RecruitingPhase 3NCT06430866

Pharmacokinetic Similarity Between ABP 234 and Keytruda® (Pembrolizumab)

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

Sponsor

Amgen

Enrollment

154 participants

Start Date

Sep 12, 2024

Study Type

INTERVENTIONAL

Conditions

Early-stage Non-squamous Non-small Cell Lung Cancer (NSCLC)

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a biosimilar version of pembrolizumab (a cancer immunotherapy drug) works the same way as the original brand-name Keytruda in people with a type of lung cancer that has been surgically removed. **You may be eligible if...** - You are 18 or older - You have been diagnosed with non-squamous non-small cell lung cancer (NSCLC) - Your cancer was at stage IB (tumor ≥4 cm), II, or IIIA and was fully removed by surgery - You completed platinum-based chemotherapy that started within 12 weeks of your surgery and finished at least 3 but no more than 12 weeks ago - Your general health and ability to function are good (ECOG score of 0 or 1) - Your tumor has been tested for certain markers (PD-L1, EGFR, ALK, ROS-1) **You may NOT be eligible if...** - Your cancer has returned or spread - You have certain genetic mutations (EGFR or ALK-positive tumors) - You have significant other health conditions affecting your heart, liver, kidneys, or immune system - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGABP 234

Administered by intravenous (IV) injection.

DRUGPembrolizumab

Administered by IV injection.

Locations(128)

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

Clinica Santa Maria

Santiago, Santiago Metropolitan, Chile

Fundacion ARS Medica

San Salvador de Jujuy, Jujuy Province, Argentina

Instituto de Oncologia de Rosario

Rosario, Santa Fe Province, Argentina

Ionc Instituto Oncologico De Cordoba

Córdoba, Argentina

CDIEM - Centro de Investigacion y Especialidades Medicas

Providencia, Region Metropolotana, Chile

Centro de Investigaciones Clinicas Vina del Mar Ltda.

ViÃ±a 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 Oncologia de Precision

Region Metropolitana, Santiago Metropolitan, Chile

Clinique Belharra Ramsay Sante

Bayonne, France

Centre Hospitalier Universitaire de Bordeaux - Hopital Saint - Andre

Bordeaux, France

Centre Francois Baclesse

Caen, 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 Ospedaliero - Universitaria di Ferrara

Cona, Italy

Azienda Ospedaliera S. Croce e Carle

Cuneo, 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

University Multiprofile Hospital for Active Treatment Sofiamed

Sofia, Bulgaria

Hopital Europeen Marseille

Marseille, France

Hopital Bichat, APHP

Paris, France

Azienda Ospedaliero-Universitaria Careggi

Florence, Italy

IRCCS Istituto clinico humanitas - Humanitas Mirasole spa

Rozzano, Italy

Azienda Ospedaliera Santa Maria Terni

Terni, Italy

ASST Sette Laghi

Varese, Italy

Raja Perempuan Zainab II Hospital

Kota Bharu, Kelantan, Malaysia

Hospital Canselor Tuanku Muhriz UKM

Cheras, Kuala Lumpur, Malaysia

Hospital Umum Sarawak

Kuching, Sarawak, Malaysia

Preparaciones Oncolgicas S.C.

LeÃ³n, Guanajuato, Mexico

Investigacion Biomedica para el Desarrollo de Nuevos Farmacos SA de CV

Zapopan, Jalisco, Mexico

Centro Medico Dalinde

Cuauhtémoc, Mexico City, Mexico

Kyung Hee University Hospital

Seoul, South Korea

Kangbuk Samsung Hospital

Seoul, South Korea

Specjalistyczne Gabinety Sp. z o.o

Krakow, Poland

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

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

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

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

Accelerium Clinical Research

Monterrey, Nuevo León, Mexico

Philippine General Hospital

Manila, Philippines

Gachon University Gil Medical Center

Incheon, South Korea

Hospital Universitario de Jerez

Jerez de la Frontera, Spain

Hospital Clinic de Barcelona (Hospital Clinic i Provincial)

Barcelona, Spain

Hospital De Mataro

Mataró, Spain

Hospital Quironsalud Malaga

MÃ¡laga, Spain

Complejo Hospitalario Universitario de Ourense

Ourense, Spain

Complejo Hospitalario Universitario De Santiago De Compostela

Santiago de Compostela, Spain

Hospital Clinico Univ Valladolid

Valladolid, Spain

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

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

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)

Faculty of Medicine Vajira Hospital, Navamindradhiraj University

Bangkok, Thailand

Hospital Universitario Virgen del Rocio

Seville, Spain

Hospital Universitario De Valme

Seville, Spain

National Taiwan University Hospital (NTUH)

Taipei, Zhongzheng Dist, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

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

Pusan National University Hospital (PNUH)

Busan, South Korea

Onco Pall Advance Care Oncology Center Sa de CV

Monterrey, Nuevo León, Mexico

iCan Oncology Center S.A. de C.V.

Monterrey, Nuevo León, Mexico

Hospital Universitario San Francisco de Asis

Madrid, Spain

Clinica MD Anderson International

Madrid, Spain

Hospital Fundacion Jimenez Diaz

Madrid, Spain

Hospital Unifersitario Fundacion Jimenez Diaz

Madrid, Spain

Hospital Universitario Madrid Sanchinarro - Centro Integral Oncologico Clara Campal (CIOCC)

Madrid, Spain

Hospital Universitario Fundacion Alcorcon

Madrid, Spain

UOMI Cancer Center-Clinica Tres Torres

Barcelona, Spain

Hospital Quironsalud Barcelona

Barcelona, Spain

Hospital Universitari Quiron Dexeus Barcelona

Barcelona, Spain

K2 Oncology

Santiago, Chile

Icegclinic Research and Care

Santiago, Chile

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NCT06430866