A Study to Compare ABP 234 and Keytruda® (Pembrolizumab) in Participants With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer

NCT06311721 | Active Not Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: 202100332023-508336-572024-514304-14-00
• Study Type: interventional
• Target: 315
• Locations: 23 countries
• Sites: 218

Brief Summary

The primary objective of this trial is to demonstrate pharmacokinetic (PK) similarity of ABP 234 compared with the pembrolizumab reference product (Keytruda®).

Conditions

Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (6)

• Area under the serum concentration-time curve (AUC) from time 0 to 21 days (AUC21d) of ABP 234

  21 days

• AUC21d of pembrolizumab (US)

  21 days

• AUC21d of pembrolizumab (EU)

  21 days

• AUC at steady state between Week 16 and Week 19 (AUCtau_ss) of ABP 234

  Week 16 through Week 19

• AUCtau_ss of pembrolizumab (US)

  Week 16 through Week 19

• AUCtau_ss of pembrolizumab (EU)

  Week 16 through Week 19

Secondary Outcomes (28)

• Objective response (OR)

  Week 49

• OR

  Week 13

• OR

  Week 31

• Duration of response (DOR)

  Up to 2.5 years

• Progression-free survival (PFS)

  Up to 2.5 years

Study Arms (3)

ABP 234

EXPERIMENTAL

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.

Drug: ABP 234

Pembrolizumab (US)

EXPERIMENTAL

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.

Drug: Pembrolizumab (US)

Pembrolizumab (EU)

EXPERIMENTAL

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.

Drug: Pembrolizumab (EU)

Interventions

ABP 234 DRUG

Intravenous administration

ABP 234

Pembrolizumab (US) DRUG

Intravenous administration

Also known as: Keytruda®

Pembrolizumab (US)

Pembrolizumab (EU) DRUG

Intravenous administration

Also known as: Keytruda®

Pembrolizumab (EU)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age.
• Histologically or cytologically confirmed stage IV non-squamous Non-Small Cell Lung Cancer (NSCLC).
• Participant has no prior systemic treatment for advanced disease.
• Measurable disease according to RECIST v1.1.
• Tumor tissue from the resected site of disease must be available for biomarker analyses in order to be randomized.
• Eastern Cooperative Oncology Group performance status score 0 or 1.
• 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
• Have a life expectancy of at least 3 months.

You may not qualify if:

• Small cell lung cancer (SCLC) or mixed SCLC/NSCLC histology or squamous cell carcinoma.
• Participant has active central nervous system metastases not previously treated.
• Participant has active or known immune-mediated disorders.
• Participant has received prior systemic cytotoxic chemotherapy, immunotherapy (including PD-1/PD-L1), anti-neoplastic biological therapy, or targeted therapy for advanced/metastatic disease.
• Known hypersensitivity to monoclonal antibodies or to any of the excipients of the study drug, or to any component of cisplatin, carboplatin, or pemetrexed.

Sponsors & Collaborators

• Amgen: lead

Study Sites (218)

Precision NextGen Oncology and Research Center

Beverly Hills, California, 90212, United States

Location

TOI Clinical Research

Cerritos, California, 90703, United States

Location

Cancer and Blood Specialty Clinic (CBSC)

Los Alamitos, California, 90720-3309, United States

Location

Valkyrie Clinical Trials

Los Angeles, California, 90067, United States

Location

PIH Health Hospital

Whittier, California, 90602, United States

Location

Millennium Oncology - Hollywood

Hollywood, Florida, 33024, United States

Location

BRCR Medical Center Inc.

Tamarac, Florida, 33321, United States

Location

Accellacare Duly

Plainfield, Illinois, 60585, United States

Location

Accellacare of McFarland

Ames, Iowa, 50010, United States

Location

Detroit Clinical Research Center, PC

Farmington Hills, Michigan, 48334, United States

Location

North Shore Hematology-Oncology Associates P.C. d/b/a New York Cancer & Blood Specialists

