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Cheaper keytruda clone tested for early lung cancer

NCT ID NCT06430866

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether ABP 234, a biosimilar to the cancer drug Keytruda, works the same in people with early-stage non-squamous lung cancer after surgery and chemotherapy. About 163 adults will receive either ABP 234 or Keytruda to compare how the drug behaves in the body. The goal is to see if ABP 234 can be a more affordable alternative.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ABP 234 (a biosimilar to pembrolizumab/Keytruda)
What this could lead to
If ABP 234 works as well as Keytruda, it could offer a more affordable treatment option for early-stage lung cancer after surgery.
What could go wrong
This is a similarity study, not a test of cure. Even if ABP 234 matches Keytruda, it may not improve outcomes, and biosimilars can have subtle differences in effectiveness or side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

163 people

The number who actually took part.

Started

Sep 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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: 1. Chemotherapy must have begun within 12 weeks after the resection surgery. 2. 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). Exclusion Criteria: * Evidence of disease. * Prior treatment with anti-programmed cell death protein 1 and anti-PD-L1/2 modulating agents in adjuvant setting. * History or presence of immune-mediated disorders. * Participants with type 1 diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or skin disorders not requiring systemic treatment are permitted to enroll. * Participant has positive screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C (HCV). * History of congenital immunodeficiency diseases, prior allogeneic stem cell transplantation, or organ transplantation. * History of any other malignancy other than NSCLC within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, papillary thyroid cancer treated with surgery, etc. * Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including active viral or other hepatitis virus, current alcohol abuse or cirrhosis. * Surgery or chemotherapy-related toxicity not resolved to grade 1 with the exception of grade ≤ 2 alopecia, fatigue, neuropathy, and lack of appetite/nausea. * Woman of childbearing potential who is pregnant or is breast feeding. * Woman of childbearing potential who is not consenting to use highly effective methods of birth control. * Man with a partner of childbearing potential who does not consent to use highly effective methods of birth control. * Participant has known hypersensitivity to monoclonal antibodies or to any of the excipients of the investigational product (IP). * Active cardiac disease or history of cardiac dysfunction, that in the judgment of the investigator would place the participant at additional risk when participating in the study. * Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current neumonitis/interstitial lung disease. * Live vaccine therapy within 4 weeks prior to IP administration. * Participation in another investigational drug study within 30 days prior to IP administration.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Early-stage non-squamous non-small cell lung cancer (NSCLC)

Contacts and locations

Locations

  • AOU Cagliari-Policlinico Universitario Duilio Casula di Monserrato-UOC Oncologia Medica

    Monserrato, 09042, Italy

  • ASL Napoli 1 Centro-Ospedale del Mare

    Naples, 80147, Italy

  • ASST Sette Laghi

    Varese, 2110, Italy

  • AUSL Della Romagna - Ospedale S.Maria delle Croci

    Ravenna, 48121, Italy

  • Accelerium Clinical Research

    Monterrey, Nuevo León, 64000, Mexico

  • Adana City Training and Research Hospital

    Adana, 4522, Turkey (Türkiye)

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 16499, South Korea

  • Ankara Bilkent City Hospital

    Ankara, 06800, Turkey (Türkiye)

  • Ankara Universitesi Tip Fakultesi Cebeci Hastanesi

    Ankara, 06100, Turkey (Türkiye)

  • Asan Medical Center (AMC)

    Seoul, 05505, South Korea

  • Azienda Ospedaliera S. Croce e Carle

    Cuneo, 12100, Italy

  • Azienda Ospedaliera Santa Maria Terni

    Terni, 05100, Italy

  • Azienda Ospedaliero - Universitaria di Ferrara

    Cona, 44124, Italy

  • Azienda Ospedaliero-Universitaria Careggi

    Florence, 50134, Italy

  • Azienda USL 2 Lucca

    Lucca, 55100, Italy

  • Baskent University Ankara Hospital

    Ankara, 6490, Turkey (Türkiye)

  • Bezmialem Foundation University Medical Faculty

    Istanbul, 34093, Turkey (Türkiye)

  • CDIEM - Centro de Investigacion y Especialidades Medicas

    Providencia, Region Metropolotana, 7500859, Chile

  • Casa Di Cura Polispecialistica Dott Pederzoli

    Peschiera del Garda, 37019, Italy

  • Cebu Doctors University Hospital

    Cebu City, Cebu, 6000, Philippines

  • Centre Francois Baclesse

    Caen, 14076, France

  • Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (C.H.I.T.S) - Hopital Sainte Musse

    Toulon, 83056, France

  • Centre Hospitalier Universitaire de Bordeaux - Hopital Saint - Andre

    Bordeaux, 33075, France

  • Centro Medico Dalinde

    Cuauhtémoc, Mexico City, 06760, Mexico

  • Centro Oncologico de Galicia

    A Coruna Galicia, 15009, Spain

  • Centro de Investigacin de Enfermedades Respiratorias e Inmunologicas Limitada CIERI

    Viña del Mar, Valparaiso, 2520598, Chile

  • Centro de Investigaciones Clinicas Vina del Mar Ltda.

