Pharmacokinetic Similarity Between ABP 234 and Keytruda® (Pembrolizumab)

Phase 3

Recruiting

• Conditions: Early-stage Non-squamous Non-small Cell Lung Cancer (NSCLC)
• Interventions: Drug: ABP 234; Drug: Pembrolizumab

• Registration Number: NCT06430866
• Lead Sponsor: Amgen

Brief Summary

The primary objective of this study is to demonstrate pharmacokinetic (PK) similarity ABP 234 with pembrolizumab.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-15
• Study First Submitted QC: 2024-05-22
• Study First Posted: 2024-05-28
• Study Start: 2024-09-12
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-15
• Primary Completion: 2026-03-26
• Study Completion: 2027-02-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 154

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).
• Medical conditions requiring systemic immunosuppression.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ABP 234	ABP 234	Participants will receive ABP 234 every 3 weeks (Q3W) for up to 12 months.
Pembrolizumab	Pembrolizumab	Participants will receive pembrolizumab Q3W for up to 12 months.

Primary Outcome Measures

Name	Time	Method
Area Under the Serum Concentration-time Curve (AUC) From Time 0 to 21 Days (AUC21d) Following the First Dose	21 days
AUC at Steady State Between Week 16 and Week 19 (AUCtau_ss)	Weeks 16-19

Secondary Outcome Measures

Name	Time	Method
Tmax at Steady State (Tmax_ss)	Weeks 16-19
Maximum Observed Serum Concentration (Cmax) Following the First Dose (Cmax_dose1)	Up to 65 weeks
Number of Participants with Andit-drug Antibodies	Baseline and weeks 4, 7, 16, 19, 22, 28, 40, 52, and 65
Disease-free Survival	Up to 65 weeks
Trough Serum Concentrations (Ctrough) at Pre-dose of Week 4 (Ctrough_w4)	Week 4 pre-dose
Ctrough at Stead State (Ctrough_ss)	Weeks 16 and 19 pre-dose
Time to Maximum Serum Concentration (Tmax) Following the First Dose (Tmax_dose1)	Up to 65 weeks
Cmax at Steady State (Cmax_ss)	Weeks 16-19
Number of Participants with Treatment-emergent Adverse Events	Up to 16 months
Number of Participants with Treatment-emergent Serious Adverse Events	Up to 16 months
Number of Participants with Treatment-emergent Adverse Events of Interest (EOIs)	Up to 16 months

Trial Locations

Locations (106)

AUSL Della Romagna - Ospedale S.Maria delle Croci; 🇮🇹 Ravenna, Italy

Clincial Centre of Serbia; 🇷🇸 Belgrade, Serbia

University Multiprofile Hospital for Active Treatment Sofiamed; 🇧🇬 Sofia, Bulgaria

Centro de Investigaciones Clinicas Vina del Mar Ltda.; 🇨🇱 Vina del Mar, Region De Valparaiso, Chile

Clinica Santa Maria; 🇨🇱 Santiago, Region Metropolitana, Chile

Cdiem; 🇨🇱 Providencia, Region Metropolotana, Chile

Centro de Oncologa de Precisin; 🇨🇱 Region Metropolitana, Santiago, Chile

Centro de Investigacin de Enfermedades Respiratorias e Inmunologicas Limitada CIERI; 🇨🇱 Vina del Mar, Valparaiso, Chile

K2 Oncology; 🇨🇱 Santiago de Chile, Chile

Icegclinic Research and Care; 🇨🇱 Santiago, Chile

Clinique Belharra Ramsay Sante; 🇫🇷 Bayonne, France

Centre Hospitalier Universitaire de Bordeaux - Hopital Saint - Andre; 🇫🇷 Bordeaux, France

Centre Francois Baclesse; 🇫🇷 Caen, France

Hopital Europeen Marseille; 🇫🇷 Marseille, France

Hopital Bichat, APHP; 🇫🇷 Paris, France

Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (C.H.I.T.S) - Hopital Sainte Musse; 🇫🇷 Toulon, France