Shirley, New York, 11967, United States

Location

Gabrail Cancer Center Research

Canton, Ohio, 44718, United States

Location

Millennium Research and Clinical Development, LLC

Houston, Texas, 77090, United States

Location

Texas Oncology, P.A

San Antonio, Texas, 78217, United States

Location

Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

Wytheville, Virginia, 24382, United States

Location

Instituto de Investigaciones Clinicas Mar del Plata

Mar del Plata, Buenos Aires, B7600, Argentina

Location

Centro de Investigacion Pergamino SA

Pergamino, Buenos Aires, B2700CPM, Argentina

Location

Fundacion ARS Medica

San Salvador de Jujuy, Jujuy Province, 4600, Argentina

Location

Sanatorio Britanico De Rosario

Rosario, Santa Fe Province, S2000CVB, Argentina

Location

Hospital Provincial del Centenario

Rosario, Santa Fe Province, S2002KDT, Argentina

Location

IONC - Instituto Oncologico de Cordoba

Córdoba, 5001, Argentina

Location

Klinikum Klagenfurt am Woerthersee

Klagenfurt, 9020, Austria

Location

Ordensklinikum Linz GmbH Elisabethinen

Linz, 4020, Austria

Location

CRIO - Centro Regional Integrado de Oncologia

Fortaleza, Ceará, 60335-480, Brazil

Location

OC Oncoclinicas Oncovida

Brasília, Destrito Federal, 70390-150, Brazil

Location

Centro de Pesquisas Clinicas em Oncologia (CPCO)/HECI

Cachoeiro de Itapemirim, Espírito Santo, 29308-014, Brazil

Location

Associacao Feminina de Educacao e Combate ao Cancer(AFECC) - Hospital Santa Rita

Vitória, Espírito Santo, 29043-260, Brazil

Location

Hospital Santa Izabel, Santa Casa de Misericordia da Bahia

Salvador, Estado de Bahia, 40050-410, Brazil

Location

Cetus Oncologia S.A. Unidade Belo Horizonte

Belo Horizonte, Minas Gerais, 30110-022, Brazil

Location

Nucleo de Ensino Pesquisa e Inovacao Mario Penna

Belo Horizonte, Minas Gerais, 30380-472, Brazil

Location

Fundacao Sao Francisco Xavier - Hospital Marcio Cunha (HMC) - Unidade I

Ipatinga, Minas Gerais, 35162-189, Brazil

Location

Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner

Curitiba, Paraná, 81520-060, Brazil

Location

Instituto de Cancer de Londrina - Hospital do Cancer de Londrina - HCL

Londrina, Paraná, 86015-520, Brazil

Location

Liga Contra o Cancer

Natal, Rio Grande do Norte, 59062-000, Brazil

Location

Hospital Tacchini

Bento Gonçalves, Rio Grande do Sul, 95700-000, Brazil

Location

Oncosite Centro De Pesquisa Clinica Em Oncologia

Ijuí, Rio Grande do Sul, 98700-000, Brazil

Location

Hospital Bruno Born

Lajeado, Rio Grande do Sul, 95900-000, Brazil

Location

Hospital da Cidade de Passo Fundo - HCPF

Passo Fundo, Rio Grande do Sul, 99010-260, Brazil

Location

Unidade de Pesquisa Clinica em Oncologia Ltda (UPCO) (Clinica Lacks)

Pelotas, Rio Grande do Sul, 96020-080, Brazil

Location

Centro de Pesquisa em Oncologia - Hospital Sao Lucas da PUC Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

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, 90160-093, Brazil

Location

Centro de Oncologia de Santa Catarina Ltda / Supera Oncologia

Chapecó, Santa Catarina, 89801-355, Brazil

Location

CEPEN Centro de Pesquisa e Ensino em Saude de Santa Catarina

Florianópolis, Santa Catarina, 88020-210, Brazil

Location

Instituto Joinvillense de Hematologia e Oncologia SS Ltda - Clinica de Hematologia e Oncologia

Joinville, Santa Catarina, 89201-260, Brazil

Location

Fundacao Pio XII - Hospital de Cancer de Barretos

Barretos, São Paulo, 14784-400, Brazil

Location

Centro de Pesquisa Sao Lucas

Campinas, São Paulo, 13060-904, Brazil

Location

Centro Oncologico Mogi das Cruzes

Mogi das Cruzes, São Paulo, 08730-500, Brazil

Location

Instituto Ribeiraopretano de Combate ao Cancer (IRPCc) - IRPCC

Ribeirão Preto, São Paulo, 14015-130, Brazil

Location

Faculdade de Medicina do ABC - Centro de Estudos e Pesqulsas de Hematologia e Oncologia

Santo André, São Paulo, 09060-0650, Brazil

Location

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, 15090-000, Brazil

Location

Hospital Nossa Senhora das Gracas

Canoas, 92030-000, Brazil

Location

CIONC - Centro Integrado de Oncologia de Curitiba

Curitiba, 81480-580, Brazil

Location

Centro Integrado de Pesquisa em Oncologia - Hospital Nossa Senhora da Conceio

Porto Alegre, 91350-200, Brazil

Location

Instituto Nacional de Cancer (INCA)

Rio de Janeiro, 20231-050, Brazil

Location

Instituto Americas - Ensino, Pesquisa e Inovacao

Rio de Janeiro, 22775-001, Brazil

Location

Oncoclinicas Rio de Janeiro S.A (Centro de Tratamento de Tumores Botafogo)

Rio de Janeiro - RJ, 22250-905, Brazil

Location

Instituto D'Or de Pesquisa e Ensino - Hospital Sao Rafael

Salvador, 41253- 190, Brazil

Location

Hospital Alemao Oswaldo Cruz (HAOC)

São Paulo, 01327-001, Brazil

Location

Instituto Brasileiro de Controle do Cancer - IBCC Oncologia

São Paulo, 04014-002, Brazil

Location

University Multi-Profile Hospital for Active Treatment (UMHAT) St. Ivan Rilski

Sofia, Sofia-Grad, 1431, Bulgaria

Location

MHAT Dobrich AD

Dobrich, 5500, Bulgaria

Location

University Multiprofile Hospital for Active Treatment Sofiamed

Sofia, 1797, Bulgaria

Location

CDIEM - Centro de Investigacion y Especialidades Medicas

Providencia, Santiago Metropolitan, 7500859, Chile

Location

Centro de Oncologa de Precisin

Region Metropolitana, Santiago Metropolitan, 7560908, Chile

Location

Clinica Santa Maria

Santiago, Santiago Metropolitan, 7520349, Chile

Location

Oncocentro APYS

Viña del Mar, Valparaiso, 2520598, Chile

Location

Centro de Investigaciones Clinicas Vina del Mar Ltda.

Viña del Mar, Valparaiso, 2540364, Chile

Location

K2 Oncology

Santiago, 2209, Chile

Location

Icegclinic Research and Care

Santiago, 8240000, Chile

Location

Centre Hospitalier Universitaire de Bordeaux - Hopital Saint - Andre

Bordeaux, 33075, France

Location

Centre Hospitalier Universitaire (CHU) De Limoges Hopital Dupuytren

Limoges, 87000, France

Location

Hopital Europeen Marseille

Marseille, 13003, France

Location

Clinique Clementville-Gcs Centre De Cancerologie Du Grand Montpellier

Montpellier, 34070, France

Location

Centre Hospitalier Universitaire de Nimes (CHU) - Hopital Universitaire Caremeau

Nîmes, 30029, France

Location

Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (C.H.I.T.S) - Hospital Font-Pre

Toulon, 83000, France

Location

Clinique Teissier

Valenciennes, 59300, France

Location

Hopital Robert Schuman

Vantoux, 57070, France

Location

High Technology Hospital Medcenter LTD

Batumi, 6000, Georgia

Location

Israel-Georgian Medical Research Clinic Healthycore

Tbilisi, 0112, Georgia

Location

LLC Todua Clinic

Tbilisi, 0112, Georgia

Location

TIM -Tbilisi Institute of Medicine

Tbilisi, 0160, Georgia

Location

New Hospitals

Tbilisi, 0162, Georgia

Location

Medulla - Clinics And Medical Centers

Tbilisi, 0168, Georgia

Location

Evang. Kliniken Essen Mitte GmbH

Essen, 45136, Germany

Location

Studienzentrum Aschaffenburg

Hösbach, 63768, Germany

Location

Haematologie, Onkologie und Palliativmedizin, Tagesklinik Landshut

Landshut, 84036, Germany

Location

FEK - Friedrich-Ebert-Krankenhaus Neumuenster GmbH

Neumünster, 24534, Germany

Location

Azienda Ospedaliero - Universitaria di Ferrara

Cona, 44124, Italy

Location

Azienda Socio Sanitaria Territoriale di Cremona

Cremona, 26100, Italy

Location

Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico Di Milano

Milan, 20122, Italy

Location

UOC Oncoematologia AOU Luigi Vanvitelli

Naples, 80131, Italy

Location

ASL Napoli 1 Centro-Ospedale del Mare

Naples, 80147, Italy

Location

AUSL Della Romagna - Ospedale S.Maria delle Croci

Ravenna, 48121, Italy

Location

S.C. Oncologia Medica-Presidio Ospedaliero Sondrio

Sondrio, 23100, Italy

Location

Azienda Ospedaliera Santa Maria Terni

Terni, 05100, Italy

Location

Japan Community Healthcare Organization Chukyo Hospital

Nagoya, Aichi-ken, 457-8510, Japan

Location

Funabashi Municipal Medical Center

Funabashi-shi, Chiba, 273-8588, Japan

Location

Kyushu University Hospital

Fukuoka, Fukuoka, 812-8582, Japan

Location

Aso Iizuka Hospital

Iizuka-shi, Fukuoka, 820-8505, Japan

Location

Japanese Red Cross Maebashi Hospital

Maebashi, Gunma, 371-0811, Japan

Location

Chugoku Central Hospital

Fukuyama, Hiroshima, 720-0001, Japan

Location

Hiroshima Prefectural Hospital

Hiroshima, Hiroshima, 734-8530, Japan

Location

Asahikawa Medical University Hospital

Asahikawa, Hokkaido, Japan, 078-8510, Japan

Location

Hyogo Prefectural Amagasaki General Medical Center

Amagasaki, Hyōgo, 660-8550, Japan

Location

Nippon Medical School Musashikosugi Hospital

Kawasaki-shi, Kanagawa, 211-8533, Japan

Location

Yokohama City University Hospital

Yokohama, Kanagawa, 236-0004, Japan

Location

Yokosuka Kyosai Hospital

Yokosuka, Kanagawa, 238-8558, Japan

Location

Social Welfare Organization Imperial Gift Foundation, Inc. Saiseikai Kumamoto Hospital

