A Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) to Keytruda® in Non-small Cell Lung Cancer (BENITO Study)
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)
1 other identifier
interventional
726
22 countries
146
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2024
Typical duration for phase_3
146 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 11, 2024
CompletedFirst Posted
Study publicly available on registry
November 13, 2024
CompletedStudy Start
First participant enrolled
December 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
March 11, 2026
March 1, 2026
1.4 years
November 11, 2024
March 10, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
To demonstrate the pharmacokinetic (PK) bioequivalence of MB12, EU-sourced Keytruda® and US-sourced Keytruda® in combination with chemotherapy
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.
Week 1 - Week 24
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).
Objective response rate (ORR), up to and including 24 weeks (end of Cycle 8)
Week 1 - Week 24
Secondary Outcomes (4)
To assess the efficacy of MB12 as compared with Keytruda® based on other efficacy parameters and timepoints over the study period.
Week 1 - Week 52
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.
Week 1 - Week 52
To assess the safety and tolerability of MB12 as compared with Keytruda®
Week 1 - Week 52
To assess the immunogenicity of MB12 as compared with Keytruda®
Week 1 - Week 52
Study Arms (3)
MB12 (Proposed Pembrolizumab Biosimilar)
EXPERIMENTALMB12 (Proposed Pembrolizumab Biosimilar) + Pemetrexed + Carboplatin/ Cisplatin
EU- sourced Keytruda®
ACTIVE COMPARATOREU- sourced Keytruda® + Pemetrexed + Carboplatin/ Cisplatin
US- sourced Keytruda®
ACTIVE COMPARATORUS- sourced Keytruda® + Pemetrexed + Carboplatin/ Cisplatin
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (151)
Site 101001
Yerevan, Armenia
Site 101002
Yerevan, Armenia
Site 101003
Yerevan, Armenia
Site 101004
Yerevan, Armenia
Site 103001
Sarajevo, Bosnia and Herzegovina
Site 103002
Tuzla, Bosnia and Herzegovina
Site 103003
Zenica, Bosnia and Herzegovina
Site 108004
Batumi, Georgia
Site 108005
Kutaisi, Georgia
Site 108011
Marneuli, Georgia
Site 108001
Tbilisi, Georgia
Site 108002
Tbilisi, Georgia
Site 108003
Tbilisi, Georgia
Site 108006
Tbilisi, Georgia
Site 108007
Tbilisi, Georgia
Site 108008
Tbilisi, Georgia
Site 108009
Tbilisi, Georgia
Site 108010
Tbilisi, Georgia
Site 108012
Tbilisi, Georgia
Site 110006
Athens, Greece
Site 110003
Kifissia, Greece
Site 110004
Larissa, Greece
Site 110009
Pátrai, Greece
Site 110001
Thessaloniki, Greece
Site 110002
Thessaloniki, Greece
Site 110005
Thessaloniki, Greece
Site 110008
Thessaloniki, Greece
Site 110010
Volos, Greece
Site 113012
Brescia, Italy
Site 113010
Cremona, Italy
Site 113007
Genova, Italy
Site 113011
Lecce, Italy
Site 113009
Meldola, Italy
Site 113001
Pavia, Italy
Site 113003
Roma, Italy
Site 113006
Roma, Italy
Site 113005
Siena, Italy
Site 113008
Torino, Italy
Site 207002
Hakodate-shi, Japan
Site 207012
Okayama, Japan
Site 207010
Shinagawa-Ku, Japan
Site 207001
Shizuoka, Japan
Site 114001
Amman, Jordan
Site 114002
Amman, Jordan
Site 114003
Amman, Jordan
Site 114004
Amman, Jordan
Site 114005
Amman, Jordan
Site 114007
Amman, Jordan
Site 114006
Irbid, Jordan
Site 202001
Cheras, Malaysia
Site 202002
Kota Bharu, Malaysia
Site 202003
Kuala Selangor, Malaysia
Research site 116001
Chisinau, Moldova
Site 304001