Hopital Robert Schuman; 🇫🇷 Vantoux, France

LLC Todua Clinic; 🇬🇪 Tbilisi, Georgia

New Hospitals; 🇬🇪 Tbilisi, Georgia

Studienzentrum Aschaffenburg; 🇩🇪 Aschaffenburg, Germany

Kliniken Essen Mitte, Evang. Huyssens-Stiftung, Internistische Onkologie und Hmatologie mit integire; 🇩🇪 Essen, Germany

Azienda Ospedaliera Universitaria Di Ferrara; 🇮🇹 Cona, Italy

Azienda Ospedaliera S. Croce e Carle; 🇮🇹 Cuneo, Italy

Azienda Ospedaliero-Universitaria Careggi; 🇮🇹 Firenze, Italy

Ospedale Versilia; 🇮🇹 Lucca, Italy

Azienda USL 2 Lucca; 🇮🇹 Lucca, Italy

ASL Napoli 1 Centro-Ospedale del Mare; 🇮🇹 Napoli, Italy

Casa Di Cura Polispecialistica Dott Pederzoli; 🇮🇹 Peschiera del Garda, Italy

IRCCS Istituto clinico humanitas - Humanitas Mirasole spa; 🇮🇹 Rozzano, Italy

Azienda Ospedaliera Santa Maria Terni; 🇮🇹 Terni, Italy

ASSt Sette Laghi; 🇮🇹 Varese, Italy

Chungbuk National University Hospital; 🇰🇷 Cheongju-si, Chungcheongbuk-do, Korea, Republic of

Ajou University Hospital; 🇰🇷 Suwon-si, Gyeonggi-do, Korea, Republic of

The Catholic University Of Korea, St. Vincent's Hospital; 🇰🇷 Suwon-si, Gyeonggi, Korea, Republic of

Jeonbuk National University Hospital; 🇰🇷 Jeonju-si, Jeollabuk-do, Korea, Republic of

Pusan National University Hospital (PNUH); 🇰🇷 Busan, Korea, Republic of

Gachon University Gil Medical Center; 🇰🇷 Incheon, Korea, Republic of

Kyung Hee University Hospital; 🇰🇷 Seoul, Korea, Republic of

Kangbuk Samsung Hospital; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center (AMC); 🇰🇷 Seoul, Korea, Republic of

Seoul Metropolitan Government - Seoul National University Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of

Hospital Raja Perempuan Zainab II; 🇲🇾 Kota Bharu, Kelantan, Malaysia

Hospital Umum Sarawak; 🇲🇾 Kuching, Sarawak, Malaysia

Hospital Canselor Tuanku Muhriz UKM; 🇲🇾 Cheras, Wilayah Persekutuan Kuala Lumpur, Malaysia

Centro Medico Dalinde; 🇲🇽 Roma, Cuauhtemoc Distrito Federal, Mexico

Investigacion Biomedica para el Desarrollo de Nuevos Farmacos SA de CV; 🇲🇽 Zapopan, Jalisco, Mexico

Accelerium Clinical Research; 🇲🇽 Monterrey, Nuevo Leon, Mexico

iCan Oncology Center S.A. de C.V.; 🇲🇽 Monterrey, Nuevo Leon, Mexico

Clinica Integral Internacional de Oncolgia S de RL de CV; 🇲🇽 Puebla, Mexico

Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy; 🇵🇱 Bydgoszcz, Kujawsko-Pomorskie, Poland

Specjalistyczne Gabinety Sp. z o.o; 🇵🇱 Krakow, Poland

Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu; 🇵🇱 Przemysl, Poland

Gyncentrum Szpital; 🇵🇱 Sosnowiec, Poland

Institutul Oncologic Prof. Dr. Ion Chiricuta; 🇷🇴 Cluj-Napoca, Cluj, Romania

Oncocenter Oncologie Clinica S.R.L; 🇷🇴 Timisoara, Timis, Romania

Oncomed; 🇷🇴 Timisoara, Timis, Romania

S.C. Medisprof S.R.L; 🇷🇴 Cluj-Napoca, Romania

Centrul de Oncologie Euroclinic srl; 🇷🇴 Jud. Iasi, Romania

Institute for Pulmonary Diseases of Vojvodina; 🇷🇸 Sremska Kamenica, Serbia

Centro Oncologico de Galicia; 🇪🇸 A Coruna Galicia, Spain

Complejo Hospitalario Universitario A Coruna; 🇪🇸 A Coruna, Spain

Hospital General Universitario de Elche; 🇪🇸 Alicante, Spain

Institut Catala d'Oncologia Badalona, Hospital Germans Trias I Pujol; 🇪🇸 Badalona, Spain