    Viña Del Mar, Valparaiso, 2540364, Chile

  • Centro de Oncologia de Precision

    Region Metropolitana, Santiago Metropolitan, 7560908, Chile

  • Centrul de Oncologie Euroclinic srl

    Jud. Iasi, 700106, Romania

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

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

  • Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung County, 83301, Taiwan

  • Chung Shan Medical University Hospital

    Taichung, 40201, Taiwan

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong, 28644, South Korea

  • Clincial Centre of Serbia

    Belgrade, 11000, Serbia

  • Clinica Integral Internacional de Oncolgia S de RL de CV

    Puebla City, 72530, Mexico

  • Clinica MD Anderson International

    Madrid, 28033, Spain

  • Clinica Santa Maria

    Santiago, Santiago Metropolitan, 7520349, Chile

  • Clinique Belharra Ramsay Sante

    Bayonne, 64100, France

  • Complejo Hospitalario Universitario A Coruna

    A Coruña, 15006, Spain

  • Complejo Hospitalario Universitario De Santiago De Compostela

    Santiago de Compostela, 15706, Spain

  • Complejo Hospitalario Universitario de Ourense

    Ourense, 32005, Spain

  • Davao Doctors Hospital

    Davao City, Davao Del Sur, 8000, Philippines

  • Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

    Ankara, 06200, Turkey (Türkiye)

  • Faculty of Medicine Vajira Hospital, Navamindradhiraj University

    Bangkok, 10300, Thailand

  • Fundacion ARS Medica

    San Salvador de Jujuy, Jujuy Province, 4600, Argentina

  • Fundacion Instituto Valenciano de Oncologia

    Valencia, 46009, Spain

  • Gachon University Gil Medical Center

    Incheon, 21565, South Korea

  • Gazi University Faculty of Medicine

    Yenimahalle, Ankara, 06560, Turkey (Türkiye)

  • Gulhane Training and Research Hospital

    Ankara, 06010, Turkey (Türkiye)

  • Gyncentrum Szpital

    Sosnowiec, 41-208, Poland

  • Hopital Bichat, APHP

    Paris, 75018, France

  • Hopital Europeen Marseille

    Marseille, 13003, France

  • Hopital Robert Schuman

    Vantoux, 57070, France

  • Hospital Canselor Tuanku Muhriz UKM

    Cheras, Kuala Lumpur, 56000, Malaysia

  • Hospital Clinic de Barcelona (Hospital Clinic i Provincial)

    Barcelona, 08036, Spain

  • Hospital Clinico Univ Valladolid

    Valladolid, 47003, Spain

  • Hospital De Mataro

    Mataró, 08304, Spain

  • Hospital Fundacion Jimenez Diaz

    Madrid, 28040, Spain

  • Hospital General Universitario de Elche

    Alicante, 03203, Spain

  • Hospital Quironsalud Barcelona

    Barcelona, 08023, Spain

  • Hospital Quironsalud Malaga

    Málaga, 29004, Spain

  • Hospital Umum Sarawak

    Kuching, Sarawak, 93586, Malaysia

  • Hospital Universitari Quiron Dexeus Barcelona

    Barcelona, 08028, Spain

  • Hospital Universitario De Valme

    Seville, 41014, Spain

  • Hospital Universitario Dr. Peset

    Valencia, 46017, Spain

  • Hospital Universitario Fundacion Alcorcon

    Madrid, 28922, Spain

  • Hospital Universitario Madrid Sanchinarro - Centro Integral Oncologico Clara Campal (CIOCC)

    Madrid, 28050, Spain

  • Hospital Universitario San Carlos

    Madrid, 28040, Spain

  • Hospital Universitario San Francisco de Asis

    Madrid, 28002, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • Hospital Universitario de Jerez

    Jerez de la Frontera, 11404, Spain

  • IRCCS Istituto clinico humanitas - Humanitas Mirasole spa

    Rozzano, 20089, Italy

  • Icegclinic Research and Care

    Santiago, Chile

  • Institut Catala d'Oncologia Badalona, Hospital Germans Trias I Pujol

    Badalona, 08916, Spain

  • Institute for Pulmonary Diseases of Vojvodina

    Kamenitz, 21204, Serbia

  • Instituto Oncologico Fundacion Arturo Lopez Perez (FALP)

