Clinical trial NCT06430866: Pharmacokinetic Similarity Between ABP 234 and Keytruda® (Pembrolizumab)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Early-stage Non-squamous Non-small Cell Lung Cancer (NSCLC)
Keywords: NSCLC
Keytruda
Pembrolizumab
ABP 234
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2024-05-28
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Area Under the Serum Concentration-time Curve (AUC) From Time 0 to 21 Days (AUC21d) Following the First Dose
timeFrame: 21 days
measure: AUC at Steady State Between Week 16 and Week 19 (AUCtau_ss)
timeFrame: Weeks 16-19
Secondary outcomes:
measure: Maximum Observed Serum Concentration (Cmax) Following the First Dose (Cmax_dose1)
timeFrame: Up to 65 weeks
measure: Time to Maximum Serum Concentration (Tmax) Following the First Dose (Tmax_dose1)
timeFrame: Up to 65 weeks
measure: Cmax at Steady State (Cmax_ss)
timeFrame: Weeks 16-19
measure: Tmax at Steady State (Tmax_ss)
timeFrame: Weeks 16-19
measure: Trough Serum Concentrations (Ctrough) at Pre-dose of Week 4 (Ctrough_w4)
timeFrame: Week 4 pre-dose
measure: Ctrough at Stead State (Ctrough_ss)
timeFrame: Weeks 16 and 19 pre-dose
measure: Number of Participants with Treatment-emergent Adverse Events
timeFrame: Up to 16 months
measure: Number of Participants with Treatment-emergent Serious Adverse Events
timeFrame: Up to 16 months
measure: Number of Participants with Treatment-emergent Adverse Events of Interest (EOIs)
timeFrame: Up to 16 months
measure: Number of Participants with Andit-drug Antibodies
timeFrame: Baseline and weeks 4, 7, 16, 19, 22, 28, 40, 52, and 65
measure: Disease-free Survival
timeFrame: Up to 65 weeks
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Sofiamed
city: Vina del Mar
country: Chile
facility: Centro de Investigaciones Clinicas Vina del Mar Ltda.
state: Region De Valparaiso
city: Santiago de Chile
country: Chile
facility: K2 Oncology
state: Region Metropolitana
city: Santiago
country: Chile
facility: Clinica Santa Maria
state: Region Metropolitana
city: Providencia
country: Chile
facility: Cdiem
state: Region Metropolotana
city: Region Metropolitana
country: Chile
facility: Centro de Oncologa de Precisin
state: Santiago
city: Vina Del Mar
country: Chile
facility: Centro de Investigacin de Enfermedades Respiratorias e Inmunologicas Limitada CIERI
state: Valparaiso
city: Santiago
country: Chile
facility: Icegclinic Research and Care
city: Bayonne
country: France
facility: Clinique Belharra Ramsay Sante
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire de Bordeaux - Hopital Saint - Andre
city: Caen
country: France
facility: Centre Francois Baclesse
city: Marseille
country: France
facility: Hopital Europeen Marseille
city: Paris
country: France
facility: Hopital Bichat, APHP
city: Toulon
country: France
facility: Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (C.H.I.T.S) - Hopital Sainte Musse
city: Vantoux
country: France
facility: Hopital Robert Schuman
city: Tbilisi
country: Georgia
facility: LLC Todua Clinic
city: Tbilisi
country: Georgia
facility: New Hospitals
city: Aschaffenburg
country: Germany
facility: Studienzentrum Aschaffenburg
city: Essen
country: Germany
facility: Kliniken Essen Mitte, Evang. Huyssens-Stiftung, Internistische Onkologie und Hmatologie mit integire
city: Cona
country: Italy
facility: Azienda Ospedaliera Universitaria Di Ferrara
city: Cuneo
country: Italy
facility: Azienda Ospedaliera S. Croce e Carle
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi
city: Lucca
country: Italy
facility: Ospedale Versilia
city: Lucca
country: Italy
facility: Azienda USL 2 Lucca
city: Napoli
country: Italy
facility: ASL Napoli 1 Centro-Ospedale del Mare
city: Peschiera del Garda
country: Italy
facility: Casa Di Cura Polispecialistica Dott Pederzoli
city: Ravenna
country: Italy
facility: AUSL Della Romagna - Ospedale S.Maria delle Croci
city: Rozzano
country: Italy
facility: IRCCS Istituto clinico humanitas - Humanitas Mirasole spa
city: Terni
country: Italy
facility: Azienda Ospedaliera Santa Maria Terni
city: Varese
country: Italy
facility: ASSt Sette Laghi
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
state: Chungcheongbuk-do
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University Of Korea, St. Vincent's Hospital
state: Gyeonggi
city: Jeonju-si
country: Korea, Republic of
facility: Jeonbuk National University Hospital
state: Jeollabuk-do
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital (PNUH)
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center (AMC)
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government - Seoul National University Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Kota Bharu
country: Malaysia
facility: Hospital Raja Perempuan Zainab II
state: Kelantan
city: Kuching
country: Malaysia
facility: Hospital Umum Sarawak
state: Sarawak
city: Cheras
country: Malaysia
facility: Hospital Canselor Tuanku Muhriz UKM
state: Wilayah Persekutuan Kuala Lumpur
city: Cuauhtemoc
country: Mexico
facility: Centro Medico Dalinde
state: Ciudad De Mexico
city: Zapopan
country: Mexico
facility: Investigacion Biomedica para el Desarrollo de Nuevos Farmacos SA de CV
state: Jalisco
city: Monterrey
country: Mexico
facility: Accelerium Clinical Research
state: Nuevo Leon
city: Monterrey
country: Mexico
facility: iCan Oncology Center S.A. de C.V.
