AzTrials
AzTrials

Advanced or Metastatic Non-squamous Non-Small Cell Lung CancerPhase 3NCT06311721

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

A Phase 3 study testing ABP 234, Pembrolizumab (US) and Pembrolizumab (EU) in people with Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer, run by Amgen at 218 sites in 23 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 99 years
What is being tested?
ABP 234, Pembrolizumab (US) and Pembrolizumab (EU)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
315 participants
Where
218 sitesin 23 countries
Study dates
9 Sep 2024to 24 Apr 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

218 sites in 23 countries.

218 sites in 23 countries

Brazil36 sites

  • Fundacao Pio XII - Hospital de Cancer de Barretos

    Barretos, São Paulo, 14784-400

  • Cetus Oncologia S.A. Unidade Belo Horizonte

    Belo Horizonte, Minas Gerais, 30110-022

  • Nucleo de Ensino Pesquisa e Inovacao Mario Penna

    Belo Horizonte, Minas Gerais, 30380-472

  • Hospital Tacchini

    Bento Gonçalves, Rio Grande do Sul, 95700-000

  • OC Oncoclinicas Oncovida

    Brasília, Destrito Federal, 70390-150

  • Centro de Pesquisas Clinicas em Oncologia (CPCO)/HECI

    Cachoeiro de Itapemirim, Espírito Santo, 29308-014

  • Centro de Pesquisa Sao Lucas

    Campinas, São Paulo, 13060-904

  • Hospital Nossa Senhora das Gracas

    Canoas, 92030-000

  • Centro de Oncologia de Santa Catarina Ltda / Supera Oncologia

    Chapecó, Santa Catarina, 89801-355

  • Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner

    Curitiba, Paraná, 81520-060

  • CIONC - Centro Integrado de Oncologia de Curitiba

    Curitiba, 81480-580

  • CEPEN Centro de Pesquisa e Ensino em Saude de Santa Catarina

    Florianópolis, Santa Catarina, 88020-210

  • CRIO - Centro Regional Integrado de Oncologia

    Fortaleza, Ceará, 60335-480

  • Oncosite Centro De Pesquisa Clinica Em Oncologia

    Ijuí, Rio Grande do Sul, 98700-000

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

    Ipatinga, Minas Gerais, 35162-189

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

    Joinville, Santa Catarina, 89201-260

  • Hospital Bruno Born

    Lajeado, Rio Grande do Sul, 95900-000

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

    Londrina, Paraná, 86015-520

  • Centro Oncologico Mogi das Cruzes

    Mogi das Cruzes, São Paulo, 08730-500

  • Liga Contra o Cancer

    Natal, Rio Grande do Norte, 59062-000

  • Hospital da Cidade de Passo Fundo - HCPF

    Passo Fundo, Rio Grande do Sul, 99010-260

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

    Pelotas, Rio Grande do Sul, 96020-080

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

    Porto Alegre, Rio Grande do Sul, 90610-000

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

    Porto Alegre, 91350-200

  • 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

  • Instituto Ribeiraopretano de Combate ao Cancer (IRPCc) - IRPCC

    Ribeirão Preto, São Paulo, 14015-130

  • Instituto Nacional de Cancer (INCA)

    Rio de Janeiro, 20231-050

  • Instituto Americas - Ensino, Pesquisa e Inovacao

    Rio de Janeiro, 22775-001

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

    Rio de Janeiro - RJ, 22250-905

  • Hospital Santa Izabel, Santa Casa de Misericordia da Bahia

    Salvador, Estado de Bahia, 40050-410

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

    Salvador, 41253- 190

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

    Santo André, São Paulo, 09060-0650

  • 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

  • Hospital Alemao Oswaldo Cruz (HAOC)

