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

Last updated: November 27, 2024
Sponsor: Amgen
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Pembrolizumab (EU)

Pembrolizumab (US)

ABP 234

Clinical Study ID

NCT06311721
20210033
2023-508336-57
2024-514304-14-00
  • Ages 18-99
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. At least 18 years of age.

  2. Histologically or cytologically confirmed stage IV non-squamous Non-Small Cell LungCancer (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 biomarkeranalyses 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-rosoncogene 1, receptor tyrosine kinase of the insulin receptor family (ROS-1) negative

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

Exclusion

Exclusion Criteria:

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

  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 foradvanced/metastatic disease.

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

Study Design

Total Participants: 927
Treatment Group(s): 3
Primary Treatment: Pembrolizumab (EU)
Phase: 3
Study Start date:
September 09, 2024
Estimated Completion Date:
October 22, 2027

Connect with a study center

  • Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada

    Caba, Buenos Aires 1425
    Argentina

    Site Not Available

  • Instituto de Oncologia de Rosario

    Rosario, Santa Fe S2000KZE
    Argentina

    Terminated

  • Sanatorio Parque S.A.-Consultorios Externos Asociados S.A.

    Rosario, Santa Fe S2000SDV
    Argentina

    Site Not Available

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

    Sofia, Sofiya-Grad 1431
    Bulgaria

    Active - Recruiting

  • University Multiprofile Hospital for Active Treatment Sofiamed

    Sofia, 1797
    Bulgaria

    Active - Recruiting

  • Centro de Investigaciones Clinicas Vina del Mar Ltda.

    Vina del Mar, Region De Valparaiso 2540364
    Chile

    Active - Recruiting

  • Cdiem

    Providencia, Region Metropolotana 7500859
    Chile

    Active - Recruiting

  • Centro de Oncologa de Precisin

    Region Metropolitana, Santiago 7560908
    Chile

    Active - Recruiting

  • Oncocentro

    Vina Del Mar, Valparaiso 2520598
    Chile

    Active - Recruiting

  • Dr. James Lind MD, Office of

    Cautin, 4810469
    Chile

    Site Not Available

  • Icegclinic Research and Care

    Santiago,
    Chile

    Active - Recruiting

  • K2 Oncology

    Santiago de Chile, 2330
    Chile

    Active - Recruiting

  • Clinique Belharra Ramsay Sante

    Bayonne, 64100
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Bordeaux - Hopital Saint - Andre

    Bordeaux, 33000
    France

    Active - Recruiting

  • High Technology Hospital Medcenter LTD

    Batumi, 6000
    Georgia

    Active - Recruiting

  • LLC Todua Clinic

    Tbilisi, 0112
    Georgia

    Active - Recruiting

  • Medulla - Clinics And Medical Centers

    Tbilisi, 0168
    Georgia

    Active - Recruiting

  • New Hospitals

    Tbilisi, 0162
    Georgia

    Active - Recruiting

  • TIM -Tbilisi Institute of Medicine

    Tbilisi, 0160
    Georgia

    Active - Recruiting

  • Studienzentrum Aschaffenburg

    Aschaffenburg, 63739
    Germany

    Active - Recruiting

  • Haematologie, Onkologie und Palliativmedizin, Tagesklinik Landshut

    Landshut, 84028
    Germany

    Active - Recruiting

  • Tolna Varmegyei Balassa Janos Korhaz

    Szekszard, Tolna 7100
    Hungary

    Site Not Available

  • Orszagos Onkologiai Intezet (National Institute of Oncology)

    Budapest, 1122
    Hungary

    Site Not Available

  • Matrahaza Univesrity and Teaching hospital

    Matrahaza, 3233
    Hungary

    Site Not Available

  • Fejer Megyei Szent Gyorgy Korhaz, I. Pulmonologiai Osztaly

    Szekesfehervar, 8000
    Hungary

    Site Not Available

  • Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointzet

    Szolnok, 5000
    Hungary

    Site Not Available

  • Szent Borbala Hospital Tatabanya

    Tatabanya, 2800
    Hungary

    Site Not Available

  • Torokbalint Tudogyogyintezet

    Torokbalint, 2045
    Hungary

    Site Not Available

  • KLE University - Jawaharlal Nehru Medical College (JNMC)