    Providencia, Santiago Metropolitan, 7500921, Chile

  • Instituto de Oncologia de Rosario

    Rosario, Santa Fe Province, S2000KZE, Argentina

  • Institutul Oncologic Prof. Dr. Ion Chiricuta

    Cluj-Napoca, Cluj, 400015, Romania

  • Investigacion Biomedica para el Desarrollo de Nuevos Farmacos SA de CV

    Zapopan, Jalisco, 45070, Mexico

  • Ionc Instituto Oncologico De Cordoba

    Córdoba, X5000HWE, Argentina

  • Jeonbuk National University Hospital

    Jeonju, Jeollabuk-do, 54907, South Korea

  • K2 Oncology

    Santiago, 2330, Chile

  • Kangbuk Samsung Hospital

    Seoul, 03181, South Korea

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807, Taiwan

  • King Chulalongkorn Memorial Hospital, Chulalongkom University

    Pathumwan, Bangkok, 10330, Thailand

  • Kliniken Essen Mitte, Evang. Huyssens-Stiftung, Internistische Onkologie und Hmatologie mit integire

    Essen, 45276, Germany

  • Korea University Guro Hospital

    Seoul, 08308, South Korea

  • Kyung Hee University Hospital

    Seoul, 02447, South Korea

  • LLC Todua Clinic

    Tbilisi, 0112, Georgia

  • Lampang Cancer Hospital

    Muang, Changwat Lampang, 52000, Thailand

  • Liv Hospital Ankara

    Ankara, 06680, Turkey (Türkiye)

  • Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University

    Muang, Chiang Mai, 52000, Thailand

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

    Bangkoknoi, Bangkok, 10700, Thailand

  • Makati Medical Center

    Makati City, National Capital Region, 1229, Philippines

  • Medical Park Seyhan Hospital

    Adana, 01230, Turkey (Türkiye)

  • Medical Point Gaziantep Hospital

    Gaziantep, 27584, Turkey (Türkiye)

  • Memorial Ankara Hospital

    Ankara, 06520, Turkey (Türkiye)

  • Naresuan University Hospital

    Muang, Changwat Phitsanulok, 65000, Thailand

  • National Cheng Kung University

    Tainan, 701, Taiwan

  • National Taiwan University Hospital (NTUH)

    Taipei, Zhongzheng Dist, 10050, Taiwan

  • New Hospitals

    Tbilisi, 0114, Georgia

  • Onco Pall Advance Care Oncology Center Sa de CV

    Monterrey, Nuevo León, 64320, Mexico

  • Oncocenter Oncologie Clinica S.R.L

    Timișoara, Timiș County, 300210, Romania

  • Oncomed

    Timișoara, Timiș County, 300239, Romania

  • Ospedale Versilia

    Lucca, 55043, Italy

  • Philippine General Hospital

    Manila, 1000, Philippines

  • Preparaciones Oncolgicas S.C.

    León, Guanajuato, 37178, Mexico

  • Prince Of Songkla Hospital, Prince Of Songkhla University

    Hat Yai, Changwat Songkhla, 90110, Thailand

  • Pusan National University Hospital (PNUH)

    Busan, 49241, South Korea

  • Raja Perempuan Zainab II Hospital

    Kota Bharu, Kelantan, 15586, Malaysia

  • Riverside Medical Center Inc

    Bacolod City, Negros Occidental, 6100, Philippines

  • S.C. Medisprof S.R.L

    Cluj-Napoca, 400641, Romania

  • Sakarya University - Faculty of Medicine

    Sakarya, 54290, Turkey (Türkiye)

  • Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

    Lublin, Lublin Voivodeship, 20-954, Poland

  • Seoul Metropolitan Government - Seoul National University Boramae Medical Center

    Seoul, 07061, South Korea

  • Specjalistyczne Gabinety Sp. z o.o

    Krakow, 30-539, Poland

  • Studienzentrum Aschaffenburg

    Aschaffenburg, 63739, Germany

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

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

    Suwon, Gyeonggi-do, 16247, South Korea

  • Trakya University Faculty of Medicine

    İskender, Edirne, 22130, Turkey (Türkiye)

  • UOMI Cancer Center-Clinica Tres Torres

    Barcelona, 08017, Spain

  • Uludag University Faculty of Medicine

    Bursa, 16059, Turkey (Türkiye)

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

    Valencia, 46026, Spain

  • University Multiprofile Hospital for Active Treatment Sofiamed

    Sofia, 1797, Bulgaria

  • Veterans Memorial Medical Center

    Quezon City, National Capital Region, 1110, Philippines

  • Warminsko Mazurskie Centrum Chorob Pluc w Olsztynie

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

  • Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu

    Przemyśl, 37-700, Poland

  • iCan Oncology Center S.A. de C.V.

    Monterrey, Nuevo León, 64710, Mexico