    São Paulo, 01327-001

  • Instituto Brasileiro de Controle do Cancer - IBCC Oncologia

    São Paulo, 04014-002

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

    Vitória, Espírito Santo, 29043-260

Other trials in Brazil

Japan21 sites

  • Hyogo Prefectural Amagasaki General Medical Center

    Amagasaki, Hyōgo, 660-8550

  • Asahikawa Medical University Hospital

    Asahikawa, Hokkaido, Japan, 078-8510

  • Kyushu University Hospital

    Fukuoka, Fukuoka, 812-8582

  • Chugoku Central Hospital

    Fukuyama, Hiroshima, 720-0001

  • Funabashi Municipal Medical Center

    Funabashi-shi, Chiba, 273-8588

  • Seirei Hamamatsu General Hospital

    Hamamatsu, Shizuoka, 430-8558

  • Hamamatsu Medical Center

    Hamamatsu, Shizuoka, Japan, 432-8580

  • Hiroshima Prefectural Hospital

    Hiroshima, Hiroshima, 734-8530

  • Aso Iizuka Hospital

    Iizuka-shi, Fukuoka, 820-8505

  • Kawaguchi Municipal Medical Center

    Kawaguchi-shi, Saitama, 333-0833

  • Nippon Medical School Musashikosugi Hospital

    Kawasaki-shi, Kanagawa, 211-8533

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

    Kumamoto, Kumamoto, 861-4193

  • Japanese Red Cross Maebashi Hospital

    Maebashi, Gunma, 371-0811

  • Shinshu University Hospital

    Matsumoto, Nagano, 390-8621

  • Miyazaki Prefectural Miyazaki Hospital

    Miyazaki, Miyazaki, 880-8510

  • Japan Community Healthcare Organization Chukyo Hospital

    Nagoya, Aichi-ken, 457-8510

  • Ome Medical Center

    Ome-shi, Tokyo, 198-0042

  • Osaki Citizen Hospital

    Ōsaki, Miyagi, 989-6183

  • NHO Kinki Chuo Chest Medical Center

    Sakai, Osaka Japan, 591-8555

  • Yokohama City University Hospital

    Yokohama, Kanagawa, 236-0004

  • Yokosuka Kyosai Hospital

    Yokosuka, Kanagawa, 238-8558

Other trials in Japan

Turkey (Türkiye)21 sites

  • Medical Park Seyhan Hospital

    Adana, 01230

  • Adana City Training and Research Hospital

    Adana, 4522

  • Ankara Universitesi Tip Fakultesi Cebeci Hastanesi

    Ankara, 06100

  • Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

    Ankara, 06200

  • Memorial Ankara Hospital

    Ankara, 06520

  • Liv Hospital Ankara

    Ankara, 06680

  • Ankara Bilkent City Hospital

    Ankara, 06800

  • Ondokuz Mayis University Health Practice and Research Hospital

    Atakum, Samsun, 55280

  • Uludag University Medical Faculty

    Bursa, 16059

  • Medical Point Gaziantep Hospital

    Gaziantep, 27584

  • Trakya University Faculty of Medicine

    İskender, Edirne, 22130

  • Bezmialem Foundation University Medical Faculty

    Istanbul, 34093

  • Yeditepe University Kosuyolu Hospital

    Istanbul, 34718

  • Istanbul Medeniyet University Medical Faculty

    Istanbul, 34720

  • Gulhane Training and Research Hospital

    Keçiören, Ankara, 06010

  • Kocaeli Universitesi Tip Fakultesi

    Kocaeli, 41380

  • Necmettin Erbakan University Meram Medical Faculty

    Konya, 42080

  • Sakarya Universitesi Tip Fakultesi

    Sakarya, 54290

  • Adana Ortadogu Hospital

    Seyhan, Adana, 67055

  • Namik Kemal Universitesi Hastanesi

    Tekirdağ, 59100

  • Gazi University Faculty of Medicine

    Yenimahalle, Ankara, 06560

Other trials in Turkey (Türkiye)

United States15 sites

  • Accellacare of McFarland

    Ames, Iowa, 50010

  • Precision NextGen Oncology and Research Center

    Beverly Hills, California, 90212

  • Gabrail Cancer Center Research

    Canton, Ohio, 44718

  • TOI Clinical Research

    Cerritos, California, 90703

  • Detroit Clinical Research Center, PC

    Farmington Hills, Michigan, 48334

  • Millennium Oncology - Hollywood

    Hollywood, Florida, 33024

  • Millennium Research and Clinical Development, LLC

    Houston, Texas, 77090

  • Cancer and Blood Specialty Clinic (CBSC)

    Los Alamitos, California, 90720-3309

  • Valkyrie Clinical Trials

    Los Angeles, California, 90067

  • Accellacare Duly

    Plainfield, Illinois, 60585

  • Texas Oncology, P.A

    San Antonio, Texas, 78217

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

    Shirley, New York, 11967

  • BRCR Medical Center Inc.

