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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)

Status: Recruiting
Location: See all (151) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Armenia
Site 101001
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Yerevan
Site 101002
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Yerevan
Site 101003
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Yerevan
Site 101004
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Yerevan
Bosnia and Herzegovina
Site 103001
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Sarajevo
Site 103002
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Tuzla
Site 103003
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Zenica
Georgia
Site 108004
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Batumi
Site 108005
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Kutaisi
Site 108011
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Marneuli
Site 108001
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Tbilisi
Site 108002
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Tbilisi
Site 108003
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Tbilisi
Site 108006
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Tbilisi
Site 108007
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Tbilisi
Site 108008
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Tbilisi
Site 108009
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Tbilisi
Site 108010
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Tbilisi
Site 108012
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Tbilisi
Greece
Site 110006
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Athens
Site 110003
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Kifissia
Site 110004
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Larissa
Site 110009
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Pátrai
Site 110001
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Thessaloniki
Site 110002
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Thessaloniki
Site 110005
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Thessaloniki
Site 110008
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Thessaloniki
Site 110010
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Volos
Italy
Site 113012
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Brescia
Site 113010
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Cremona
Site 113007
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Genova
Site 113011
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Lecce
Site 113009
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Meldola
Site 113001
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Pavia
Site 113003
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Roma
Site 113006
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Roma
Site 113005
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Siena
Site 113008
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Torino
Japan
Site 207002
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Hakodate-shi
Site 207012
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Okayama
Site 207010
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Shinagawa-ku
Site 207001
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Shizuoka
Jordan
Site 114001
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Amman
Site 114002
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Amman
Site 114003
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Amman
Site 114004
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Amman
Site 114005
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Amman
Site 114007
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Amman
Site 114006
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Irbid
Malaysia
Site 202001
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Cheras
Site 202002
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Kota Bharu
Site 202003
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Kuala Selangor
Panama
Site 304001
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Panama City
Site 304002
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Panama City
Site 304003
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Panama City
Philippines
Site 203006
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Bacolod City
Site 203003
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Baguio City
Site 203004
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Iloilo City
Site 203009
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Iloilo City
Site 203005
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Makati City
Site 203007
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Manila
Site 203002
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Quezon City
Poland
Site 118004
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Katowice
Site 118001
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Lodz
Site 118005
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Lublin
Site 118002
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Prabuty
Site 118003
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Słupsk
Portugal
Site 119001
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Lisbon
Site 119002
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Matosinhos Municipality
Site 119003
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Porto
Republic of Korea
Site 204005
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Busan
Site 204004
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Gyeonggi-do
Site 204006
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Gyeonggi-do
Site 204001
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Incheon
Site 204002
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Seoul
Site 204007
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Seoul
Republic of Moldova
Research site 116001
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Chisinau
Romania
Site 120001
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Cluj-napoca
Site 120003
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Craiova
Site 120004
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Craiova
Site 120006
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Floreşti
Site 120005
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Timișoara
Serbia
Site 121001
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Belgrade
Site 121002
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Belgrade
Site 121004
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Kamenitz
Site 121003
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Kragujevac
Site 121005
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Užice
Slovakia
Site 122003
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Bardejov
Site 122001
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Bratislava
Site 122002
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Partizánske
South Africa
Site 123005
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Johannesburg
Site 123006
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Johannesburg
Site 123007
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Kraaifontein
Site 123004
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Kwazulu
Site 123002
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Port Elizabeth
Site 123001
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Pretoria
Site 123003
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Pretoria
Spain
Site 124006
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A Coruña
Site 124002
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Barcelona
Site 124013
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Barcelona
Site 124007
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Madrid
Site 124009
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Madrid
Site 124011
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Madrid
Site 124012
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Madrid
Site 124008
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Málaga
Site 124016
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Murcia
Site 124003
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Oviedo
Site 124001
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Palma De Mallorca
Site 124014
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Pontevedra
Site 124005
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Sant Joan Despí
Site 124010
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Santiago De Compostela
Site 124004
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Seville
Site 124015
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Valencia
Taiwan
Site 205003
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Kaohsiung City
Site 205009
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Kaohsiung City
Site 205004
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Liuying
Site 205002
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Taichung
Site 205008
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Taichung
Site 205005
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Tainan
Site 205006
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Taipei
Site 205007
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Taipei
Thailand
Site 206004
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Bangkok
Site 206005
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Bangkok
Site 206001
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Chiang Mai
Site 206007
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Chiang Rai
Site 206003
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Khon Kaen
Site 206002
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Nakhon Nayok
Site 206006
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Songkhla
Tunisia
Site 112002
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Aryanah
Site 112003
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Aryanah
Site 112004
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Aryanah
Site 112001
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Sfax
Site 112005
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Tunis
Turkey
Site 125017
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Adana
Site 125006
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Alanya
Site 125001
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Ankara
Site 125002
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Ankara
Site 125004
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Ankara
Site 125008
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Ankara
Site 125009
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Ankara
Site 125019
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Ankara
Site 125003
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Istanbul
Site 125010
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Istanbul
Site 125011
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Istanbul
Site 125012
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Istanbul
Site 125018
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Istanbul
Site 125015
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Izmir
Site 125023
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Sakarya
Site 125013
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Samsun
Site 125007
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Tekirdağ
Site 125014
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Yüreğir
Contact Information
Primary
Susana Millán, PhD
Susana.Millan@mabxience.com
+34917711500
Backup
Camino Huerga
Camino.Huerga@mabxience.com
+34917711500
Time Frame
Start Date: 2024-12-30
Estimated Completion Date: 2027-09
Participants
Target number of participants: 726
Treatments
Experimental: MB12 (Proposed Pembrolizumab Biosimilar)
MB12 (Proposed Pembrolizumab Biosimilar) + Pemetrexed + Carboplatin/ Cisplatin
Active_comparator: EU- sourced Keytruda®
EU- sourced Keytruda® + Pemetrexed + Carboplatin/ Cisplatin
Active_comparator: US- sourced Keytruda®
US- sourced Keytruda® + Pemetrexed + Carboplatin/ Cisplatin
Sponsors
Leads: mAbxience Research S.L.

This content was sourced from clinicaltrials.gov