Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) to Keytruda® in Non-small Cell Lung Cancer (BENITO Study)
Sponsor: mAbxience Research S.L.
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
726
Start Date
2024-12-30
Completion Date
2027-09
Last Updated
2026-09-10
Healthy Volunteers
No
Conditions
Interventions
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
Locations (173)
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 301014
Barretos, Brazil
Site 301026
Belém, Brazil
Site 301002
Belo Horizonte, Brazil
Site 301023
Bento Gonçalves, Brazil
Site 301006
Blumenau, Brazil
Site 301019
Caxias do Sul, Brazil
Site 301015
Curitiba, Brazil
Site 301028
Curitiba, Brazil
Site 301024
Florianópolis, Brazil
Site 301010
Fortaleza, Brazil
Site 301011
Ijuí, Brazil
Site 301008
Itajaí, Brazil
Site 301012
Jaú, Brazil
Site 301018
Natal, Brazil
Site 301003
Porto Alegre, Brazil
Site 301005
Porto Alegre, Brazil
Site 301007
Porto Alegre, Brazil
Site 301016
Porto Alegre, Brazil
Site 301022
Recife, Brazil
Site 301009
Rio de Janeiro, Brazil
Site 301020
Santo André, Brazil
Site 301001
São José do Rio Preto, Brazil
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