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

Sponsor
mAbxience Research S.L.
Study ID
NCT06687369
Phase
PHASE3
Status
Recruiting
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Conditions

  • Non Squamous Non Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 30, 2024
Status verified
Mar 2026
Primary completion
Jun 30, 2026
Completion
Sep 30, 2027

Study Design

Enrollment
726 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MB12 (Proposed Pembrolizumab Biosimilar)
    MB12 (Proposed Pembrolizumab Biosimilar) + Pemetrexed + Carboplatin/ Cisplatin
  • Active Comparator: EU- sourced Keytruda®
    EU- sourced Keytruda® + Pemetrexed + Carboplatin/ Cisplatin
  • Active Comparator: US- sourced Keytruda®
    US- sourced Keytruda® + Pemetrexed + Carboplatin/ Cisplatin

Primary Outcome Measure

To demonstrate the pharmacokinetic (PK) bioequivalence of MB12, EU-sourced Keytruda® and US-sourced Keytruda® in combination with chemotherapy [ Time Frame: Week 1 - Week 24 ]

Central Contacts

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