Trial Title:
Pharmacokinetic Similarity Between ABP 234 and Keytruda® (Pembrolizumab)
NCT ID:
NCT06430866
Condition:
Early-stage Non-squamous Non-small Cell Lung Cancer (NSCLC)
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Pembrolizumab
Conditions: Keywords:
NSCLC
Keytruda
Pembrolizumab
ABP 234
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
ABP 234
Description:
Administered by intravenous (IV) injection.
Arm group label:
ABP 234
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
Administered by IV injection.
Arm group label:
Pembrolizumab
Summary:
The primary objective of this study is to demonstrate pharmacokinetic (PK) similarity ABP
234 with pembrolizumab.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University Multiprofile Hospital for Active Treatment Sofiamed
Address:
City:
Sofia
Zip:
1797
Country:
Bulgaria
Status:
Recruiting
Facility:
Name:
Centro de Investigaciones Clinicas Vina del Mar Ltda.
Address:
City:
Vina del Mar
Zip:
2540364
Country:
Chile
Status:
Recruiting
Facility:
Name:
Cdiem
Address:
City:
Providencia
Zip:
7500859
Country:
Chile
Status:
Recruiting
Facility:
Name:
Hopital Robert Schuman
Address:
City:
Vantoux
Zip:
57070
Country:
France
Status:
Recruiting
Facility:
Name:
Azienda Ospedaliera Santa Maria Terni
Address:
City:
Terni
Zip:
05100
Country:
Italy
Status:
Recruiting
Facility:
Name:
Chungbuk National University Hospital
Address:
City:
Cheongju-si
Zip:
28644
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Jeonbuk National University Hospital
Address:
City:
Jeonju-si
Zip:
54907
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Specjalistyczne Gabinety Sp. z o.o
Address:
City:
Krakow
Zip:
30-539
Country:
Poland
Status:
Recruiting
Facility:
Name:
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu
Address:
City:
Przemysl
Zip:
37-700
Country:
Poland
Status:
Recruiting
Facility:
Name:
Institutul Oncologic Prof. Dr. Ion Chiricuta
Address:
City:
Cluj-Napoca
Zip:
400015
Country:
Romania
Status:
Recruiting
Facility:
Name:
S.C. Medisprof S.R.L
Address:
City:
Cluj-Napoca
Zip:
400641
Country:
Romania
Status:
Recruiting
Facility:
Name:
Clincial Centre of Serbia
Address:
City:
Belgrade
Zip:
11000
Country:
Serbia
Status:
Recruiting
Facility:
Name:
Hospital General Universitario de Elche
Address:
City:
Alicante
Zip:
03203
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitari Quiron Dexeus Barcelona
Address:
City:
Barcelona
Zip:
08028
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Fundacion Jimenez Diaz
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Fundacion Alcorcon
Address:
City:
Madrid
Zip:
28922
Country:
Spain
Status:
Recruiting
Facility:
Name:
Complejo Hospitalario Universitario de Ourense
Address:
City:
Ourense
Zip:
32005
Country:
Spain
Status:
Recruiting
Facility:
Name:
Complejo Hospitalario Universitario De Santiago De Compostela
Address:
City:
Santiago de Compostela
Zip:
15706
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Virgen del Rocio
Address:
City:
Seville
Zip:
41013
Country:
Spain
Status:
Recruiting
Facility:
Name:
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulev
Address:
City:
Valencia
Zip:
46026
Country:
Spain
Status:
Recruiting
Start date:
September 12, 2024
Completion date:
October 28, 2026
Lead sponsor:
Agency:
Amgen
Agency class:
Industry
Source:
Amgen
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06430866
http://www.amgentrials.com
