Early-stage Non-squamous Non-small Cell Lung Cancer (NSCLC)Phase 3EucalyptusNCT06430866
Pharmacokinetic Similarity Between ABP 234 and Keytruda® (Pembrolizumab)
A Phase 3 study testing ABP 234 and Pembrolizumab in people with Early-stage Non-squamous Non-small Cell Lung Cancer (NSCLC), run by Amgen at 128 sites in 18 countries.
Trial summary
The primary objective of this study is to demonstrate pharmacokinetic (PK) similarity ABP 234 with pembrolizumab. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Early-stage Non-squamous Non-small Cell Lung Cancer (NSCLC)
- What is being tested?
- ABP 234 and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 128 sitesin 18 countries
- Study dates
- 12 Sep 2024to 14 Dec 2026
- Phase
- Phase 3
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
- 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:
- Chemotherapy must have begun within 12 weeks after the resection surgery.
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- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
128 sites in 18 countries.
128 sites in 18 countries
Spain25 sites
Complejo Hospitalario Universitario A Coruna
A Coruña, 15006
Centro Oncologico de Galicia
A Coruna Galicia, 15009
Hospital General Universitario de Elche
Alicante, 03203
Institut Catala d'Oncologia Badalona, Hospital Germans Trias I Pujol
Badalona, 08916
UOMI Cancer Center-Clinica Tres Torres
Barcelona, 08017
Hospital Quironsalud Barcelona
Barcelona, 08023
Hospital Universitari Quiron Dexeus Barcelona
Barcelona, 08028
Hospital Clinic de Barcelona (Hospital Clinic i Provincial)
Barcelona, 08036
Hospital Universitario de Jerez
Jerez de la Frontera, 11404
Hospital Quironsalud Malaga
Málaga, 29004
Hospital Universitario San Francisco de Asis
Madrid, 28002
Clinica MD Anderson International
Madrid, 28033
Hospital Fundacion Jimenez Diaz
Madrid, 28040
Hospital Universitario San Carlos
Madrid, 28040
Hospital Universitario Madrid Sanchinarro - Centro Integral Oncologico Clara Campal (CIOCC)
Madrid, 28050
Hospital Universitario Fundacion Alcorcon
Madrid, 28922
Hospital De Mataro
Mataró, 08304
Complejo Hospitalario Universitario de Ourense
Ourense, 32005
Complejo Hospitalario Universitario De Santiago De Compostela
Santiago de Compostela, 15706
Hospital Universitario Virgen del Rocio
Seville, 41013
Hospital Universitario De Valme
Seville, 41014
Fundacion Instituto Valenciano de Oncologia
Valencia, 46009
Hospital Universitario Dr. Peset
Valencia, 46017
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulev
Valencia, 46026
Hospital Clinico Univ Valladolid
Valladolid, 47003
Turkey (Türkiye)15 sites
Medical Park Seyhan Hospital
Adana, 01230
Adana City Training and Research Hospital
Adana, 4522
Gulhane Training and Research Hospital
Ankara, 06010
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
Baskent University Ankara Hospital
Ankara, 6490
Uludag University Faculty of Medicine
Bursa, 16059
Medical Point Gaziantep Hospital
Gaziantep, 27584
Trakya University Faculty of Medicine
İskender, Edirne, 22130
Bezmialem Foundation University Medical Faculty
Istanbul, 34093
Sakarya University - Faculty of Medicine
Sakarya, 54290
Gazi University Faculty of Medicine
Yenimahalle, Ankara, 06560
Italy12 sites
Azienda Ospedaliero - Universitaria di Ferrara
Cona, 44124
Azienda Ospedaliera S. Croce e Carle
Cuneo, 12100
Azienda Ospedaliero-Universitaria Careggi
Florence, 50134
Ospedale Versilia
Lucca, 55043
Azienda USL 2 Lucca
Lucca, 55100
AOU Cagliari-Policlinico Universitario Duilio Casula di Monserrato-UOC Oncologia Medica
Monserrato, 09042
ASL Napoli 1 Centro-Ospedale del Mare
Naples, 80147
Casa Di Cura Polispecialistica Dott Pederzoli
Peschiera del Garda, 37019
AUSL Della Romagna - Ospedale S.Maria delle Croci
