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

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06430866Tipo: INTERVENTIONALInicio: 12 de sept de 2024Fin estimado: 14 de dic de 2026

Oncología Neumología

Traducción no disponible, mostrando original

Resumen

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

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 99 YearsSexo: ALL

Criterios de inclusión

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.
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).

Criterios de exclusión

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.

Intervenciones

drug

ABP 234

Administered by intravenous (IV) injection.

drug

Pembrolizumab

Administered by IV injection.

Ubicaciones

Fundacion ARS Medica

San Salvador de Jujuy, Jujuy Province, Argentina

RECRUITING

Instituto de Oncologia de Rosario

Rosario, Santa Fe Province, Argentina

RECRUITING

Ionc Instituto Oncologico De Cordoba

Córdoba, Argentina

RECRUITING

Patrocinadores

PrincipalAmgen

Contactos

Amgen Call Center

CONTACT

medinfo@amgen.com 866-572-6436

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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