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A Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) to Keytruda® in Non-small Cell Lung Cancer (BENITO Study)
Led by mAbxience Research S.L. · Updated on 2026-03-11
726
Participants Needed
151
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) to Keytruda® in Non-small Cell Lung Cancer (BENITO Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult male or female patients 18 years or older at the time of informed consent
- Diagnosis of advanced stage IV non-squamous NSCLC without EGFR activating mutation or ALK translocation
- No prior systemic treatment for metastatic NSCLC
- At least one measurable lesion on imaging according to RECIST 1.1
- Known PD-L1 expression status
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate liver, kidney, blood, endocrine, and clotting functions
You will not qualify if you...
- Predominantly squamous cell NSCLC or presence of small cell tumor elements
- History of central nervous system metastases or carcinomatous meningitis
- Prior treatment with PD-1, PD-L1, PD-L2, CD137, or CTLA-4 targeted therapies
- Major surgery within 3 weeks before starting study treatment
- Active autoimmune disease requiring systemic treatment in the past 2 years
- Known intolerance or sensitivity to pembrolizumab or its components
- Known sensitivity to cisplatin, carboplatin, or pemetrexed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 151 locations
1
Site 101001
Yerevan, Armenia
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2
Site 101002
Yerevan, Armenia
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3
Site 101003
Yerevan, Armenia
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4
Site 101004
Yerevan, Armenia
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5
Site 103001
Sarajevo, Bosnia and Herzegovina
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6
Site 103002
Tuzla, Bosnia and Herzegovina
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7
Site 103003
Zenica, Bosnia and Herzegovina
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8
Site 108004
Batumi, Georgia
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9
Site 108005
Kutaisi, Georgia
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10
Site 108011
Marneuli, Georgia
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11
Site 108001
Tbilisi, Georgia
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12
Site 108002
Tbilisi, Georgia
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13
Site 108003
Tbilisi, Georgia
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14
Site 108006
Tbilisi, Georgia
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15
Site 108007
Tbilisi, Georgia
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16
Site 108008
Tbilisi, Georgia
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17
Site 108009
Tbilisi, Georgia
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18
Site 108010
Tbilisi, Georgia
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19
Site 108012
Tbilisi, Georgia
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20
Site 110006
Athens, Greece
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21
Site 110003
Kifissia, Greece
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22
Site 110004
Larissa, Greece
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23
Site 110009
Pátrai, Greece
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24
Site 110001
Thessaloniki, Greece
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25
Site 110002
Thessaloniki, Greece
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26
Site 110005
Thessaloniki, Greece
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27
Site 110008
Thessaloniki, Greece
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28
Site 110010
Volos, Greece
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29
Site 113012
Brescia, Italy
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30
Site 113010
Cremona, Italy
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31
Site 113007
Genova, Italy
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32
Site 113011
Lecce, Italy
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33
Site 113009
Meldola, Italy
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34
Site 113001
Pavia, Italy
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35
Site 113003
Roma, Italy
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36
Site 113006
Roma, Italy
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37
Site 113005
Siena, Italy
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38
Site 113008
Torino, Italy
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39
Site 207002
Hakodate-shi, Japan
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40
Site 207012
Okayama, Japan
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41
Site 207010
Shinagawa-Ku, Japan
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42
Site 207001
Shizuoka, Japan
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43
Site 114001
Amman, Jordan
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44
Site 114002
Amman, Jordan
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45
Site 114003
Amman, Jordan
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46
Site 114004
Amman, Jordan
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47
Site 114005
Amman, Jordan
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48
Site 114007
Amman, Jordan
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49
Site 114006
Irbid, Jordan
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50
Site 202001
Cheras, Malaysia
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51
Site 202002
Kota Bharu, Malaysia
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52
Site 202003
Kuala Selangor, Malaysia
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53
Research site 116001
Chisinau, Moldova
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54
Site 304001
Panama City, Panama
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55
Site 304002
Panama City, Panama
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56
Site 304003
Panama City, Panama
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57
Site 203006
Bacolod City, Philippines
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58
Site 203003
Baguio City, Philippines
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59
Site 203004
Iloilo City, Philippines
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60
Site 203009
Iloilo City, Philippines
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61
Site 203005
Makati City, Philippines
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62
Site 203007
Manila, Philippines
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63
Site 203002
Quezon City, Philippines
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64
Site 118004
Katowice, Poland
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65
Site 118001
Lodz, Poland
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66
Site 118005
Lublin, Poland
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67
Site 118002
Prabuty, Poland
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68
Site 118003
Słupsk, Poland
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69
Site 119001
Lisbon, Portugal
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70
Site 119002
Matosinhos Municipality, Portugal
