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

NCT ID: NCT06311721

Last Updated: 2026-01-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 315 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-09
• Study Completion Date: 2028-05-29

Brief Summary

The primary objective of this study is to compare the efficacy of ABP 234 with the pembrolizumab reference product (Keytruda®).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ABP 234

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.

Group Type: EXPERIMENTAL

ABP 234

Intervention Type: DRUG

Intravenous administration

Pembrolizumab (US)

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.

Group Type: EXPERIMENTAL

Pembrolizumab (US)

Intervention Type: DRUG

Intravenous administration

Pembrolizumab (EU)

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.

Group Type: EXPERIMENTAL

Pembrolizumab (EU)

Intervention Type: DRUG

Intravenous administration

Interventions

ABP 234

Intravenous administration

Intervention Type: DRUG

Pembrolizumab (US)

Intravenous administration

Intervention Type: DRUG

Pembrolizumab (EU)

Intravenous administration

Intervention Type: DRUG

Other Intervention Names

Keytruda®; Keytruda®

Eligibility Criteria

Inclusion Criteria

1. At least 18 years of age.

2. Histologically or cytologically confirmed stage IV non-squamous Non-Small Cell Lung Cancer (NSCLC).

3. Participant has no prior systemic treatment for advanced disease.

4. Measurable disease according to RECIST v1.1.

5. Tumor tissue from the resected site of disease must be available for biomarker analyses in order to be randomized.

6. Eastern Cooperative Oncology Group performance status score 0 or 1.

7. 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

8. Have a life expectancy of at least 3 months.

Exclusion Criteria

1. Small cell lung cancer (SCLC) or mixed SCLC/NSCLC histology or squamous cell carcinoma.

2. Participant has active central nervous system metastases not previously treated.

3. Participant has active or known immune-mediated disorders.

4. Participant has received prior systemic cytotoxic chemotherapy, immunotherapy (including PD-1/PD-L1), anti-neoplastic biological therapy, or targeted therapy for advanced/metastatic disease.

5. Known hypersensitivity to monoclonal antibodies or to any of the excipients of the study drug, or to any component of cisplatin, carboplatin, or pemetrexed.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Locations

Precision NextGen Oncology and Research Center

Beverly Hills, California, United States

TOI Clinical Research

Cerritos, California, United States

Cancer and Blood Specialty Clinic (CBSC)

Los Alamitos, California, United States

Valkyrie Clinical Trials

Los Angeles, California, United States

PIH Health Hospital

Whittier, California, United States

Millennium Oncology - Hollywood

Hollywood, Florida, United States

BRCR Medical Center Inc.