Panama City, Panama
Site 304002
Panama City, Panama
Site 304003
Panama City, Panama
Site 203006
Bacolod City, Philippines
Site 203003
Baguio City, Philippines
Site 203004
Iloilo City, Philippines
Site 203009
Iloilo City, Philippines
Site 203005
Makati City, Philippines
Site 203007
Manila, Philippines
Site 203002
Quezon City, Philippines
Site 118004
Katowice, Poland
Site 118001
Lodz, Poland
Site 118005
Lublin, Poland
Site 118002
Prabuty, Poland
Site 118003
Słupsk, Poland
Site 119001
Lisbon, Portugal
Site 119002
Matosinhos Municipality, Portugal
Site 119003
Porto, Portugal
Site 120001
Cluj-Napoca, Romania
Site 120003
Craiova, Romania
Site 120004
Craiova, Romania
Site 120006
Floreşti, Romania
Site 120005
Timișoara, Romania
Site 121001
Belgrade, Serbia
Site 121002
Belgrade, Serbia
Site 121004
Kamenitz, Serbia
Site 121003
Kragujevac, Serbia
Site 121005
Užice, Serbia
Site 122003
Bardejov, Slovakia
Site 122001
Bratislava, Slovakia
Site 122002
Partizánske, Slovakia
Site 123005
Johannesburg, South Africa
Site 123006
Johannesburg, South Africa
Site 123007
Kraaifontein, South Africa
Site 123004
KwaZulu, South Africa
Site 123002
Port Elizabeth, South Africa
Site 123001
Pretoria, South Africa
Site 123003
Pretoria, South Africa
Site 204005
Busan, South Korea
Site 204004
Gyeonggi-do, South Korea
Site 204006
Gyeonggi-do, South Korea
Site 204001
Incheon, South Korea
Site 204002
Seoul, South Korea
Site 204007
Seoul, South Korea
Site 124006
A Coruña, Spain
Site 124002
Barcelona, Spain
Site 124013
Barcelona, Spain
Site 124007
Madrid, Spain
Site 124009
Madrid, Spain
Site 124011
Madrid, Spain
Site 124012
Madrid, Spain
Site 124008
Málaga, Spain
Site 124016
Murcia, Spain
Site 124003
Oviedo, Spain
Site 124001
Palma de Mallorca, Spain
Site 124014
Pontevedra, Spain
Site 124005
Sant Joan Despí, Spain
Site 124010
Santiago de Compostela, Spain
Site 124004
Seville, Spain
Site 124015
Valencia, Spain
Site 205003
Kaohsiung City, Taiwan
Site 205009
Kaohsiung City, Taiwan
Site 205004
Liuying, Taiwan
Site 205002
Taichung, Taiwan
Site 205008
Taichung, Taiwan
Site 205005
Tainan, Taiwan
Site 205006
Taipei, Taiwan
Site 205007
Taipei, Taiwan
Site 206004
Bangkok, Thailand
Site 206005
Bangkok, Thailand
Site 206001
Chiang Mai, Thailand
Site 206007
Chiang Rai, Thailand
Site 206003
Khon Kaen, Thailand
Site 206002
Nakhon Nayok, Thailand
Site 206006
Songkhla, Thailand
Site 112002
Aryanah, Tunisia
Site 112003
Aryanah, Tunisia
Site 112004
Aryanah, Tunisia
Site 112001
Sfax, Tunisia
Site 112005
Tunis, Tunisia
Site 125017
Adana, Turkey (Türkiye)
Site 125006
Alanya, Turkey (Türkiye)
Site 125001
Ankara, Turkey (Türkiye)
Site 125002
Ankara, Turkey (Türkiye)
Site 125004
Ankara, Turkey (Türkiye)
Site 125008
Ankara, Turkey (Türkiye)
Site 125009
Ankara, Turkey (Türkiye)
Site 125019
Ankara, Turkey (Türkiye)
Site 125003
Istanbul, Turkey (Türkiye)
Site 125010
Istanbul, Turkey (Türkiye)
Site 125011
Istanbul, Turkey (Türkiye)
Site 125012
Istanbul, Turkey (Türkiye)
Site 125018
Istanbul, Turkey (Türkiye)
Site 125015
Izmir, Turkey (Türkiye)
Site 125023
Sakarya, Turkey (Türkiye)
Site 125013
Samsun, Turkey (Türkiye)
Site 125007
Tekirdağ, Turkey (Türkiye)
Site 125014
Yüreğir, Turkey (Türkiye)
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2024
First Posted
November 13, 2024
Study Start
December 30, 2024
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
September 1, 2027
Last Updated
March 11, 2026
Record last verified: 2026-03