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

Status: Recruiting
Location: See all (128) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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:

‣ Chemotherapy must have begun within 12 weeks after the resection surgery.

⁃ 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).

Locations
Other Locations
Argentina
Ionc Instituto Oncologico De Cordoba
RECRUITING
Córdoba
Instituto de Oncologia de Rosario
RECRUITING
Rosario
Fundacion ARS Medica
RECRUITING
San Salvador De Jujuy
Bulgaria
University Multiprofile Hospital for Active Treatment Sofiamed
RECRUITING
Sofia
Chile
Cdiem
RECRUITING
Providencia
Instituto Oncologico Fundacion Arturo Lopez Perez (FALP)
TERMINATED
Providencia
Centro de Oncologa de Precisin
RECRUITING
Region Metropolitana
Clinica Santa Maria
RECRUITING
Santiago
Icegclinic Research and Care
RECRUITING
Santiago
K2 Oncology
RECRUITING
Santiago
Centro de Investigaciones Clinicas Vina del Mar Ltda.
RECRUITING
Viã±a Del Mar
Centro de Investigacin de Enfermedades Respiratorias e Inmunologicas Limitada CIERI
RECRUITING
Viña Del Mar
France
Clinique Belharra Ramsay Sante
RECRUITING
Bayonne
Centre Hospitalier Universitaire de Bordeaux - Hopital Saint - Andre
RECRUITING
Bordeaux
Centre Francois Baclesse
RECRUITING
Caen
Hopital Europeen Marseille
RECRUITING
Marseille
Hopital Bichat, APHP
RECRUITING
Paris
Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (C.H.I.T.S) - Hopital Sainte Musse
RECRUITING
Toulon
Hopital Robert Schuman
RECRUITING
Vantoux
Georgia
LLC Todua Clinic
RECRUITING
Tbilisi
New Hospitals
RECRUITING
Tbilisi
Germany
Studienzentrum Aschaffenburg
COMPLETED
Aschaffenburg
Kliniken Essen Mitte, Evang. Huyssens-Stiftung, Internistische Onkologie und Hmatologie mit integire
RECRUITING
Essen
Italy
Azienda Ospedaliera Universitaria Di Ferrara
RECRUITING
Cona
Azienda Ospedaliera S. Croce e Carle
RECRUITING
Cuneo
Azienda Ospedaliero-Universitaria Careggi
RECRUITING
Florence
Azienda USL 2 Lucca
RECRUITING
Lucca
Ospedale Versilia
RECRUITING
Lucca
AOU Cagliari-Policlinico Universitario Duilio Casula di Monserrato-UOC Oncologia Medica
RECRUITING
Monserrato
ASL Napoli 1 Centro-Ospedale del Mare
RECRUITING
Napoli
Casa Di Cura Polispecialistica Dott Pederzoli
RECRUITING
Peschiera Del Garda
AUSL Della Romagna - Ospedale S.Maria delle Croci
RECRUITING
Ravenna
IRCCS Istituto clinico humanitas - Humanitas Mirasole spa
RECRUITING
Rozzano
Azienda Ospedaliera Santa Maria Terni
RECRUITING
Terni
ASST Sette Laghi
RECRUITING
Varese
Malaysia
Hospital Canselor Tuanku Muhriz UKM
RECRUITING
Cheras
Raja Perempuan Zainab II Hospital
RECRUITING
Kota Bharu
Hospital Umum Sarawak
RECRUITING
Kuching
Mexico
Centro Medico Dalinde
RECRUITING
Cuauhtémoc
Preparaciones Oncolgicas S.C.
RECRUITING
Leã³n
Accelerium Clinical Research
RECRUITING
Monterrey
Consultorio del Dr. Joaquin Gabriel Reinoso Toledo
RECRUITING
Monterrey
iCan Oncology Center S.A. de C.V.
RECRUITING
Monterrey
Clinica Integral Internacional de Oncolgia S de RL de CV
RECRUITING
Puebla City
Investigacion Biomedica para el Desarrollo de Nuevos Farmacos SA de CV
RECRUITING
Zapopan
Philippines
Riverside Medical Center Inc
RECRUITING
Bacolod City
Cebu Doctors University Hospital
RECRUITING
Cebu City
Davao Doctors Hospital
RECRUITING
Davao City
Makati Medical Center
RECRUITING
Makati City
Philippine General Hospital
RECRUITING
Manila
Veterans Memorial Medical Center
RECRUITING
Quezon City
Poland
Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy
RECRUITING
Bydgoszcz
Specjalistyczne Gabinety Sp. z o.o
RECRUITING
Krakow
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
RECRUITING
Lublin
Warminsko Mazurskie Centrum Chorob Pluc w Olsztynie
RECRUITING
Olsztyn
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu
RECRUITING
Przemyśl
Gyncentrum Szpital
RECRUITING
Sosnowiec
Republic of Korea
Pusan National University Hospital (PNUH)
RECRUITING
Busan
Chungbuk National University Hospital
RECRUITING
Cheongju-si
Gachon University Gil Medical Center
RECRUITING
Incheon
Jeonbuk National University Hospital
RECRUITING
Jeonju
Asan Medical Center (AMC)
RECRUITING
Seoul
Kangbuk Samsung Hospital
RECRUITING
Seoul
Korea University Guro Hospital
RECRUITING
Seoul
Kyung Hee University Hospital
RECRUITING
Seoul
