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Study identifier: NCT06687369 Synced from ClinicalTrials.gov · August 07, 2026
● Study status: Recruiting

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

Condition: Non Squamous Non Small Cell Lung Cancer  ·  Sponsor: mAbxience Research S.L.

PhasePhase 3
Planned participants726
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Susana Millán, PhD  ·  +34917711500  ·  Susana.Millan@mabxience.com

Camino Huerga  ·  +34917711500  ·  Camino.Huerga@mabxience.com

Always discuss trial participation with your own doctor first.

Locations (151)

Site 101001Yerevan, ArmeniaRecruiting
Site 101002Yerevan, ArmeniaRecruiting
Site 101003Yerevan, ArmeniaRecruiting
Site 101004Yerevan, ArmeniaRecruiting
Site 103001Sarajevo, Bosnia and HerzegovinaRecruiting
Site 103002Tuzla, Bosnia and HerzegovinaRecruiting
Site 103003Zenica, Bosnia and HerzegovinaRecruiting
Site 108004Batumi, GeorgiaRecruiting
Site 108005Kutaisi, GeorgiaRecruiting
Site 108011Marneuli, GeorgiaRecruiting
Site 108001Tbilisi, GeorgiaRecruiting
Site 108002Tbilisi, GeorgiaRecruiting

+ 139 more locations — full list on the registry record.

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This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.

Source record: clinicaltrials.gov/study/NCT06687369