Ravenna, 48121
IRCCS Istituto clinico humanitas - Humanitas Mirasole spa
Rozzano, 20089
Azienda Ospedaliera Santa Maria Terni
Terni, 05100
ASST Sette Laghi
Varese, 2110
South Korea11 sites
Pusan National University Hospital (PNUH)
Busan, 49241
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, 28644
Gachon University Gil Medical Center
Incheon, 21565
Jeonbuk National University Hospital
Jeonju, Jeollabuk-do, 54907
Kyung Hee University Hospital
Seoul, 02447
Kangbuk Samsung Hospital
Seoul, 03181
Asan Medical Center (AMC)
Seoul, 05505
Seoul Metropolitan Government - Seoul National University Boramae Medical Center
Seoul, 07061
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
Chile8 sites
CDIEM - Centro de Investigacion y Especialidades Medicas
Providencia, Region Metropolotana, 7500859
Instituto Oncologico Fundacion Arturo Lopez Perez (FALP)
Providencia, Santiago Metropolitan, 7500921
Centro de Oncologia de Precision
Region Metropolitana, Santiago Metropolitan, 7560908
Clinica Santa Maria
Santiago, Santiago Metropolitan, 7520349
K2 Oncology
Santiago, 2330
Icegclinic Research and Care
Santiago
Centro de Investigaciones Clinicas Vina del Mar Ltda.
Viña Del Mar, Valparaiso, 2540364
Centro de Investigacin de Enfermedades Respiratorias e Inmunologicas Limitada CIERI
Viña del Mar, Valparaiso, 2520598
France7 sites
Clinique Belharra Ramsay Sante
Bayonne, 64100
Centre Hospitalier Universitaire de Bordeaux - Hopital Saint - Andre
Bordeaux, 33075
Centre Francois Baclesse
Caen, 14076
Hopital Europeen Marseille
Marseille, 13003
Hopital Bichat, APHP
Paris, 75018
Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (C.H.I.T.S) - Hopital Sainte Musse
Toulon, 83056
Hopital Robert Schuman
Vantoux, 57070
Mexico7 sites
Centro Medico Dalinde
Cuauhtémoc, Mexico City, 06760
Preparaciones Oncolgicas S.C.
León, Guanajuato, 37178
Accelerium Clinical Research
Monterrey, Nuevo León, 64000
Onco Pall Advance Care Oncology Center Sa de CV
Monterrey, Nuevo León, 64320
iCan Oncology Center S.A. de C.V.
Monterrey, Nuevo León, 64710
Clinica Integral Internacional de Oncolgia S de RL de CV
Puebla City, 72530
Investigacion Biomedica para el Desarrollo de Nuevos Farmacos SA de CV
Zapopan, Jalisco, 45070
Thailand7 sites
Faculty of Medicine Vajira Hospital, Navamindradhiraj University
Bangkok, 10300
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
Lampang Cancer Hospital
Muang, Changwat Lampang, 52000
Naresuan University Hospital
Muang, Changwat Phitsanulok, 65000
Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University
Muang, Chiang Mai, 52000
King Chulalongkorn Memorial Hospital, Chulalongkom University
Pathumwan, Bangkok, 10330
Philippines6 sites
Riverside Medical Center Inc
Bacolod City, Negros Occidental, 6100
Cebu Doctors University Hospital
Cebu City, Cebu, 6000
Davao Doctors Hospital
Davao City, Davao Del Sur, 8000
Makati Medical Center
Makati City, National Capital Region, 1229
Philippine General Hospital
Manila, 1000
Veterans Memorial Medical Center
Quezon City, National Capital Region, 1110
Poland6 sites
Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796
Specjalistyczne Gabinety Sp. z o.o
Krakow, 30-539
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
Lublin, Lublin Voivodeship, 20-954
Warminsko Mazurskie Centrum Chorob Pluc w Olsztynie
Olsztyn, Warmian-Masurian Voivodeship, 10-357
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu
Przemyśl, 37-700
Gyncentrum Szpital
Sosnowiec, 41-208
Taiwan6 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
Kaohsiung County, 83301
Chung Shan Medical University Hospital
Taichung, 40201
National Cheng Kung University
Tainan, 701
National Taiwan University Hospital (NTUH)
Taipei, Zhongzheng Dist, 10050
Taipei Veterans General Hospital
