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)

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 726 (estimated)
• Sponsor: mAbxience Research S.L. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non Squamous Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	MB12 (Proposed Pembrolizumab Biosimilar)	200mg IV, every 3 weeks on Day 1
DRUG	EU-sourced Keytruda®	200mg IV, every 3 weeks on Day 1
DRUG	US-sourced Keytruda®	200mg IV, every 3 weeks on Day 1
DRUG	Pemetrexed	500 mg/m2 IV, every 3 weeks on Day 1
DRUG	Carboplatin	Area under the curve (AUC) 5 IV, every 3 weeks on Day 1 for 4 cycles.
DRUG	Cisplatin	75 mg/m2 IV, every 3 weeks on Day 1 for 4 cycles

Timeline

• Start date: 2024-12-30
• Primary completion: 2026-06-01
• Completion: 2027-09-01
• First posted: 2024-11-13
• Last updated: 2026-03-11

Locations

151 sites across 23 countries: Armenia, Bosnia and Herzegovina, Georgia, Greece, Italy, Japan, Jordan, Malaysia, Moldova, Panama, Philippines, Poland, Portugal, Romania, Serbia, Slovakia, South Africa, South Korea, Spain, Taiwan, Thailand, Tunisia, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study