Seoul Metropolitan Government - Seoul National University Boramae Medical Center
RECRUITING
Seoul
Ajou University Hospital
RECRUITING
Suwon
The Catholic University Of Korea, St. Vincent's Hospital
RECRUITING
Suwon
Romania
Institutul Oncologic Prof. Dr. Ion Chiricuta
RECRUITING
Cluj-napoca
S.C. Medisprof S.R.L
RECRUITING
Cluj-napoca
Centrul de Oncologie Euroclinic srl
RECRUITING
Jud. Iasi
Oncocenter Oncologie Clinica S.R.L
RECRUITING
Timișoara
Oncomed
RECRUITING
Timișoara
Serbia
Clincial Centre of Serbia
RECRUITING
Belgrade
Institute for Pulmonary Diseases of Vojvodina
RECRUITING
Kamenitz
Spain
Complejo Hospitalario Universitario A Coruna
RECRUITING
A Coruña
Centro Oncologico de Galicia
RECRUITING
A Coruna Galicia
Hospital General Universitario de Elche
RECRUITING
Alicante
Institut Catala d'Oncologia Badalona, Hospital Germans Trias I Pujol
RECRUITING
Badalona
Hospital Clinic de Barcelona (Hospital Clinic i Provincial)
RECRUITING
Barcelona
Hospital Quironsalud Barcelona
RECRUITING
Barcelona
Hospital Universitari Quiron Dexeus Barcelona
RECRUITING
Barcelona
UOMI Cancer Center-Clinica Tres Torres
RECRUITING
Barcelona
Hospital Universitario de Jerez
RECRUITING
Jerez De La Frontera
Hospital Quironsalud Malaga
RECRUITING
Mã¡laga
Clinica MD Anderson International
RECRUITING
Madrid
Hospital Clnico San Carlos (HCSC)
RECRUITING
Madrid
Hospital Fundacion Jimenez Diaz
RECRUITING
Madrid
Hospital Universitario Fundacion Alcorcon
RECRUITING
Madrid
Hospital Universitario Madrid Sanchinarro - Centro Integral Oncologico Clara Campal (CIOCC)
RECRUITING
Madrid
Hospital Universitario San Francisco de Asis
RECRUITING
Madrid
Hospital De Mataro
RECRUITING
Mataró
Complejo Hospitalario Universitario de Ourense
RECRUITING
Ourense
Complejo Hospitalario Universitario De Santiago De Compostela
RECRUITING
Santiago De Compostela
Hospital Universitario De Valme
RECRUITING
Seville
Hospital Universitario Virgen del Rocio
RECRUITING
Seville
Fundacion Instituto Valenciano de Oncologia
RECRUITING
Valencia
Hospital Universitario Dr. Peset
RECRUITING
Valencia
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulev
RECRUITING
Valencia
Hospital Clinico Univ Valladolid
RECRUITING
Valladolid
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
RECRUITING
Kaohsiung County
Chung Shan Medical University Hospital
RECRUITING
Taichung
National Cheng Kung University
RECRUITING
Tainan
National Taiwan University Hospital (NTUH)
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Thailand
Faculty of Medicine Vajira Hospital, Navamindradhiraj University
RECRUITING
Bangkok
Mahidol University - Siriraj Hospital - Siriraj Clinical Research Center (SICRC)
RECRUITING
Bangkoknoi
Prince Of Songkla Hospital, Prince Of Songkhla University
RECRUITING
Hat Yai
Lampang Cancer Hospital
RECRUITING
Muang
Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University
RECRUITING
Muang
Naresuan University Hospital
RECRUITING
Muang
King Chulalongkorn Memorial Hospital, Chulalongkom University
RECRUITING
Pathumwan
Turkey
Adana City Training and Research Hospital
RECRUITING
Adana
Medical Park Seyhan Hospital
RECRUITING
Adana
Ankara Bilkent City Hospital
RECRUITING
Ankara
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi
RECRUITING
Ankara
Baskent University Ankara Hospital
RECRUITING
Ankara
Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
RECRUITING
Ankara
Gulhane Training and Research Hospital
RECRUITING
Ankara
Liv Hospital Ankara
RECRUITING
Ankara
Memorial Ankara Hospital
RECRUITING
Ankara
Uludag University Faculty of Medicine
RECRUITING
Bursa
Medical Point Gaziantep Hospital
RECRUITING
Gaziantep
Trakya University Faculty of Medicine
RECRUITING
İskender
Bezmialem Foundation University Medical Faculty
RECRUITING
Istanbul
Sakarya University - Faculty of Medicine
RECRUITING
Sakarya
Gazi University Faculty of Medicine
RECRUITING
Yenimahalle
Contact Information
Primary
Amgen Call Center
medinfo@amgen.com
866-572-6436
Time Frame
Start Date: 2024-09-12
Estimated Completion Date: 2026-12-14
Participants
Target number of participants: 154
Treatments
Experimental: ABP 234
Participants will receive ABP 234 every 3 weeks (Q3W) for up to 12 months.
Active_comparator: Pembrolizumab
Participants will receive pembrolizumab Q3W for up to 12 months.
Sponsors
Leads: Amgen

This content was sourced from clinicaltrials.gov