Tamarac, Florida, United States

Accellacare Duly

Plainfield, Illinois, United States

Accellacare of McFarland

Ames, Iowa, United States

Detroit Clinical Research Center, PC

Farmington Hills, Michigan, United States

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

Shirley, New York, United States

Gabrail Cancer Center Research

Canton, Ohio, United States

Millennium Research and Clinical Development, LLC

Houston, Texas, United States

Texas Oncology, P.A

San Antonio, Texas, United States

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

Wytheville, Virginia, United States

Instituto de Investigaciones Clinicas Mar del Plata

Mar del Plata, Buenos Aires, Argentina

Centro de Investigacion Pergamino SA

Pergamino, Buenos Aires, Argentina

Fundacion ARS Medica

San Salvador de Jujuy, Jujuy Province, Argentina

Sanatorio Britanico De Rosario

Rosario, Santa Fe Province, Argentina

Hospital Provincial del Centenario

Rosario, Santa Fe Province, Argentina

IONC - Instituto Oncologico de Cordoba

Córdoba, , Argentina

Klinikum Klagenfurt am Woerthersee

Klagenfurt, , Austria

Ordensklinikum Linz GmbH Elisabethinen

Linz, , Austria

CRIO - Centro Regional Integrado de Oncologia

Fortaleza, Ceará, Brazil

OC Oncoclinicas Oncovida

Brasília, Destrito Federal, Brazil

Centro de Pesquisas Clinicas em Oncologia (CPCO)/HECI

Cachoeiro de Itapemirim, Espírito Santo, Brazil

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

Vitória, Espírito Santo, Brazil

Hospital Santa Izabel, Santa Casa de Misericordia da Bahia

Salvador, Estado de Bahia, Brazil

Cetus Oncologia S.A. Unidade Belo Horizonte

Belo Horizonte, Minas Gerais, Brazil

Nucleo de Ensino Pesquisa e Inovacao Mario Penna

Belo Horizonte, Minas Gerais, Brazil

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

Ipatinga, Minas Gerais, Brazil

Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner

Curitiba, Paraná, Brazil

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

Londrina, Paraná, Brazil

Liga Contra o Cancer

Natal, Rio Grande do Norte, Brazil

Hospital Tacchini

Bento Gonçalves, Rio Grande do Sul, Brazil

Oncosite Centro De Pesquisa Clinica Em Oncologia

Ijuí, Rio Grande do Sul, Brazil

Hospital Bruno Born

Lajeado, Rio Grande do Sul, Brazil

Hospital da Cidade de Passo Fundo - HCPF

Passo Fundo, Rio Grande do Sul, Brazil

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

Pelotas, Rio Grande do Sul, Brazil

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

Porto Alegre, Rio Grande do Sul, Brazil

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, Brazil

Centro de Oncologia de Santa Catarina Ltda / Supera Oncologia

Chapecó, Santa Catarina, Brazil

CEPEN Centro de Pesquisa e Ensino em Saude de Santa Catarina

Florianópolis, Santa Catarina, Brazil

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

Joinville, Santa Catarina, Brazil

Fundacao Pio XII - Hospital de Cancer de Barretos

Barretos, São Paulo, Brazil

Centro de Pesquisa Sao Lucas

Campinas, São Paulo, Brazil

Centro Oncologico Mogi das Cruzes

Mogi das Cruzes, São Paulo, Brazil

Instituto Ribeiraopretano de Combate ao Cancer (IRPCc) - IRPCC

Ribeirão Preto, São Paulo, Brazil

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

Santo André, São Paulo, Brazil

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, Brazil

Hospital Nossa Senhora das Gracas

Canoas, , Brazil

CIONC - Centro Integrado de Oncologia de Curitiba

Curitiba, , Brazil

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

Porto Alegre, , Brazil

Instituto Nacional de Cancer (INCA)

Rio de Janeiro, , Brazil

Instituto Americas - Ensino, Pesquisa e Inovacao

Rio de Janeiro, , Brazil

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

Rio de Janeiro - RJ, , Brazil

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

Salvador, , Brazil

Hospital Alemao Oswaldo Cruz (HAOC)

São Paulo, , Brazil

Instituto Brasileiro de Controle do Cancer - IBCC Oncologia

São Paulo, , Brazil

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

Sofia, Sofia-Grad, Bulgaria

MHAT Dobrich AD

Dobrich, , Bulgaria

University Multiprofile Hospital for Active Treatment Sofiamed

Sofia, , Bulgaria

Oncocentro

Viña del Mar, Región de Valparaíso, Chile

Centro de Investigaciones Clinicas Vina del Mar Ltda.

