clinical trial · NCT06687369
A Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) to Keytruda® in Non-small Cell Lung Cancer (BENITO Study)
mAbxience Research S.L.·phase3·recruiting·n = 726
Non Squamous Non Small Cell Lung CancerMB12 (Proposed Pembrolizumab Biosimilar)EU-sourced Keytruda®US-sourced Keytruda®PemetrexedCarboplatinCisplatin
brief summary
This is a randomized, multicenter, multinational, double-blind, integrated pharmacokinetics (PK) and efficacy similarity study to compare the PK, efficacy, safety, and immunogenicity of MB12 versus Keytruda® in combination with pemetrexed-platinum chemotherapy as first-line treatment in patients with metastatic non-squamous NSCLC.
started
Dec 30, 2024
primary completion
Jun 1, 2026
completion
Sep 1, 2027
last updated
Mar 11, 2026
official title
Randomized, Multicenter, Multinational, Double-Blind Study to Compare the Pharmacokinetics, Efficacy, Safety and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) Versus Keytruda® in Combination With Chemotherapy for the Treatment of Patients With Advanced Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (BENITO Study)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol