A Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) to Keytruda® in Non-small Cell Lung Cancer (BENITO Study)
March 10, 2026 updated by: mAbxience Research S.L.
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)
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
726
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Susana Millán, PhD
- Phone Number: +34917711500
- Email: Susana.Millan@mabxience.com
Study Contact Backup
- Name: Camino Huerga
- Phone Number: +34917711500
- Email: Camino.Huerga@mabxience.com
Study Locations
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Yerevan, Armenia
- Recruiting
- Site 101001
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Yerevan, Armenia
- Recruiting
- Site 101002
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Yerevan, Armenia
- Recruiting
- Site 101003
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Yerevan, Armenia
- Recruiting
- Site 101004
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Sarajevo, Bosnia and Herzegovina
- Recruiting
- Site 103001
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Tuzla, Bosnia and Herzegovina
- Recruiting
- Site 103002
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Zenica, Bosnia and Herzegovina
- Recruiting
- Site 103003
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Batumi, Georgia
- Recruiting
- Site 108004
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Kutaisi, Georgia
- Recruiting
- Site 108005
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Marneuli, Georgia
- Recruiting
- Site 108011
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Tbilisi, Georgia
- Recruiting
- Site 108002
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Tbilisi, Georgia
- Recruiting
- Site 108006
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Tbilisi, Georgia
- Recruiting
- Site 108007
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Tbilisi, Georgia
- Recruiting
- Site 108009
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Tbilisi, Georgia
- Recruiting
- Site 108003
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Tbilisi, Georgia
- Recruiting
- Site 108001
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Tbilisi, Georgia
- Recruiting
- Site 108008
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Tbilisi, Georgia
- Recruiting
- Site 108010
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Tbilisi, Georgia
- Recruiting
- Site 108012
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Athens, Greece
- Recruiting
- Site 110006
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Kifissia, Greece
- Recruiting
- Site 110003
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Larissa, Greece
- Recruiting
- Site 110004
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Pátrai, Greece
- Recruiting
- Site 110009
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Thessaloniki, Greece
- Recruiting
- Site 110001
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Thessaloniki, Greece
- Recruiting
- Site 110002
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Thessaloniki, Greece
- Recruiting
- Site 110005
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Thessaloniki, Greece
- Recruiting
- Site 110008
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Volos, Greece
- Recruiting
- Site 110010
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Brescia, Italy
- Recruiting
- Site 113012
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Cremona, Italy
- Recruiting
- Site 113010
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Genova, Italy
- Recruiting
- Site 113007
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Lecce, Italy
- Recruiting
- Site 113011
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Meldola, Italy
- Recruiting
- Site 113009
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Pavia, Italy
- Recruiting
- Site 113001
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Roma, Italy
- Recruiting
- Site 113003
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Roma, Italy
- Recruiting
- Site 113006
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Siena, Italy
- Recruiting
- Site 113005
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Torino, Italy
- Recruiting
- Site 113008
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Hakodate-shi, Japan
- Recruiting
- Site 207002
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Okayama, Japan
- Recruiting
- Site 207012
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Shinagawa-Ku, Japan
- Recruiting
- Site 207010
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Shizuoka, Japan
- Recruiting
- Site 207001
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Amman, Jordan
- Recruiting
- Site 114001
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Amman, Jordan
- Recruiting
- Site 114002
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Amman, Jordan
- Recruiting
- Site 114003
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Amman, Jordan
- Recruiting
- Site 114004
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Amman, Jordan
- Recruiting
- Site 114005
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Amman, Jordan
- Recruiting
- Site 114007
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Irbid, Jordan
- Recruiting
- Site 114006
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Cheras, Malaysia
- Recruiting
- Site 202001
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Kota Bharu, Malaysia
- Recruiting
- Site 202002
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Kuala Selangor, Malaysia
- Recruiting
- Site 202003
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Chisinau, Moldova