    Belgaum, Karnataka 590010
    India

    Site Not Available

  • Bhakti Vedanta Hospital and Research Institute

    Thane, Maharashtra 401107
    India

    Site Not Available

  • Azienda Ospedaliero Universitaria Ospedali Riuniti Universita politecnica delle Marche

    Ancona, 60100
    Italy

    Site Not Available

  • Azienda Policlinico Universitario

    Monserrato, 09042
    Italy

    Site Not Available

  • Irccs - Centro Di Riferimento Oncologico Della Basilicata (Crob)

    Rionero In Vulture, 85028
    Italy

    Site Not Available

  • ASSt Sette Laghi

    Varese, 21100
    Italy

    Site Not Available

  • Japan Community Healthcare Organization Chukyo Hospital

    Nagoya, Aichi 457-8510
    Japan

    Active - Recruiting

  • Funabashi Municipal Medical Center

    Funabashi-shi, Chiba 273-8588
    Japan

    Active - Recruiting

  • Kyushu University Hospital

    Fukuoka, Fukuoka-shi 812-8582
    Japan

    Active - Recruiting

  • Japanese Red Cross Maebashi Hospital

    Maebashi-shi, Gunma 371-0811
    Japan

    Active - Recruiting

  • Chugoku Central Hospital

    Fukuyama city, Hiroshima 720-0001
    Japan

    Active - Recruiting

  • Hiroshima Prefectural Hospital

    Hiroshima-city, Hiroshima 734-8530
    Japan

    Active - Recruiting

  • Asahikawa Medical University Hospital

    Asahikawa City,, Hokkaido, Japan 078-8510
    Japan

    Active - Recruiting

  • Asahikawa Medical University Hospital

    Asahikawa, Hokkaid¿ 078-8510
    Japan

    Site Not Available

  • Hyogo Prefectural Amagasaki General Medical Center

    Amagasaki, Hyogo 660-8550
    Japan

    Active - Recruiting

  • Yokohama City University Hospital

    Yokohama, Kanagawa 236-0004
    Japan

    Active - Recruiting

  • Yokosuka Kyosai Hospital

    Yokosuka, Kanagawa 238-8558
    Japan

    Active - Recruiting

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

    Kumamoto city, Kumamoto 861-4193
    Japan

    Active - Recruiting

  • Osaki Citizen Hospital

    Osaki, Miyagi 989-6183
    Japan

    Active - Recruiting

  • Miyazaki Prefectural Miyazaki Hospital

    Miyazaki-shi, Miyazaki 880-8510
    Japan

    Active - Recruiting

  • Shinshu University Hospital

    Matsumoto, Nagano 390-8621
    Japan

    Active - Recruiting

  • NHO Kinki Chuo Chest Medical Center

    Sakai-city,, Osaka Japan 591-8555
    Japan

    Active - Recruiting

  • Seirei Hamamatsu General Hospital

    Hamamatsu, Shizuoka 430-8558
    Japan

    Active - Recruiting

  • Hamamatsu Medical Center

    Hamamatsu City, Shizuoka 432-8580
    Japan

    Active - Recruiting

  • Ome Medical Center

    Ome-shi, Tokyo 198-0042
    Japan

    Active - Recruiting

  • Japanese Red Cross Medical Center

    Shibuya-Ku, Tokyo 150-8935
    Japan

    Site Not Available

  • Nippon Medical School Musashikosugi Hospital

    Kanagawa, 211-8533
    Japan

    Active - Recruiting

  • Kawaguchi Municipal Medical Center

    Saitama, 333-0833
    Japan

    Active - Recruiting

  • Chungbuk National University Hospital

    Cheongju-si, Chungcheongbuk-do 28644
    Korea, Republic of

    Active - Recruiting

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

    Suwon-si, Gyeonggi 16247
    Korea, Republic of

    Active - Recruiting

  • Jeonbuk National University Hospital

    Jeonju-si, Jeollabuk-do 54907
    Korea, Republic of

    Active - Recruiting

  • Kangbuk Samsung Hospital

    Seoul, 03181
    Korea, Republic of

    Active - Recruiting

  • Korea University Anam Hospital

    Seoul, 02841
    Korea, Republic of

    Active - Recruiting

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

    Seoul, 06591
    Korea, Republic of

    Active - Recruiting

  • Centra Medyczne Medyceusz Sp. z o. o.

