A Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) to Keytruda® in Non-small Cell Lung Cancer (BENITO Study)
NCT ID: NCT06687369
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
726 participants
INTERVENTIONAL
2024-12-30
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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MB12 (Proposed Pembrolizumab Biosimilar)
MB12 (Proposed Pembrolizumab Biosimilar) + Pemetrexed + Carboplatin/ Cisplatin
MB12 (Proposed Pembrolizumab Biosimilar)
200mg IV, every 3 weeks on Day 1
Pemetrexed
500 mg/m2 IV, every 3 weeks on Day 1
Carboplatin
Area under the curve (AUC) 5 IV, every 3 weeks on Day 1 for 4 cycles.
Cisplatin
75 mg/m2 IV, every 3 weeks on Day 1 for 4 cycles
EU- sourced Keytruda®
EU- sourced Keytruda® + Pemetrexed + Carboplatin/ Cisplatin
EU-sourced Keytruda®
200mg IV, every 3 weeks on Day 1
Pemetrexed
500 mg/m2 IV, every 3 weeks on Day 1
Carboplatin
Area under the curve (AUC) 5 IV, every 3 weeks on Day 1 for 4 cycles.
Cisplatin
75 mg/m2 IV, every 3 weeks on Day 1 for 4 cycles
US- sourced Keytruda®
US- sourced Keytruda® + Pemetrexed + Carboplatin/ Cisplatin
US-sourced Keytruda®
200mg IV, every 3 weeks on Day 1
Pemetrexed
500 mg/m2 IV, every 3 weeks on Day 1
Carboplatin
Area under the curve (AUC) 5 IV, every 3 weeks on Day 1 for 4 cycles.
Cisplatin
75 mg/m2 IV, every 3 weeks on Day 1 for 4 cycles
Interventions
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MB12 (Proposed Pembrolizumab Biosimilar)
200mg IV, every 3 weeks on Day 1
EU-sourced Keytruda®
200mg IV, every 3 weeks on Day 1
US-sourced Keytruda®
200mg IV, every 3 weeks on Day 1
Pemetrexed
500 mg/m2 IV, every 3 weeks on Day 1
Carboplatin
Area under the curve (AUC) 5 IV, every 3 weeks on Day 1 for 4 cycles.
Cisplatin
75 mg/m2 IV, every 3 weeks on Day 1 for 4 cycles
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. At least 1 radiographically measurable lesion according to response evaluation criteria in solid tumors (RECIST) 1.1.
4. Known status of PD-L1 expression.
5. Performance based on the Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
6. Adequate hepatic, renal, hematologic, endocrine, and coagulation function.
Exclusion Criteria
2. Known history of central nervous system metastases and/or carcinomatous meningitis.
3. 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).
4. Major surgery within 3 weeks of the first dose of study treatment.
5. Active autoimmune disease that has required systemic treatment in the last 2 years.
6. Contraindication and/or intolerance to the administration of pembrolizumab or known sensitivity to any component of pembrolizumab.
7. Has a known sensitivity to any component of cisplatin, carboplatin, or pemetrexed.
18 Years
ALL
No
Sponsors
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mAbxience Research S.L.
INDUSTRY
Responsible Party
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Locations
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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 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 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 124006
A Coruña, , Spain
Site 124013
Barcelona, , 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 124010
Santiago de Compostela, , Spain
Site 124015
Valencia, , Spain
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
Countries
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Central Contacts
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Other Identifiers
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MB12-C-02-24
Identifier Type: -
Identifier Source: org_study_id
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