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
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
The primary objective of this study is to demonstrate pharmacokinetic (PK) similarity ABP 234 with pembrolizumab.
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:
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:
Providencia, Region Metropolotana 7500859, Chile
Providencia, Santiago Metropolitan 7500921, Chile
Region Metropolitana, Santiago Metropolitan 7560908, Chile
Viña Del Mar, Valparaiso 2540364, Chile
Viña del Mar, Valparaiso 2520598, Chile
Toulon, 83056, France
Essen, 45276, Germany
Monserrato, 09042, Italy
Cheras, Kuala Lumpur 56000, Malaysia
León, Guanajuato 37178, Mexico
Zapopan, Jalisco 45070, Mexico
Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-796, Poland
Olsztyn, Warmian-Masurian Voivodeship 10-357, Poland
Jud. Iasi, 700106, Romania
Seoul, 07061, South Korea
A Coruna Galicia, 15009, Spain
Madrid, 28050, Spain
Málaga, 29004, Spain
Valencia, 46026, Spain
Kaohsiung County, 83301, Taiwan
Bangkoknoi, Bangkok 10700, Thailand
Pathumwan, Bangkok 10330, Thailand
Muang, Changwat Lampang 52000, Thailand
Muang, Changwat Phitsanulok 65000, Thailand
Muang, Chiang Mai 52000, Thailand
Ankara, 06200, Turkey (Türkiye)