pharmacokinetic similarity between abp 234 and keytruda® (pembrolizumab)

Conditions: Early-stage Non-squamous Non-small Cell Lung Cancer (NSCLC)

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.

Keywords: nsclc keytruda pembrolizumab abp 234