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

Source: https://onco.cc/trials/nct06687369/  
OnCo record `nct06687369` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of Pemetrexed, Carboplatin, Cisplatin in non-small-cell lung cancer and small-cell lung cancer, run by mAbxience Research S.L., active and no longer recruiting.

## Summary

A Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) to Keytruda® in Non-small Cell Lung Cancer (BENITO Study) is a phase 3 interventional study registered as NCT06687369 by mAbxience Research S.L., with 726 participants planned, started 2024-12-30 and due to reach its primary completion in 2026-08-31. Interventions recorded: MB12 (Proposed Pembrolizumab Biosimilar), EU-sourced Keytruda®, US-sourced Keytruda®, Pemetrexed, Carboplatin. Conditions listed: Non Squamous Non Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-16
- Tags: ctgov-ingest
- Registry id: NCT06687369
- Phase: 3
- Setting: 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)
- Sponsor: mAbxience Research S.L.
- Enrolled: 726

## Sources

- ClinicalTrials.gov NCT06687369: https://clinicaltrials.gov/study/NCT06687369

## Connected records

- cancers: [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [Small-cell lung cancer](https://onco.cc/cancers/sclc/)
- drugs: [Carboplatin](https://onco.cc/drugs/carboplatin/), [Cisplatin](https://onco.cc/drugs/cisplatin/), [Pemetrexed](https://onco.cc/drugs/pemetrexed/)
- companies: [mAbxience Research S.L.](https://onco.cc/companies/mabxience-research-s-l/)

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