Clinical Trials in Italy / NCT06430866
Active, not recruiting
Phase 3
Pharmacokinetic Similarity Between ABP 234 and Keytruda® (Pembrolizumab)
NCT06430866 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Early-stage Non-squamous Non-small Cell Lung Cancer (NSCLC)
Investigational drug(s) / intervention(s)
ABP 234: Administered by intravenous (IV) injection.
Pembrolizumab: Administered by IV injection.
Study summary
The primary objective of this study is to demonstrate pharmacokinetic (PK) similarity ABP 234 with pembrolizumab.
Eligibility
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.
Primary outcome measure(s)
- 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
Trial sites (128)
| Facility | City | Region | Status |
|---|---|---|---|
| Fundacion ARS Medica | San Salvador de Jujuy | Jujuy Province | |
| Instituto de Oncologia de Rosario | Rosario | Santa Fe Province | |
| Ionc Instituto Oncologico De Cordoba | Córdoba | Argentina | |
| University Multiprofile Hospital for Active Treatment Sofiamed | Sofia | Bulgaria | |
| CDIEM - Centro de Investigacion y Especialidades Medicas | Providencia | Region Metropolotana | |
| Instituto Oncologico Fundacion Arturo Lopez Perez (FALP) | Providencia | Santiago Metropolitan | |
| Centro de Oncologia de Precision | Region Metropolitana | Santiago Metropolitan | |
| Clinica Santa Maria | Santiago | Santiago Metropolitan | |
| Centro de Investigaciones Clinicas Vina del Mar Ltda. | Viña Del Mar | Valparaiso | |
| Centro de Investigacin de Enfermedades Respiratorias e Inmunologicas Limitada CIERI | Viña del Mar | Valparaiso | |
| K2 Oncology | Santiago | 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 Ospedaliero - Universitaria di Ferrara | Cona | Italy | |
| Azienda Ospedaliera S. Croce e Carle | Cuneo | Italy | |
| Azienda Ospedaliero-Universitaria Careggi | Florence | Italy | |
| Ospedale Versilia | Lucca | Italy | |
| Azienda USL 2 Lucca | Lucca | Italy | |
| AOU Cagliari-Policlinico Universitario Duilio Casula di Monserrato-UOC Oncologia Medica | Monserrato | Italy | |
| ASL Napoli 1 Centro-Ospedale del Mare | Naples | Italy | |
| Casa Di Cura Polispecialistica Dott Pederzoli | Peschiera del Garda | Italy | |
| AUSL Della Romagna - Ospedale S.Maria delle Croci | Ravenna | Italy | |
| IRCCS Istituto clinico humanitas - Humanitas Mirasole spa | Rozzano | Italy | |
| Azienda Ospedaliera Santa Maria Terni | Terni | Italy | |
| ASST Sette Laghi | Varese | Italy | |
| Raja Perempuan Zainab II Hospital | Kota Bharu | Kelantan | |
| Hospital Canselor Tuanku Muhriz UKM | Cheras | Kuala Lumpur | |
| Hospital Umum Sarawak | Kuching | Sarawak | |
| Preparaciones Oncolgicas S.C. | León | Guanajuato | |
| Investigacion Biomedica para el Desarrollo de Nuevos Farmacos SA de CV | Zapopan | Jalisco |
+ 88 more sites — see the full list on the official registry below.
On this site
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06430866 on ClinicalTrials.gov ↗ ← All trials in Italy