    Tamarac, Florida, 33321

  • PIH Health Hospital

    Whittier, California, 90602

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

    Wytheville, Virginia, 24382

Other trials in United States

Spain14 sites

  • Hospital General Universitario de Elche

    Alicante, 03203

  • UOMI Cancer Center-Clinica Tres Torres

    Barcelona, 08017

  • Hospital Quironsalud Barcelona

    Barcelona, 08023

  • Complejo Hospitalario de Jaen (University Hospital Ciudad De Jaen)

    Jaén, 23007

  • Hospital Universitario San Francisco de Asis

    Madrid, 28002

  • Hospital Unifersitario Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Universitario Fundacion Alcorcon

    Madrid, 28922

  • Hospital Quironsalud Malaga

    Málaga, 29004

  • Hospital De Mataro

    Mataró, 08304

  • Hospital Universitario Central de Asturias

    Oviedo, 33011

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Universitario Nuestra Senora De Valme

    Seville, 41014

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

    Valencia, 46026

  • Hospital Quironsalud Valencia

    Valencia, Â 46010

Other trials in Spain

Philippines11 sites

  • Riverside Medical Center Inc

    Bacolod City, Negros Occidental, 6100

  • Cebu Doctors University Hospital

    Cebu City, Cebu, 6000

  • Chong Hua Hospital

    Cebu City, Cebu, 6000

  • Perpetual Succour Hospital

    Cebu City, Central Visayas, 6000

  • Davao Doctors Hospital

    Davao City, Davao Del Sur, 8000

  • West Visayas State University Medical Center

    Iloilo City, Iloilo, 5000

  • St. Paul's Hospital of Iloilo, Inc.

    Iloilo City, Western Visayas, 5000

  • Philippine General Hospital

    Manila, 1000

  • Asian Hospital And Medical Center

    Muntinlupa, National Capital Region, 1780

  • Veterans Memorial Medical Center

    Quezon City, National Capital Region, 1110

  • St. Lukes Medical Center

    Quezon City, NCR, 1102

Other trials in Philippines

Taiwan11 sites

  • Dalin Tzu chi General Hospital - Buddhist Tzu chi Medical Foundation

    Chiayi City, 62247

  • National Taiwan University Hospital Yun-Lin Branch

    Douliu, 640

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756

  • Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung County, 83301

  • Tri-Service General Hospital

    Neihu, Taipei, 114202

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

    New Taipei City, 235

  • Chung Shan Medical University Hospital

    Taichung, 402

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Cheng Kung University Hospital

    Tainan, 70403

  • National Taiwan University Hospital (NTUH)