Viña del Mar, Región de Valparaíso, Chile

CDIEM - Centro de Investigacion y Especialidades Medicas

Providencia, Santiago Metropolitan, Chile

Centro de Oncologa de Precisin

Region Metropolitana, Santiago Metropolitan, Chile

Clinica Santa Maria

Santiago, Santiago Metropolitan, Chile

K2 Oncology

Santiago, , Chile

Icegclinic Research and Care

Santiago, , Chile

Centre Hospitalier Universitaire de Bordeaux - Hopital Saint - Andre

Bordeaux, , France

Centre Hospitalier Universitaire (CHU) De Limoges Hopital Dupuytren

Limoges, , France

Hopital Europeen Marseille

Marseille, , France

Clinique Clementville-Gcs Centre De Cancerologie Du Grand Montpellier

Montpellier, , France

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

Nîmes, , France

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

Toulon, , France

Clinique Teissier

Valenciennes, , France

Hopital Robert Schuman

Vantoux, , France

High Technology Hospital Medcenter LTD

Batumi, , Georgia

Israel-Georgian Medical Research Clinic Healthycore

Tbilisi, , Georgia

LLC Todua Clinic

Tbilisi, , Georgia

TIM -Tbilisi Institute of Medicine

Tbilisi, , Georgia

New Hospitals

Tbilisi, , Georgia

Medulla - Clinics And Medical Centers

Tbilisi, , Georgia

Evang. Kliniken Essen Mitte GmbH

Essen, , Germany

Studienzentrum Aschaffenburg

Hösbach, , Germany

Haematologie, Onkologie und Palliativmedizin, Tagesklinik Landshut

Landshut, , Germany

FEK - Friedrich-Ebert-Krankenhaus Neumuenster GmbH

Neumünster, , Germany

Azienda Ospedaliero - Universitaria di Ferrara

Cona, , Italy

Azienda Socio Sanitaria Territoriale di Cremona

Cremona, , Italy

Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico Di Milano

Milan, , Italy

UOC Oncoematologia AOU Luigi Vanvitelli

Naples, , Italy

ASL Napoli 1 Centro-Ospedale del Mare

Napoli, , Italy

AUSL Della Romagna - Ospedale S.Maria delle Croci

Ravenna, , Italy

S.C. Oncologia Medica-Presidio Ospedaliero Sondrio

Sondrio, , Italy

Azienda Ospedaliera Santa Maria Terni

Terni, , Italy

Japan Community Healthcare Organization Chukyo Hospital

Nagoya, Aichi-ken, Japan

Funabashi Municipal Medical Center

Funabashi-shi, Chiba, Japan

Kyushu University Hospital

Fukuoka, Fukuoka, Japan

Aso Iizuka Hospital

Iizuka-shi, Fukuoka, Japan

Japanese Red Cross Maebashi Hospital

Maebashi, Gunma, Japan

Chugoku Central Hospital

Fukuyama, Hiroshima, Japan

Hiroshima Prefectural Hospital

Hiroshima, Hiroshima, Japan

Asahikawa Medical University Hospital

Asahikawa, Hokkaido, Japan, Japan

Hyogo Prefectural Amagasaki General Medical Center

Amagasaki, Hyōgo, Japan

Nippon Medical School Musashikosugi Hospital

Kawasaki-shi, Kanagawa, Japan

Yokohama City University Hospital

Yokohama, Kanagawa, Japan

Yokosuka Kyosai Hospital

Yokosuka, Kanagawa, Japan

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

Kumamoto, Kumamoto, Japan

Osaki Citizen Hospital

Ōsaki, Miyagi, Japan

Miyazaki Prefectural Miyazaki Hospital

Miyazaki, Miyazaki, Japan

Shinshu University Hospital

Matsumoto, Nagano, Japan

NHO Kinki Chuo Chest Medical Center

Sakai, Osaka Japan, Japan

Kawaguchi Municipal Medical Center

Kawaguchi-shi, Saitama, Japan

Seirei Hamamatsu General Hospital

Hamamatsu, Shizuoka, Japan

Hamamatsu Medical Center

Hamamatsu, Shizuoka, Japan, Japan

Ome Medical Center

Ome-shi, Tokyo, Japan

Hospital Sultanah Bahiyah

Alor Star, Kedah, Malaysia

Raja Perempuan Zainab II Hospital

Kota Bharu, Kelantan, Malaysia

Hospital Canselor Tuanku Muhriz UKM

Cheras, Kuala Lumpur, Malaysia

Sarawak General Hospital

Kuching, Sarawak, Malaysia

University of Malaya Medical Centre

Kuala Lumpur, , Malaysia

Hospital III Goyeneche

Cercado, Arequipa, Peru

Instituto Nacional De Enfermedades Neoplasicas

Surquillo, Lima, Peru, Peru

Hospital IV - Alberto Sabogal Sologuren Red Asistencial Sabogal

Bellavista, Provincia Constitucional del Callao, Peru

Centro Medico Monte Carmelo

Arequipa, , Peru

Clinic Vallesur Arequipa

Arequipa, , Peru

Hospital de Apoyo Maria Auxiliadora

Lima, , Peru

Clnica San Antonio

Trujillo, , Peru

Cebu Doctors University Hospital

Cebu City, Cebu, Philippines

Chong Hua Hospital

Cebu City, Cebu, Philippines

Perpetual Succour Hospital

Cebu City, Central Visayas, Philippines

Davao Doctors Hospital

Davao City, Davao Del Sur, Philippines

West Visayas State University Medical Center

Iloilo City, Iloilo, Philippines

Asian Hospital And Medical Center

Muntinlupa, National Capital Region, Philippines

Veterans Memorial Medical Center

Quezon City, National Capital Region, Philippines

St. Lukes Medical Center

Quezon City, NCR, Philippines

Riverside Medical Center Inc

Bacolod City, Negros Occidental, Philippines

St. Paul's Hospital of Iloilo, Inc.

Iloilo City, Western Visayas, Philippines

Philippine General Hospital

Manila, , 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

Instytut MSF Sp. z o.o.

Lodz, , Poland

NZOZ Neuromed M. i M. Nastaj Sp.P

Lublin, , Poland

Med-Polonia Sp. z o.o.