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71
Site 119003
Porto, Portugal
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72
Site 120001
Cluj-Napoca, Romania
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73
Site 120003
Craiova, Romania
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74
Site 120004
Craiova, Romania
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75
Site 120006
Floreşti, Romania
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76
Site 120005
Timișoara, Romania
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77
Site 121001
Belgrade, Serbia
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78
Site 121002
Belgrade, Serbia
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79
Site 121004
Kamenitz, Serbia
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80
Site 121003
Kragujevac, Serbia
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81
Site 121005
Užice, Serbia
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82
Site 122003
Bardejov, Slovakia
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83
Site 122001
Bratislava, Slovakia
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84
Site 122002
Partizánske, Slovakia
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85
Site 123005
Johannesburg, South Africa
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86
Site 123006
Johannesburg, South Africa
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87
Site 123007
Kraaifontein, South Africa
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88
Site 123004
KwaZulu, South Africa
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89
Site 123002
Port Elizabeth, South Africa
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90
Site 123001
Pretoria, South Africa
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91
Site 123003
Pretoria, South Africa
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92
Site 204005
Busan, South Korea
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93
Site 204004
Gyeonggi-do, South Korea
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94
Site 204006
Gyeonggi-do, South Korea
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95
Site 204001
Incheon, South Korea
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96
Site 204002
Seoul, South Korea
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97
Site 204007
Seoul, South Korea
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98
Site 124006
A Coruña, Spain
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99
Site 124002
Barcelona, Spain
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100
Site 124013
Barcelona, Spain
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101
Site 124007
Madrid, Spain
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102
Site 124009
Madrid, Spain
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103
Site 124011
Madrid, Spain
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104
Site 124012
Madrid, Spain
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105
Site 124008
Málaga, Spain
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106
Site 124016
Murcia, Spain
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107
Site 124003
Oviedo, Spain
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108
Site 124001
Palma de Mallorca, Spain
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109
Site 124014
Pontevedra, Spain
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110
Site 124005
Sant Joan Despí, Spain
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111
Site 124010
Santiago de Compostela, Spain
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112
Site 124004
Seville, Spain
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113
Site 124015
Valencia, Spain
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114
Site 205003
Kaohsiung City, Taiwan
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115
Site 205009
Kaohsiung City, Taiwan
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116
Site 205004
Liuying, Taiwan
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117
Site 205002
Taichung, Taiwan
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118
Site 205008
Taichung, Taiwan
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119
Site 205005
Tainan, Taiwan
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120
Site 205006
Taipei, Taiwan
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121
Site 205007
Taipei, Taiwan
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122
Site 206004
Bangkok, Thailand
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123
Site 206005
Bangkok, Thailand
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124
Site 206001
Chiang Mai, Thailand
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125
Site 206007
Chiang Rai, Thailand
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126
Site 206003
Khon Kaen, Thailand
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127
Site 206002
Nakhon Nayok, Thailand
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128
Site 206006
Songkhla, Thailand
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129
Site 112002
Aryanah, Tunisia
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130
Site 112003
Aryanah, Tunisia
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131
Site 112004
Aryanah, Tunisia
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132
Site 112001
Sfax, Tunisia
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133
Site 112005
Tunis, Tunisia
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134
Site 125017
Adana, Turkey (Türkiye)
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135
Site 125006
Alanya, Turkey (Türkiye)
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136
Site 125001
Ankara, Turkey (Türkiye)
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137
Site 125002
Ankara, Turkey (Türkiye)
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138
Site 125004
Ankara, Turkey (Türkiye)
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139
Site 125008
Ankara, Turkey (Türkiye)
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140
Site 125009
Ankara, Turkey (Türkiye)
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141
Site 125019
Ankara, Turkey (Türkiye)
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142
Site 125003
Istanbul, Turkey (Türkiye)
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143
Site 125010
Istanbul, Turkey (Türkiye)
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144
Site 125011
Istanbul, Turkey (Türkiye)
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145
Site 125012
Istanbul, Turkey (Türkiye)
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146
Site 125018
Istanbul, Turkey (Türkiye)
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147
Site 125015
Izmir, Turkey (Türkiye)
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148
Site 125023
Sakarya, Turkey (Türkiye)
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149
Site 125013
Samsun, Turkey (Türkiye)
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150
Site 125007
Tekirdağ, Turkey (Türkiye)
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151
Site 125014
Yüreğir, Turkey (Türkiye)
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Research Team
S
Susana Millán, PhD
CONTACT
C
Camino Huerga
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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