Last updated 4 days ago
Pharmacokinetic Similarity Between ABP 234 and Keytruda® (Pembrolizumab)
154 patients around the world
Available in Chile
Amgen
2Research sites
154Patients around the world
This study is for people with
Lung cancer
Non-small cell lung carcinoma
Requirements for the patient
To 99 Years
All Gender
Medical requirements
- 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).
- 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.
Sites
Centro de Investigaciones Clínicas Viña Del Mar
Recruiting
Centro Oncológico y Tratamiento Oncología - CDIEM
Recruiting
StudyEucalyptus
SponsorAmgen
Conditions
Non-small cell lung carcinoma
Requirements
To 99 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06430866