    Lodz, ¿ódzkie 91-053
    Poland

    Terminated

  • Instytut MSF Sp. z o.o.

    Lodz, 90-302
    Poland

    Active - Recruiting

  • Institutul Oncologic Prof. Dr. Ion Chiricuta

    Cluj-Napoca, Cluj 400015
    Romania

    Site Not Available

  • Municipal Hospital Ploiesti

    Ploiesti, Prahova 100337
    Romania

    Site Not Available

  • Oncocenter Oncologie Clinica S.R.L

    Timisoara, Timis 300210
    Romania

    Terminated

  • Oncomed

    Timisoara, Timis 300239
    Romania

    Site Not Available

  • Institutul Regional De Oncologie Iasi

    Iasi, 700483
    Romania

    Site Not Available

  • Centrul De Oncologie Euroclinic

    Jud. Iasi, 700106
    Romania

    Site Not Available

  • Clincial Centre of Serbia

    Belgrade, 11000
    Serbia

    Active - Recruiting

  • Institute for Pulmonary Diseases of Vojvodina

    Sremska Kamenica, 21204
    Serbia

    Active - Recruiting

  • Hospital Universitario Fundacion Alcorcon

    Alcorcon, 28922
    Spain

    Active - Recruiting

  • Hospital Quironsalud Barcelona

    Barcelona, 08023
    Spain

    Active - Recruiting

  • UOMI Cancer Center-Clinica Tres Torres

    Barcelona, 08017
    Spain

    Active - Recruiting

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

    Jaen, 23007
    Spain

    Active - Recruiting

  • Hospital Clinico San Carlos

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital Quironsalud Malaga

    Malaga, 29004
    Spain

    Active - Recruiting

  • Hospital Universitario Central de Asturias

    Oviedo, 33011
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen del Rocio

    Seville, 41013
    Spain

    Active - Recruiting

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

    Valencia, 46026
    Spain

    Active - Recruiting

  • Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital

    Ankara, 06200
    Turkey

    Active - Recruiting

  • Gulhane Egitim ve Arastirma Hastanesi

    Ankara, 06010
    Turkey

    Active - Recruiting

  • Memorial Ankara Hospital

    Ankara, 06520
    Turkey

    Active - Recruiting

  • Uludag University Medical Faculty

    Bursa, 16059
    Turkey

    Active - Recruiting

  • Necmettin Erbakan University Meram Medical Faculty

    Konya, 42080
    Turkey

    Active - Recruiting

  • Sakarya Universitesi Tip Fakultesi

    Sakarya, 54050
    Turkey

    Active - Recruiting

  • Namik Kemal Universitesi Hastanesi

    Tekirdag, 59100
    Turkey

    Active - Recruiting

  • University of Leicester School of Medicine, Leicester Royal Infirmary

    Leicester, LE15WW
    United Kingdom

    Site Not Available

  • Precision NextGen Oncology and Research Center

    Beverly Hills, California 90212
    United States

    Active - Recruiting

  • Valkyrie Clinical Trials

    Los Angeles, California 90067
    United States

    Active - Recruiting

  • PIH Health Hospital

    Whittier, California 90602
    United States

    Active - Recruiting

  • Woodlands Medical Specialists - Woodlands Center For Specialized Medicine

    Pensacola, Florida 32503-2339
    United States

    Site Not Available

  • Accellacare Duly

    Plainfield, Illinois 60585
    United States

    Active - Recruiting

  • Detroit Clinical Research Center, PC

    Farmington Hills, Michigan 48334
    United States

    Active - Recruiting

  • Stony Brook University Hospital

    Stony Brook, New York 11794
    United States

    Site Not Available

  • Millenium Research & Clinical Development

    Houston, Texas 77090
    United States

    Active - Recruiting

  • Texas Oncology, P.A

    San Antonio, Texas 78217
    United States

    Active - Recruiting

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

    Wytheville, Virginia 24382
    United States

    Active - Recruiting

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