    Taipei, Zhongzheng Dist, 10050

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

South Korea9 sites

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong, 28644

  • Jeonbuk National University Hospital

    Jeonju, Jeollabuk-do, 54907

  • Kyung Hee University Hospital

    Seoul, 02447

  • Korea University Anam Hospital

    Seoul, 02841

  • Kangbuk Samsung Hospital

    Seoul, 03181

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

    Seoul, 06591

  • Korea University Guro Hospital

    Seoul, 08308

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

    Suwon, Gyeonggi-do, 16247

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 16499

Other trials in South Korea

France8 sites

  • Centre Hospitalier Universitaire de Bordeaux - Hopital Saint - Andre

    Bordeaux, 33075

  • Centre Hospitalier Universitaire (CHU) De Limoges Hopital Dupuytren

    Limoges, 87000

  • Hopital Europeen Marseille

    Marseille, 13003

  • Clinique Clementville-Gcs Centre De Cancerologie Du Grand Montpellier

    Montpellier, 34070

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

    Nîmes, 30029

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

    Toulon, 83000

  • Clinique Teissier

    Valenciennes, 59300

  • Hopital Robert Schuman

    Vantoux, 57070

Other trials in France

Italy8 sites

  • Azienda Ospedaliero - Universitaria di Ferrara

    Cona, 44124

  • Azienda Socio Sanitaria Territoriale di Cremona

    Cremona, 26100

  • Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico Di Milano

    Milan, 20122

  • UOC Oncoematologia AOU Luigi Vanvitelli

    Naples, 80131

  • ASL Napoli 1 Centro-Ospedale del Mare

    Naples, 80147

  • AUSL Della Romagna - Ospedale S.Maria delle Croci

    Ravenna, 48121

  • S.C. Oncologia Medica-Presidio Ospedaliero Sondrio

    Sondrio, 23100

  • Azienda Ospedaliera Santa Maria Terni

    Terni, 05100

Other trials in Italy

Thailand8 sites

  • Faculty of Medicine Vajira Hospital, Navamindradhiraj University

    Bangkok, 10300

  • King Chulalongkorn Memorial Hospital, Chulalongkom University

    Bangkok, 10330

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

    Bangkoknoi, Bangkok, 10700

  • Prince Of Songkla Hospital, Prince Of Songkhla University

    Hat Yai, Changwat Songkhla, 90110

  • Chiangrai Prachanukroh Hospital

    Muang, Changwat Chiang Rai, 57000

  • Naresuan University Hospital

    Muang, Changwat Phitsanulok, 65000

  • Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University

    Muang, Chiang Mai, 52000

  • Chulabhorn Hospital

    Talat Bang Khen, Lak Si, 10210

Other trials in Thailand

Chile7 sites

  • CDIEM - Centro de Investigacion y Especialidades Medicas

    Providencia, Santiago Metropolitan, 7500859

  • Centro de Oncologa de Precisin

    Region Metropolitana, Santiago Metropolitan, 7560908

  • Clinica Santa Maria

    Santiago, Santiago Metropolitan, 7520349

  • K2 Oncology

    Santiago, 2209

  • Icegclinic Research and Care

    Santiago, 8240000

  • Oncocentro APYS

    Viña del Mar, Valparaiso, 2520598

  • Centro de Investigaciones Clinicas Vina del Mar Ltda.

    Viña del Mar, Valparaiso, 2540364

Other trials in Chile

Peru7 sites

  • Centro Medico Monte Carmelo

    Arequipa, 04001

  • Clinic Vallesur Arequipa

    Arequipa, 04001

  • Hospital IV - Alberto Sabogal Sologuren Red Asistencial Sabogal

    Bellavista, Provincia Constitucional del Callao, 07001

  • Hospital III Goyeneche

    Cercado, Arequipa, 04001

  • Hospital de Apoyo Maria Auxiliadora

    Lima, 15801

  • Instituto Nacional De Enfermedades Neoplasicas

    Surquillo, Lima, Peru, 15038

  • Clnica San Antonio

    Trujillo, 13008

Other trials in Peru

Poland7 sites

  • Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

  • Instytut MSF Sp. z o.o.

    Lodz, 90-302

  • Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

    Lublin, Lublin Voivodeship, 20-954

  • NZOZ Neuromed M. i M. Nastaj Sp.P

    Lublin, 20-064

  • Warminsko Mazurskie Centrum Chorob Pluc w Olsztynie

    Olsztyn, Warmian-Masurian Voivodeship, 10-357

  • Med-Polonia Sp. z o.o.

