Clinical Trial

A Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) to Keytruda® in Non-small Cell Lung Cancer (BENITO Study)

Recruiting Phase 3
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Record status
This record was last updated March 11, 2026 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2024-11-12; most recent amendment 2026-03-10.
Status change: Not Yet Recruiting → Recruiting 2025-02-03
Trial Details
NCT Number NCT06687369
Lead Sponsor mAbxience Research S.L.
Conditions Non Squamous Non Small Cell Lung Cancer
Enrollment 726 participants
Start Date 2024-12-30
Primary Completion 2026-06 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2026-03-11