Kumamoto, Kumamoto, 861-4193, Japan

Location

Osaki Citizen Hospital

Ōsaki, Miyagi, 989-6183, Japan

Location

Miyazaki Prefectural Miyazaki Hospital

Miyazaki, Miyazaki, 880-8510, Japan

Location

Shinshu University Hospital

Matsumoto, Nagano, 390-8621, Japan

Location

NHO Kinki Chuo Chest Medical Center

Sakai, Osaka Japan, 591-8555, Japan

Location

Kawaguchi Municipal Medical Center

Kawaguchi-shi, Saitama, 333-0833, Japan

Location

Seirei Hamamatsu General Hospital

Hamamatsu, Shizuoka, 430-8558, Japan

Location

Hamamatsu Medical Center

Hamamatsu, Shizuoka, Japan, 432-8580, Japan

Location

Ome Medical Center

Ome-shi, Tokyo, 198-0042, Japan

Location

Hospital Sultanah Bahiyah

Alor Star, Kedah, 05460, Malaysia

Location

Raja Perempuan Zainab II Hospital

Kota Bharu, Kelantan, 15586, Malaysia

Location

Hospital Canselor Tuanku Muhriz UKM

Cheras, Kuala Lumpur, 56000, Malaysia

Location

Sarawak General Hospital

Kuching, Sarawak, 93586, Malaysia

Location

University of Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

Location

Hospital III Goyeneche

Cercado, Arequipa, 04001, Peru

Location

Instituto Nacional De Enfermedades Neoplasicas

Surquillo, Lima, Peru, 15038, Peru

Location

Hospital IV - Alberto Sabogal Sologuren Red Asistencial Sabogal

Bellavista, Provincia Constitucional del Callao, 07001, Peru

Location

Centro Medico Monte Carmelo

Arequipa, 04001, Peru

Location

Clinic Vallesur Arequipa

Arequipa, 04001, Peru

Location

Hospital de Apoyo Maria Auxiliadora

Lima, 15801, Peru

Location

Clnica San Antonio

Trujillo, 13008, Peru

Location

Cebu Doctors University Hospital

Cebu City, Cebu, 6000, Philippines

Location

Chong Hua Hospital

Cebu City, Cebu, 6000, Philippines

Location

Perpetual Succour Hospital

Cebu City, Central Visayas, 6000, Philippines

Location

Davao Doctors Hospital

Davao City, Davao Del Sur, 8000, Philippines

Location

West Visayas State University Medical Center

Iloilo City, Iloilo, 5000, Philippines

Location

Asian Hospital And Medical Center

Muntinlupa, National Capital Region, 1780, Philippines

Location

Veterans Memorial Medical Center

Quezon City, National Capital Region, 1110, Philippines

Location

St. Lukes Medical Center

Quezon City, NCR, 1102, Philippines

Location

Riverside Medical Center Inc

Bacolod City, Negros Occidental, 6100, Philippines

Location

St. Paul's Hospital of Iloilo, Inc.

Iloilo City, Western Visayas, 5000, Philippines

Location

Philippine General Hospital

Manila, 1000, Philippines

Location

Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

Location

Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

Lublin, Lublin Voivodeship, 20-954, Poland

Location

Warminsko Mazurskie Centrum Chorob Pluc w Olsztynie

Olsztyn, Warmian-Masurian Voivodeship, 10-357, Poland

Location

Instytut MSF Sp. z o.o.

Lodz, 90-302, Poland

Location

NZOZ Neuromed M. i M. Nastaj Sp.P

Lublin, 20-064, Poland

Location

Med-Polonia Sp. z o.o.

Poznan, 60-693, Poland

Location

Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o.

Słupsk, 76-200, Poland

Location

Clincial Centre of Serbia

Belgrade, 11000, Serbia

Location

Institute for Pulmonary Diseases of Vojvodina

Kamenitz, 21204, Serbia

Location

University Clinical Centre of Kragujevac

Kragujevac, 34000, Serbia

Location

GVI Oncology, Langenhoven Drive Oncology Centre

Port Elizabeth, Eastern Cape, 6045, South Africa

Location

University of Pretoria and Steve Biko Academic Hospital Complex

Pretoria, Gauteng, 0002, South Africa

Location

Life Wilgers Hospital Wilgers Oncology Centre

Pretoria, Gauteng, 0040, South Africa

Location

Dr W M Szpak Inc - Rainbow Oncology

Athlone Park, KwaZulu-Natal, 4126, South Africa

Location

Abraham Oncology

Richards Bay, KwaZulu-Natal, 3900, South Africa

Location

The Catholic University Of Korea, St. Vincent's Hospital

Suwon, Gyeonggi-do, 16247, South Korea

Location

Ajou University Hospital

Suwon, Gyeonggi-do, 16499, South Korea

Location

Jeonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

Location

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, 28644, South Korea

Location

Kyung Hee University Hospital

Seoul, 02447, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Location

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, 06591, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Hospital General Universitario de Elche

Alicante, 03203, Spain

Location

UOMI Cancer Center-Clinica Tres Torres

Barcelona, 08017, Spain

Location

Hospital Quironsalud Barcelona

Barcelona, 08023, Spain

Location

Complejo Hospitalario de Jaen (University Hospital Ciudad De Jaen)

Jaén, 23007, Spain

Location

Hospital Universitario San Francisco de Asis

Madrid, 28002, Spain

Location

Hospital Unifersitario Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

Hospital Universitario Fundacion Alcorcon

Madrid, 28922, Spain

Location

Hospital De Mataro

Mataró, 08304, Spain

Location

Hospital Quironsalud Malaga

Málaga, 29004, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, 33011, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Location

Hospital Universitario Nuestra Senora De Valme

Seville, 41014, Spain

Location

Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulev

Valencia, 46026, Spain

Location

Hospital Quironsalud Valencia

Valencia, Â 46010, Spain

Location

Tri-Service General Hospital

Neihu, Taipei, 114202, Taiwan

Location

National Taiwan University Hospital (NTUH)

Taipei, Zhongzheng Dist, 10050, Taiwan

Location

Dalin Tzu chi General Hospital - Buddhist Tzu chi Medical Foundation

Chiayi City, 62247, Taiwan

Location

National Taiwan University Hospital Yun-Lin Branch

Douliu, 640, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 80756, Taiwan

Location

Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital

Kaohsiung County, 83301, Taiwan

Location

Taipei Medical University (TMU) - Shuang Ho Hospital (SHH)

New Taipei City, 235, Taiwan

Location

Chung Shan Medical University Hospital

Taichung, 402, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 70403, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Mahidol University - Siriraj Hospital - Siriraj Clinical Research Center (SICRC)

Bangkoknoi, Bangkok, 10700, Thailand

Location

Chiangrai Prachanukroh Hospital

Muang, Changwat Chiang Rai, 57000, Thailand

Location

Naresuan University Hospital

Muang, Changwat Phitsanulok, 65000, Thailand

Location

Prince Of Songkla Hospital, Prince Of Songkhla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University

Muang, Chiang Mai, 52000, Thailand

Location

Chulabhorn Hospital

Talat Bang Khen, Lak Si, 10210, Thailand

Location

Faculty of Medicine Vajira Hospital, Navamindradhiraj University

Bangkok, 10300, Thailand

Location

King Chulalongkorn Memorial Hospital, Chulalongkom University

Bangkok, 10330, Thailand

Location

Adana Ortadogu Hospital

Seyhan, Adana, 67055, Turkey (Türkiye)

Location

Gulhane Training and Research Hospital

Keçiören, Ankara, 06010, Turkey (Türkiye)

Location

Gazi University Faculty of Medicine

Yenimahalle, Ankara, 06560, Turkey (Türkiye)

Location

Trakya University Faculty of Medicine

İskender, Edirne, 22130, Turkey (Türkiye)

Location

Ondokuz Mayis University Health Practice and Research Hospital

Atakum, Samsun, 55280, Turkey (Türkiye)

Location

Medical Park Seyhan Hospital

Adana, 01230, Turkey (Türkiye)

Location

Adana City Training and Research Hospital

Adana, 4522, Turkey (Türkiye)

Location

Ankara Universitesi Tip Fakultesi Cebeci Hastanesi

Ankara, 06100, Turkey (Türkiye)

Location

Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Ankara, 06200, Turkey (Türkiye)

Location

Memorial Ankara Hospital

Ankara, 06520, Turkey (Türkiye)

Location

Liv Hospital Ankara

Ankara, 06680, Turkey (Türkiye)

Location

Ankara Bilkent City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Uludag University Medical Faculty

Bursa, 16059, Turkey (Türkiye)

Location

Medical Point Gaziantep Hospital

Gaziantep, 27584, Turkey (Türkiye)

Location

Bezmialem Foundation University Medical Faculty

Istanbul, 34093, Turkey (Türkiye)

Location

Yeditepe University Kosuyolu Hospital

Istanbul, 34718, Turkey (Türkiye)

Location

Istanbul Medeniyet University Medical Faculty

Istanbul, 34720, Turkey (Türkiye)

Location

Kocaeli Universitesi Tip Fakultesi

Kocaeli, 41380, Turkey (Türkiye)

Location

Necmettin Erbakan University Meram Medical Faculty

Konya, 42080, Turkey (Türkiye)

Location

Sakarya Universitesi Tip Fakultesi

Sakarya, 54290, Turkey (Türkiye)

Location

Namik Kemal Universitesi Hastanesi

Tekirdağ, 59100, Turkey (Türkiye)

Location

Nottingham University Hospitals NHS Trust - Nottingham City Hospital

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Interventions

pembrolizumab

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 15, 2024
• Study Start: September 9, 2024
• Primary Completion (Estimated): January 10, 2028
• Study Completion (Estimated): April 24, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this trial will be considered beginning 18 months after the trial 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 trial.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen trial/trials 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.

Locations

TU (21); US (15); PE (7); DE (4); FR (8); GE (6); TH (8); JP (21); PH (11); MY (5); AR (6); SE (3); BR (36); KR (9); PL (7); IT (8); TW (11); GB (1); CL (7); AU (2); BU (3); ZA (5); ES (14)