UOMI Cancer Center-Clinica Tres Torres; 🇪🇸 Barcelona, Spain

Hospital Quironsalud Barcelona; 🇪🇸 Barcelona, Spain

Hospital Universitari Quiron Dexeus Barcelona; 🇪🇸 Barcelona, Spain

Hospital Clinic de Barcelona (Hospital Clinic i Provincial); 🇪🇸 Barcelona, Spain

Hospital Universitario de Jerez; 🇪🇸 Jerez de la Frontera, Spain

Clinica MD Anderson International; 🇪🇸 Madrid, Spain

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain

Hospital Universitario Fundacion Jimenez Diaz; 🇪🇸 Madrid, Spain

Hospital Universitario Madrid Sanchinarro - Centro Integral Oncologico Clara Campal (CIOCC); 🇪🇸 Madrid, Spain

Hospital Universitario Fundacion Alcorcon; 🇪🇸 Madrid, Spain

Hospital De Mataro; 🇪🇸 Mataro, Spain

Hospital Quironsalud Malaga; 🇪🇸 Málaga, Spain

Complejo Hospitalario Universitario de Ourense; 🇪🇸 Ourense, Spain

Complejo Hospitalario Universitario De Santiago De Compostela; 🇪🇸 Santiago de Compostela, Spain

Hospital Universitario Virgen del Rocio; 🇪🇸 Seville, Spain

Hospital Universitario De Valme; 🇪🇸 Seville, Spain

Fundacion Instituto Valenciano de Oncologia; 🇪🇸 Valencia, Spain

Hospital Universitario Dr. Peset; 🇪🇸 Valencia, Spain

Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulev; 🇪🇸 Valencia, Spain

Hospital Clinico Univ Valladolid; 🇪🇸 Valladolid, Spain

National Taiwan University Hospital (NTUH); 🇨🇳 Taipei, Zhongzheng Dist, Taiwan

Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung County, Taiwan

Chung Shan Medical University Hospital; 🇨🇳 Taichung, Taiwan

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan

Mahidol University - Siriraj Hospital - Siriraj Clinical Research Center (SICRC); 🇹🇭 Bangkoknoi, Bangkok, Thailand

King Chulalongkorn Memorial Hospital, Chulalongkom University; 🇹🇭 Pathumwan, Bangkok, Thailand

Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University; 🇹🇭 Muang, Chiang Mai, Thailand

Lampang Cancer Hospital; 🇹🇭 Muang, Lampang, Thailand

Naresuan University Hospital; 🇹🇭 Muang, Phitsanulok, Thailand

Prince Of Songkla Hospital, Prince Of Songkhla University; 🇹🇭 Hat-Yai, Songkhla, Thailand

Vajira Hospital; 🇹🇭 Bangkok, Thailand

Gazi University Faculty of Medicine; 🇹🇷 Yenimahalle, Ankara, Turkey

Trakya University Faculty of Medicine; 🇹🇷 Iskender, Edirne, Turkey

Medical Park Seyhan Hospital; 🇹🇷 Adana, Turkey

Adana City Training and Research Hospinal; 🇹🇷 Adana, Turkey

Gulhane Training and Research Hospital; 🇹🇷 Ankara, Turkey

Memorial Ankara Hospital; 🇹🇷 Ankara, Turkey

Liv Hospital Ankara; 🇹🇷 Ankara, Turkey

Ankara Bilkent City Hospital; 🇹🇷 Ankara, Turkey

Uludag University Faculty of Medicine; 🇹🇷 Bursa, Turkey

Bezmialem Foundation University Medical Faculty; 🇹🇷 Istanbul, Turkey

Sakarya University - Faculty of Medicine; 🇹🇷 Sakarya, Turkey