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)
mAbxience Research S.L.
726 participants
Dec 30, 2024
INTERVENTIONAL
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.
Eligibility
Plain Language Summary
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Interventions
200mg IV, every 3 weeks on Day 1
200mg IV, every 3 weeks on Day 1
200mg IV, every 3 weeks on Day 1
500 mg/m2 IV, every 3 weeks on Day 1
Area under the curve (AUC) 5 IV, every 3 weeks on Day 1 for 4 cycles.
75 mg/m2 IV, every 3 weeks on Day 1 for 4 cycles
Locations(151)
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NCT06687369