • Santiago de Compostela, Spain, 15706
    • Complejo Hospitalario Universitario de Santiago de Compostela
  • Seville, Spain, 41013
    • Hospital Universitario Virgen del Rocio
  • Seville, Spain, 41014
    • Hospital Universitario de Valme
  • Valencia, Spain, 46009
    • Fundacion Instituto Valenciano de Oncologia
  • Valencia, Spain, 46017
    • Hospital Universitario Dr. Peset
  • Valencia, Spain, 46026
    • Universitat de Valencia - Hospital Universitari I Politecnic La Fe de Valencia (Hospital La Fe Bulev
  • Valladolid, Spain, 47003
    • Hospital Clinico Univ Valladolid
• Taiwan
  • Kaohsiung City, Taiwan, 807
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Kaohsiung County, Taiwan, 83301
    • Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
  • Taichung, Taiwan, 40201
    • Chung Shan Medical University Hospital
  • Tainan, Taiwan, 701
    • National Cheng Kung University
  • Taipei, Taiwan, 11217
    • Taipei Veterans 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
    • Bangkoknoi, Bangkok, Thailand, 10700
      • Mahidol University - Siriraj Hospital - Siriraj Clinical Research Center (SICRC)
    • Pathumwan, Bangkok, Thailand, 10330
      • King Chulalongkorn Memorial Hospital, Chulalongkom University
  • Changwat Lampang
    • Muang, Changwat Lampang, Thailand, 52000
      • Lampang Cancer 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
• 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), 06010
    • Gulhane Training and Research Hospital
  • 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
  • Ankara, Turkey (Türkiye), 6490
    • Baskent University Ankara Hospital
  • Bursa, Turkey (Türkiye), 16059
    • Uludag University Faculty Of Medicine
  • Gaziantep, Turkey (Türkiye), 27584
    • Medical Point Gaziantep Hospital
  • Istanbul, Turkey (Türkiye), 34093
    • Bezmialem Foundation University Medical Faculty
  • Sakarya, Turkey (Türkiye), 54290
    • Sakarya University - Faculty of Medicine
  • Ankara
    • Yenimahalle, Ankara, Turkey (Türkiye), 06560
      • Gazi University Faculty of Medicine
  • Edirne
    • İskender, Edirne, Turkey (Türkiye), 22130
      • Trakya University Faculty of Medicine

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Males and females ≥ 18 years of age.
• 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:

• Evidence of disease.
• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABP 234; Participants will receive ABP 234 every 3 weeks (Q3W) for up to 12 months.	Drug: ABP 234; Administered by intravenous (IV) injection.
Active Comparator: Pembrolizumab; Participants will receive pembrolizumab Q3W for up to 12 months.	Drug: Pembrolizumab; Administered by IV injection.

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) Following the First Dose	21 days
AUC at Steady State Between Week 16 and Week 19 (AUCtau_ss)	Weeks 16-19

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum Observed Serum Concentration (Cmax) Following the First Dose (Cmax_dose1)	Up to 65 weeks
Time to Maximum Serum Concentration (Tmax) Following the First Dose (Tmax_dose1)	Up to 65 weeks
Cmax at Steady State (Cmax_ss)	Weeks 16-19
Tmax at Steady State (Tmax_ss)	Weeks 16-19
Trough Serum Concentrations (Ctrough) at Pre-dose of Week 4 (Ctrough_w4)	Week 4 pre-dose
Ctrough at Stead State (Ctrough_ss)	Weeks 16 and 19 pre-dose
Number of Participants with Treatment-emergent Adverse Events	Up to 16 months
Number of Participants with Treatment-emergent Serious Adverse Events	Up to 16 months
Number of Participants with Treatment-emergent Adverse Events of Interest (EOIs)	Up to 16 months
Number of Participants with Andit-drug Antibodies	Baseline and weeks 4, 7, 16, 19, 22, 28, 40, 52, and 65
Disease-free Survival	Up to 65 weeks

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 12, 2024
• Primary Completion (Estimated): December 14, 2026
• Study Completion (Estimated): December 14, 2026

Study Registration Dates

• First Submitted: March 15, 2024
• First Submitted That Met QC Criteria: May 22, 2024
• First Posted (Actual): May 28, 2024

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: NSCLC; Pembrolizumab; Keytruda; ABP 234
• 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: 20230127

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 study will be considered beginning 18 months after the study 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 study.
• IPD Sharing Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies 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
• product manufactured in and exported from the U.S.: Yes