Taipei, 11217
Romania5 sites
Institutul Oncologic Prof. Dr. Ion Chiricuta
Cluj-Napoca, Cluj, 400015
S.C. Medisprof S.R.L
Cluj-Napoca, 400641
Centrul de Oncologie Euroclinic srl
Jud. Iasi, 700106
Oncocenter Oncologie Clinica S.R.L
Timișoara, Timiș County, 300210
Oncomed
Timișoara, Timiș County, 300239
Argentina3 sites
Ionc Instituto Oncologico De Cordoba
Córdoba, X5000HWE
Instituto de Oncologia de Rosario
Rosario, Santa Fe Province, S2000KZE
Fundacion ARS Medica
San Salvador de Jujuy, Jujuy Province, 4600
Malaysia3 sites
Hospital Canselor Tuanku Muhriz UKM
Cheras, Kuala Lumpur, 56000
Raja Perempuan Zainab II Hospital
Kota Bharu, Kelantan, 15586
Hospital Umum Sarawak
Kuching, Sarawak, 93586
Germany2 sites
Studienzentrum Aschaffenburg
Aschaffenburg, 63739
Kliniken Essen Mitte, Evang. Huyssens-Stiftung, Internistische Onkologie und Hmatologie mit integire
Essen, 45276
Serbia2 sites
Clincial Centre of Serbia
Belgrade, 11000
Institute for Pulmonary Diseases of Vojvodina
Kamenitz, 21204
Bulgaria1 site
University Multiprofile Hospital for Active Treatment Sofiamed
Sofia, 1797
About this study
Official title: A Randomized, Double-blind Study to Compare the Pharmacokinetics Between ABP 234 and Keytruda® (Pembrolizumab) in Participants With Early-stage Non-squamous Non-small Cell Lung Cancer as Adjuvant Treatment Following Resection and Platinum-based Chemotherapy
The primary objective of this study is to demonstrate pharmacokinetic (PK) similarity ABP 234 with pembrolizumab.
- Being tested
- ABP 234, Pembrolizumab
- Keywords
- NSCLC, Keytruda, Pembrolizumab, ABP 234
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABP 234Drug
Administered by intravenous (IV) injection.
PembrolizumabDrug
Administered by IV injection.
| Study group | Role | What they receive |
|---|---|---|
| ABP 234 | Experimental | Participants will receive ABP 234 every 3 weeks (Q3W) for up to 12 months. Receives: Drug: ABP 234 |
| Pembrolizumab | Active comparator | Participants will receive pembrolizumab Q3W for up to 12 months. Receives: Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Serum Concentration-time Curve (AUC) From Time 0 to 21 Days (AUC21d) Following the First Dose
Measured: 21 days
AUC at Steady State Between Week 16 and Week 19 (AUCtau_ss)
Measured: Weeks 16-19
Secondary outcomes (11)
Maximum Observed Serum Concentration (Cmax) Following the First Dose (Cmax_dose1)
Measured: Up to 65 weeks
Time to Maximum Serum Concentration (Tmax) Following the First Dose (Tmax_dose1)
Measured: Up to 65 weeks
Cmax at Steady State (Cmax_ss)
Measured: Weeks 16-19
Tmax at Steady State (Tmax_ss)
Measured: Weeks 16-19
Trough Serum Concentrations (Ctrough) at Pre-dose of Week 4 (Ctrough_w4)
Measured: Week 4 pre-dose
Ctrough at Stead State (Ctrough_ss)
Measured: Weeks 16 and 19 pre-dose
Number of Participants with Treatment-emergent Adverse Events
Measured: Up to 16 months
Number of Participants with Treatment-emergent Serious Adverse Events
Measured: Up to 16 months
Number of Participants with Treatment-emergent Adverse Events of Interest (EOIs)
Measured: Up to 16 months
Number of Participants with Andit-drug Antibodies
Measured: Baseline and weeks 4, 7, 16, 19, 22, 28, 40, 52, and 65
Disease-free Survival
Measured: Up to 65 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start12 Sep 2024
- Primary completion14 Dec 2026 (estimated)
- Study completion14 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early-stage Non-squamous Non-small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06430866
- Sponsor's protocol ID
- 20230127
- Acronym
- Eucalyptus
- Status last verified
- Mar 2026
- First submitted
- 15 Mar 2024
- Last updated
- 1 Apr 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.