- Recruiting
- Research site 116001
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Panama City, Panama
- Recruiting
- Site 304001
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Panama City, Panama
- Recruiting
- Site 304002
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Panama City, Panama
- Recruiting
- Site 304003
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Bacolod City, Philippines
- Recruiting
- Site 203006
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Baguio City, Philippines
- Recruiting
- Site 203003
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Iloilo City, Philippines
- Recruiting
- Site 203004
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Iloilo City, Philippines
- Recruiting
- Site 203009
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Makati City, Philippines
- Recruiting
- Site 203005
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Manila, Philippines
- Recruiting
- Site 203007
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Quezon City, Philippines
- Recruiting
- Site 203002
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Katowice, Poland
- Recruiting
- Site 118004
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Lodz, Poland
- Recruiting
- Site 118001
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Lublin, Poland
- Recruiting
- Site 118005
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Prabuty, Poland
- Recruiting
- Site 118002
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Słupsk, Poland
- Recruiting
- Site 118003
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Lisbon, Portugal
- Recruiting
- Site 119001
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Matosinhos Municipality, Portugal
- Recruiting
- Site 119002
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Porto, Portugal
- Recruiting
- Site 119003
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Cluj-Napoca, Romania
- Recruiting
- Site 120001
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Craiova, Romania
- Recruiting
- Site 120003
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Craiova, Romania
- Recruiting
- Site 120004
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Floreşti, Romania
- Recruiting
- Site 120006
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Timișoara, Romania
- Recruiting
- Site 120005
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Belgrade, Serbia
- Recruiting
- Site 121001
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Belgrade, Serbia
- Recruiting
- Site 121002
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Kamenitz, Serbia
- Recruiting
- Site 121004
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Kragujevac, Serbia
- Recruiting
- Site 121003
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Užice, Serbia
- Recruiting
- Site 121005
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Bardejov, Slovakia
- Recruiting
- Site 122003
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Bratislava, Slovakia
- Recruiting
- Site 122001
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Partizánske, Slovakia
- Recruiting
- Site 122002
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Johannesburg, South Africa
- Recruiting
- Site 123005
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Johannesburg, South Africa
- Recruiting
- Site 123006
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Kraaifontein, South Africa
- Recruiting
- Site 123007
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KwaZulu, South Africa
- Recruiting
- Site 123004
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Port Elizabeth, South Africa
- Recruiting
- Site 123002
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Pretoria, South Africa
- Recruiting
- Site 123001
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Pretoria, South Africa
- Recruiting
- Site 123003
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Busan, South Korea
- Recruiting
- Site 204005
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Gyeonggi-do, South Korea
- Recruiting
- Site 204004
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Gyeonggi-do, South Korea
- Recruiting
- Site 204006
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Incheon, South Korea
- Recruiting
- Site 204001
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Seoul, South Korea
- Recruiting
- Site 204002
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Seoul, South Korea
- Recruiting
- Site 204007
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A Coruña, Spain
- Recruiting
- Site 124006
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Barcelona, Spain
- Recruiting
- Site 124013
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Barcelona, Spain
- Recruiting
- Site 124002
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Madrid, Spain
- Recruiting
- Site 124011
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Madrid, Spain
- Recruiting
- Site 124012
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Madrid, Spain
- Recruiting
- Site 124007
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Madrid, Spain
- Recruiting
- Site 124009
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Murcia, Spain
- Recruiting
- Site 124016
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Málaga, Spain
- Recruiting
- Site 124008
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Oviedo, Spain
- Recruiting
- Site 124003
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Palma de Mallorca, Spain
- Recruiting
- Site 124001
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Pontevedra, Spain
- Recruiting
