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

• Status: RECRUITING
• Trial end date: 2027-09-01

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.

• Phase: PHASE3

Details

• Lead Sponsor: mAbxience Research S.L.
• Treatments: Carboplatin; Cisplatin; Pemetrexed