    Poznan, 60-693

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

    Słupsk, 76-200

Other trials in Poland

Argentina6 sites

  • IONC - Instituto Oncologico de Cordoba

    Córdoba, 5001

  • Instituto de Investigaciones Clinicas Mar del Plata

    Mar del Plata, Buenos Aires, B7600

  • Centro de Investigacion Pergamino SA

    Pergamino, Buenos Aires, B2700CPM

  • Sanatorio Britanico De Rosario

    Rosario, Santa Fe Province, S2000CVB

  • Hospital Provincial del Centenario

    Rosario, Santa Fe Province, S2002KDT

  • Fundacion ARS Medica

    San Salvador de Jujuy, Jujuy Province, 4600

Other trials in Argentina

Georgia6 sites

  • High Technology Hospital Medcenter LTD

    Batumi, 6000

  • Israel-Georgian Medical Research Clinic Healthycore

    Tbilisi, 0112

  • LLC Todua Clinic

    Tbilisi, 0112

  • TIM -Tbilisi Institute of Medicine

    Tbilisi, 0160

  • New Hospitals

    Tbilisi, 0162

  • Medulla - Clinics And Medical Centers

    Tbilisi, 0168

Other trials in Georgia

Malaysia5 sites

  • Hospital Sultanah Bahiyah

    Alor Star, Kedah, 05460

  • Hospital Canselor Tuanku Muhriz UKM

    Cheras, Kuala Lumpur, 56000

  • Raja Perempuan Zainab II Hospital

    Kota Bharu, Kelantan, 15586

  • University of Malaya Medical Centre

    Kuala Lumpur, 59100

  • Sarawak General Hospital

    Kuching, Sarawak, 93586

Other trials in Malaysia

South Africa5 sites

  • Dr W M Szpak Inc - Rainbow Oncology

    Athlone Park, KwaZulu-Natal, 4126

  • GVI Oncology, Langenhoven Drive Oncology Centre

    Port Elizabeth, Eastern Cape, 6045

  • University of Pretoria and Steve Biko Academic Hospital Complex

    Pretoria, Gauteng, 0002

  • Life Wilgers Hospital Wilgers Oncology Centre

    Pretoria, Gauteng, 0040

  • Abraham Oncology

    Richards Bay, KwaZulu-Natal, 3900

Other trials in South Africa

Germany4 sites

  • Evang. Kliniken Essen Mitte GmbH

    Essen, 45136

  • Studienzentrum Aschaffenburg

    Hösbach, 63768

  • Haematologie, Onkologie und Palliativmedizin, Tagesklinik Landshut

    Landshut, 84036

  • FEK - Friedrich-Ebert-Krankenhaus Neumuenster GmbH

    Neumünster, 24534

Other trials in Germany

Bulgaria3 sites

  • MHAT Dobrich AD

    Dobrich, 5500

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

    Sofia, Sofia-Grad, 1431

  • University Multiprofile Hospital for Active Treatment Sofiamed

    Sofia, 1797

Other trials in Bulgaria

Serbia3 sites

  • Clincial Centre of Serbia

    Belgrade, 11000

  • Institute for Pulmonary Diseases of Vojvodina

    Kamenitz, 21204

  • University Clinical Centre of Kragujevac

    Kragujevac, 34000

Other trials in Serbia

Austria2 sites

  • Klinikum Klagenfurt am Woerthersee

    Klagenfurt, 9020

  • Ordensklinikum Linz GmbH Elisabethinen

    Linz, 4020

Other trials in Austria

United Kingdom1 site

  • Nottingham University Hospitals NHS Trust - Nottingham City Hospital

    Nottingham, Nottinghamshire, NG5 1PB

Other trials in United Kingdom

About this study

Official title: A Randomized, Double-Blind Study to Compare Efficacy, Pharmacokinetics, Safety, and Immunogenicity Between ABP 234 and Keytruda® (Pembrolizumab) in Subjects With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer

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

Being tested
ABP 234, Pembrolizumab (US), Pembrolizumab (EU)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABP 234Drug

    Intravenous administration

  • Pembrolizumab (US)Drug

    Also called Keytruda®

    Intravenous administration

  • Pembrolizumab (EU)Drug

    Also called Keytruda®

    Intravenous administration

Study groups in NCT06311721
Study groupRoleWhat they receive
ABP 234ExperimentalPart 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.
Receives: Drug: ABP 234
Pembrolizumab (US)ExperimentalPart 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.
Receives: Drug: Pembrolizumab (US)
Pembrolizumab (EU)ExperimentalPart 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.
Receives: Drug: Pembrolizumab (EU)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 21 days