- Site 124014
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Sant Joan Despí, Spain
- Recruiting
- Site 124005
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Santiago de Compostela, Spain
- Recruiting
- Site 124010
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Seville, Spain
- Recruiting
- Site 124004
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Valencia, Spain
- Recruiting
- Site 124015
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Kaohsiung City, Taiwan
- Recruiting
- Site 205003
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Kaohsiung City, Taiwan
- Recruiting
- Site 205009
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Liuying, Taiwan
- Recruiting
- Site 205004
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Taichung, Taiwan
- Recruiting
- Site 205002
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Taichung, Taiwan
- Recruiting
- Site 205008
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Tainan, Taiwan
- Recruiting
- Site 205005
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Taipei, Taiwan
- Recruiting
- Site 205006
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Taipei, Taiwan
- Recruiting
- Site 205007
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Bangkok, Thailand
- Recruiting
- Site 206004
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Bangkok, Thailand
- Recruiting
- Site 206005
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Chiang Mai, Thailand
- Recruiting
- Site 206001
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Chiang Rai, Thailand
- Recruiting
- Site 206007
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Khon Kaen, Thailand
- Recruiting
- Site 206003
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Nakhon Nayok, Thailand
- Recruiting
- Site 206002
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Songkhla, Thailand
- Recruiting
- Site 206006
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Aryanah, Tunisia
- Recruiting
- Site 112002
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Aryanah, Tunisia
- Recruiting
- Site 112003
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Aryanah, Tunisia
- Recruiting
- Site 112004
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Sfax, Tunisia
- Recruiting
- Site 112001
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Tunis, Tunisia
- Recruiting
- Site 112005
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Adana, Turkey (Türkiye)
- Recruiting
- Site 125017
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Alanya, Turkey (Türkiye)
- Recruiting
- Site 125006
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Ankara, Turkey (Türkiye)
- Recruiting
- Site 125001
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Ankara, Turkey (Türkiye)
- Recruiting
- Site 125002
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Ankara, Turkey (Türkiye)
- Recruiting
- Site 125004
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Ankara, Turkey (Türkiye)
- Recruiting
- Site 125008
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Ankara, Turkey (Türkiye)
- Recruiting
- Site 125009
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Ankara, Turkey (Türkiye)
- Recruiting
- Site 125019
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Istanbul, Turkey (Türkiye)
- Recruiting
- Site 125003
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Istanbul, Turkey (Türkiye)
- Recruiting
- Site 125010
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Istanbul, Turkey (Türkiye)
- Recruiting
- Site 125011
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Istanbul, Turkey (Türkiye)
- Recruiting
- Site 125012
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Istanbul, Turkey (Türkiye)
- Recruiting
- Site 125018
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Izmir, Turkey (Türkiye)
- Recruiting
- Site 125015
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Sakarya, Turkey (Türkiye)
- Recruiting
- Site 125023
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Samsun, Turkey (Türkiye)
- Recruiting
- Site 125013
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Tekirdağ, Turkey (Türkiye)
- Recruiting
- Site 125007
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Yüreğir, Turkey (Türkiye)
- Recruiting
- Site 125014
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Adult male/female patients ≥18 years old at the time of signing the informed consent form (ICF).
- Histologic or cytologic diagnosis of advanced NSCLC, stage IV (defined by the 8th edition of the Tumor Node Metastasis [TNM] classification), with no EGFR sensitizing (activating) mutation or ALK translocation, and who have not received prior systemic treatment for metastatic NSCLC. In those patients in whom the pleural or pericardial effusion is the only location of metastatic disease, confirmation of its malignant etiology is required.
- At least 1 radiographically measurable lesion according to response evaluation criteria in solid tumors (RECIST) 1.1.
- Known status of PD-L1 expression.
- Performance based on the Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
- Adequate hepatic, renal, hematologic, endocrine, and coagulation function.
Exclusion Criteria:
- Predominantly squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the patient is not eligible.
- Known history of central nervous system metastases and/or carcinomatous meningitis.
- Prior anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T lymphocyte associated protein (CTLA)-4 therapy (including ipilimumab or any other antibody or drug that specifically targets co-stimulation of T-cells or immune checkpoints).