Poznan, , Poland

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

Słupsk, , Poland

Clincial Centre of Serbia

Belgrade, , Serbia

Institute for Pulmonary Diseases of Vojvodina

Kamenitz, , Serbia

University Clinical Centre of Kragujevac

Kragujevac, , Serbia

GVI Oncology, Langenhoven Drive Oncology Centre

Port Elizabeth, Eastern Cape, South Africa

University of Pretoria and Steve Biko Academic Hospital Complex

Pretoria, Gauteng, South Africa

Life Wilgers Hospital Wilgers Oncology Centre

Pretoria, Gauteng, South Africa

Dr W M Szpak Inc - Rainbow Oncology

Athlone Park, KwaZulu-Natal, South Africa

Abraham Oncology

Richards Bay, KwaZulu-Natal, South Africa

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

Kyung Hee University Hospital

Seoul, , South Korea

Korea University Anam Hospital

Seoul, , South Korea

Kangbuk Samsung Hospital

Seoul, , South Korea

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

Seoul, , South Korea

Korea University Guro Hospital

Seoul, , South Korea

Hospital General Universitario de Elche

Alicante, , Spain

UOMI Cancer Center-Clinica Tres Torres

Barcelona, , Spain

Hospital Quironsalud Barcelona

Barcelona, , Spain

Complejo Hospitalario de Jaen (University Hospital Ciudad De Jaen)

Jaén, , Spain

Hospital Universitario San Francisco de Asis

Madrid, , Spain

Hospital Unifersitario Fundacion Jimenez Diaz

Madrid, , Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, , Spain

Hospital Universitario Fundacion Alcorcon

Madrid, , Spain

Hospital De Mataro

Mataró, , Spain

Hospital Quironsalud Malaga

Málaga, , Spain

Hospital Universitario Central de Asturias

Oviedo, , Spain

Hospital Universitario Virgen del Rocio

Seville, , Spain

Hospital Universitario Nuestra Senora De Valme

Seville, , Spain

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

Valencia, , Spain

Hospital Quironsalud Valencia

Valencia, , Spain

Tri-Service General Hospital

Neihu, Taipei, Taiwan

National Taiwan University Hospital (NTUH)

Taipei, Zhongzheng Dist, Taiwan

Dalin Tzu chi General Hospital - Buddhist Tzu chi Medical Foundation

Chiayi City, , Taiwan

National Taiwan University Hospital Yun-Lin Branch

Douliu, , Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital

Kaohsiung County, , Taiwan

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

New Taipei City, , Taiwan

Chung Shan Medical University Hospital

Taichung, , Taiwan

Taichung Veterans General Hospital

Taichung, , Taiwan

National Cheng Kung University Hospital

Tainan, , Taiwan

Taipei Veterans General Hospital

Taipei, , Taiwan

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

Bangkoknoi, Bangkok, Thailand

Chiangrai Prachanukroh Hospital

Muang, Changwat Chiang Rai, 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

Chulabhorn Hospital

Talat Bang Khen, Lak Si, Thailand

Faculty of Medicine Vajira Hospital, Navamindradhiraj University

Bangkok, , Thailand

King Chulalongkorn Memorial Hospital, Chulalongkom University

Bangkok, , Thailand

Adana Ortadogu Hospital

Seyhan, Adana, Turkey (Türkiye)

Gulhane Training and Research Hospital

Keçiören, Ankara, Turkey (Türkiye)

Gazi University Faculty of Medicine

Yenimahalle, Ankara, Turkey (Türkiye)

Trakya University Faculty of Medicine

İskender, Edirne, Turkey (Türkiye)

Ondokuz Mayis University Health Practice and Research Hospital

Atakum, Samsun, Turkey (Türkiye)

Medical Park Seyhan Hospital

Adana, , Turkey (Türkiye)

Adana City Training and Research Hospital

Adana, , 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)

Uludag University Medical Faculty

Bursa, , Turkey (Türkiye)

Medical Point Gaziantep Hospital

Gaziantep, , Turkey (Türkiye)

Bezmialem Foundation University Medical Faculty

Istanbul, , Turkey (Türkiye)

Yeditepe University Kosuyolu Hospital

Istanbul, , Turkey (Türkiye)

Istanbul Medeniyet University Medical Faculty

Istanbul, , Turkey (Türkiye)

Kocaeli Universitesi Tip Fakultesi

Kocaeli, , Turkey (Türkiye)

Necmettin Erbakan University Meram Medical Faculty

Konya, , Turkey (Türkiye)

Sakarya Universitesi Tip Fakultesi

Sakarya, , Turkey (Türkiye)

Namik Kemal Universitesi Hastanesi

Tekirdağ, , Turkey (Türkiye)

Nottingham University Hospitals NHS Trust - Nottingham City Hospital

Nottingham, Nottinghamshire, United Kingdom

Countries

United States; Argentina; Austria; Brazil; Bulgaria; Chile; France; Georgia; Germany; Italy; Japan; Malaysia; Peru; Philippines; Poland; Serbia; South Africa; South Korea; Spain; Taiwan; Thailand; Turkey (Türkiye); United Kingdom

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

2023-508336-57

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2024-514304-14-00

Identifier Type: OTHER

Identifier Source: secondary_id

20210033

Identifier Type: -

Identifier Source: org_study_id