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

NCT06687369 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 726

Last updated 2026-03-11

No results posted yet for this study

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

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

Sponsors & Collaborators

  • mAbxience Research S.L.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-30
Primary Completion
2026-06-30
Completion
2027-09-30
FDA Drug
Yes

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)

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06687369 on ClinicalTrials.gov