- Major surgery within 3 weeks of the first dose of study treatment.
- Active autoimmune disease that has required systemic treatment in the last 2 years.
- Contraindication and/or intolerance to the administration of pembrolizumab or known sensitivity to any component of pembrolizumab.
- Has a known sensitivity to any component of cisplatin, carboplatin, or pemetrexed.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MB12 (Proposed Pembrolizumab Biosimilar)
MB12 (Proposed Pembrolizumab Biosimilar) + Pemetrexed + Carboplatin/ Cisplatin
|
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
|
|
Active Comparator: EU- sourced Keytruda®
EU- sourced Keytruda® + Pemetrexed + Carboplatin/ Cisplatin
|
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
200mg IV, every 3 weeks on Day 1
|
|
Active Comparator: US- sourced Keytruda®
US- sourced Keytruda® + Pemetrexed + Carboplatin/ Cisplatin
|
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
200mg IV, every 3 weeks on Day 1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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Area under the concentration-time curve (AUC) between Cycle 1 and Cycle 2 (AUC from time 0 to 504 hours postdose [AUC0-504].
AUC at steady state (AUCss) between Cycle 7 and Cycle 8.
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Week 1 - Week 24
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To demonstrate the efficacy equivalence of MB12 and Keytruda® in combination with chemotherapy administered as first-line treatment in patients with advanced/metastatic non-squamous NSCLC (any PD-L1 expression type).
Time Frame: Week 1 - Week 24
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Objective response rate (ORR), up to and including 24 weeks (end of Cycle 8)
|
Week 1 - Week 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To assess the efficacy of MB12 as compared with Keytruda® based on other efficacy parameters and timepoints over the study period.
Time Frame: Week 1 - Week 52
|
Objective response rate (ORR), Progression-free survival (PFS), Duration of response (DOR) and Overall survival (OS)
|
Week 1 - Week 52
|
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To compare the PK profile based on other PK parameters and timepoints (not covered by the primary PK endpoints) of MB12 as compared with Keytruda® over the study period.
Time Frame: Week 1 - Week 52
|
Maximum concentration (Cmax), Time to maximum concentration (Tmax), Minimum concentration (Ctrough), Clearance (CL), Elimination half-life (t1/2), Distribution volume (Vd)
|
Week 1 - Week 52
|
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To assess the safety and tolerability of MB12 as compared with Keytruda®
Time Frame: Week 1 - Week 52
|
Treatment-emergent adverse events (TEAEs)
|
Week 1 - Week 52
|
|
To assess the immunogenicity of MB12 as compared with Keytruda®
Time Frame: Week 1 - Week 52
|
Anti-drug antibodies (ADAs) and Neutralizing antibodies (NAbs) in ADA-positive samples
|
Week 1 - Week 52
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 30, 2024
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
September 1, 2027
Study Registration Dates
First Submitted
November 11, 2024
First Submitted That Met QC Criteria
November 12, 2024
First Posted (Actual)
November 13, 2024
Study Record Updates
Last Update Posted (Actual)
March 11, 2026
Last Update Submitted That Met QC Criteria
March 10, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Respiratory Tract Diseases
- Lung Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Amino Acids, Peptides, and Proteins
- Organic Chemicals
- Heterocyclic Compounds
- Heterocyclic Compounds, 2-Ring
- Heterocyclic Compounds, Fused-Ring
- Inorganic Chemicals
- Chlorine Compounds
- Nitrogen Compounds
- Coordination Complexes
- Guanine
- Hypoxanthines
- Purinones
- Purines
- Glutamates
- Amino Acids, Acidic
- Amino Acids
- Amino Acids, Dicarboxylic
- Platinum Compounds
- Pemetrexed
- Carboplatin
- Cisplatin
Other Study ID Numbers
- MB12-C-02-24
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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