  2. AUC21d of pembrolizumab (US)

    Measured: 21 days

  3. AUC21d of pembrolizumab (EU)

    Measured: 21 days

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

    Measured: Week 16 through Week 19

  5. AUCtau_ss of pembrolizumab (US)

    Measured: Week 16 through Week 19

  6. AUCtau_ss of pembrolizumab (EU)

    Measured: Week 16 through Week 19

Secondary outcomes (28)

  1. Objective response (OR)

    OR defined as an overall response of confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

    Measured: Week 49

  2. OR

    Measured: Week 13

  3. OR

    Measured: Week 31

  4. Duration of response (DOR)

    Measured: Up to 2.5 years

  5. Progression-free survival (PFS)

    Measured: Up to 2.5 years

  6. Overall survival (OS)

    Measured: Up to 2.5 years

  7. Maximum observed serum concentration following the first dose (Cmax_dose1) of ABP 234

    Measured: Day 1 up to Week 107

  8. Cmax_dose1 of pembrolizumab (US)

    Measured: Day 1 up to Week 107

  9. Cmax_dose1 of pembrolizumab (EU)

    Measured: Day 1 up to Week 107

  10. Time to maximum concentration following the first dose (tmax_dose1) of ABP 234

    Measured: Day 1 up to Week 107

  11. Tmax_dose1 of pembrolizumab (US)

    Measured: Day 1 up to Week 107

  12. Tmax_dose1 of pembrolizumab (EU)

    Measured: Day 1 up to Week 107

  13. Maximum observed serum concentration (Cmax) at steady state (Cmax_ss) of ABP 234

    Measured: Week 16 through Week 19

  14. Cmax_ss of pembrolizumab (US)

    Measured: Week 16 through Week 19

  15. Cmax_ss of of pembrolizumab (EU)

    Measured: Week 16 through Week 19

  16. Time to maximum concentration at steady state (tmax_ss) of ABP 234

    Measured: Week 16 through Week 19

  17. Tmax_ss of pembrolizumab (US)

    Measured: Week 16 through Week 19

  18. Tmax_ss of pembrolizumab (EU)

    Measured: Week 16 through Week 19

  19. Trough serum concentrations at pre-dose of week 4 (Ctrough_w4) of ABP 234

    Measured: Week 4

  20. Ctrough_w4 of pembrolizumab (US)

    Measured: Week 4

  21. Ctrough_w4 of pembrolizumab (EU)

    Measured: Week 4

  22. Trough serum concentrations at steady state (Ctrough_ss) at pre-dose of ABP 234

    Measured: Week 16 through Week 19

  23. Ctrough_ss at pre-dose of pembrolizumab (US)

    Measured: Week 16 through Week 19

  24. Ctrough_ss at pre-dose of pembrolizumab (EU)

    Measured: Week 16 through Week 19

  25. Number of participants who experience a Treatment-emergent adverse event

    Measured: Up to 2.5 years

  26. Number of participants who experience a Treatment-emergent serious adverse event

    Measured: Up to 2.5 years

  27. Number of participants who experience a Treatment-emergent adverse event of interest

    Measured: Up to 2.5 years

  28. Number of participants who experience anti-drug antibodies (ADA)

    Measured: Up to 2.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2024
  2. Study start9 Sep 2024
  3. Primary completion10 Jan 2028 (estimated)
  4. Study completion24 Apr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
315 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06311721
Sponsor's protocol ID
20210033
Other IDs
2023-508336-57, 2024-514304-14-00, 2023
Status last verified
Mar 2026
First submitted
8 Mar 2024
Last updated
6 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ABP 234, Pembrolizumab (US) and Pembrolizumab (EU) in people with Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer, run by Amgen at 218 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 218 sites in Brazil, Japan, Turkey (Türkiye), United States, Spain and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under the serum concentration-time curve (AUC) from time 0 to 21 days (AUC21d) of ABP 234 (time frame: 21 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06311721.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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