state: Nuevo Leon
city: Puebla
country: Mexico
facility: Clinica Integral Internacional de Oncolgia S de RL de CV
city: Davao
country: Philippines
facility: Davao Doctors Hospital
state: Davao Del Sur
city: Bacolod City
country: Philippines
facility: Riverside Medical Center Inc
state: Negros Occidental
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy
state: Kujawsko-Pomorskie
city: Olsztyn
country: Poland
facility: Warminsko Mazurskie Centrum Chorob Pluc w Olsztynie
state: Warminsko-mazurskie
city: Krakow
country: Poland
facility: Specjalistyczne Gabinety Sp. z o.o
city: Przemysl
country: Poland
facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu
city: Sosnowiec
country: Poland
facility: Gyncentrum Szpital
city: Cluj-Napoca
country: Romania
facility: Institutul Oncologic Prof. Dr. Ion Chiricuta
state: Cluj
city: Timisoara
country: Romania
facility: Oncocenter Oncologie Clinica S.R.L
state: Timis
city: Timisoara
country: Romania
facility: Oncomed
state: Timis
city: Cluj-Napoca
country: Romania
facility: S.C. Medisprof S.R.L
city: Jud. Iasi
country: Romania
facility: Centrul de Oncologie Euroclinic srl
city: Belgrade
country: Serbia
facility: Clincial Centre of Serbia
city: Sremska Kamenica
country: Serbia
facility: Institute for Pulmonary Diseases of Vojvodina
city: A Coruna Galicia
country: Spain
facility: Centro Oncologico de Galicia
city: A Coruna
country: Spain
facility: Complejo Hospitalario Universitario A Coruna
city: Alicante
country: Spain
facility: Hospital General Universitario de Elche
city: Badalona
country: Spain
facility: Institut Catala d'Oncologia Badalona, Hospital Germans Trias I Pujol
city: Barcelona
country: Spain
facility: UOMI Cancer Center-Clinica Tres Torres
city: Barcelona
country: Spain
facility: Hospital Quironsalud Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari Quiron Dexeus Barcelona
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona (Hospital Clinic i Provincial)
city: Jerez de la Frontera
country: Spain
facility: Hospital Universitario de Jerez
city: Madrid
country: Spain
facility: Clinica MD Anderson International
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Universitario Madrid Sanchinarro - Centro Integral Oncologico Clara Campal (CIOCC)
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Alcorcon
city: Mataro
country: Spain
facility: Hospital De Mataro
city: MÃ¡laga
country: Spain
facility: Hospital Quironsalud Malaga
city: Ourense
country: Spain
facility: Complejo Hospitalario Universitario de Ourense
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario De Santiago De Compostela
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Seville
country: Spain
facility: Hospital Universitario De Valme
city: Valencia
country: Spain
facility: Fundacion Instituto Valenciano de Oncologia
city: Valencia
country: Spain
facility: Hospital Universitario Dr. Peset
city: Valencia
country: Spain
facility: Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulev
city: Valladolid
country: Spain
facility: Hospital Clinico Univ Valladolid
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital (NTUH)
state: Zhongzheng Dist
city: Kaohsiung County
country: Taiwan
facility: Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Bangkoknoi
country: Thailand
facility: Mahidol University - Siriraj Hospital - Siriraj Clinical Research Center (SICRC)
state: Bangkok
city: Pathumwan
country: Thailand
facility: King Chulalongkorn Memorial Hospital, Chulalongkom University
state: Bangkok
city: Muang
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University
state: Chiang Mai
city: Muang
country: Thailand
facility: Lampang Cancer Hospital
state: Lampang
city: Muang
country: Thailand
facility: Naresuan University Hospital
state: Phitsanulok
city: Hat-Yai
country: Thailand
facility: Prince Of Songkla Hospital, Prince Of Songkhla University
state: Songkhla
city: Bangkok
country: Thailand
facility: Vajira Hospital
city: Yenimahalle
country: Turkey
facility: Gazi University Faculty of Medicine
state: Ankara
city: Iskender
country: Turkey
facility: Trakya University Faculty of Medicine
state: Edirne
city: Adana
country: Turkey
facility: Medical Park Seyhan Hospital
city: Adana
country: Turkey
facility: Adana City Training and Research Hospital
city: Ankara
country: Turkey
facility: Gulhane Training and Research Hospital
city: Ankara
country: Turkey
facility: Memorial Ankara Hospital
city: Ankara
country: Turkey
facility: Liv Hospital Ankara
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
city: Ankara
country: Turkey
facility: Baskent University Ankara Hospital
city: Bursa
country: Turkey
facility: Uludag University Faculty of Medicine
city: Gaziantep
country: Turkey
facility: Medical Point Gaziantep Hospital
city: Istanbul
country: Turkey
facility: Bezmialem Foundation University Medical Faculty
city: Sakarya
country: Turkey
facility: Sakarya University - Faculty of Medicine
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: