Non Squamous Non Small Cell Lung CancerPhase 3NCT06687369
A Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) to Keytruda® in Non-small Cell Lung Cancer (BENITO Study)
A Phase 3 study testing MB12 (Proposed Pembrolizumab Biosimilar), EU-sourced Keytruda® and US-sourced Keytruda® in people with Non Squamous Non Small Cell Lung Cancer, run by mAbxience Research S.L. at 173 sites in 24 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Squamous Non Small Cell Lung Cancer
- What is being tested?
- MB12 (Proposed Pembrolizumab Biosimilar), EU-sourced Keytruda® and US-sourced Keytruda®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 726 participants
- Where
- 173 sitesin 24 countries
- Study dates
- 30 Dec 2024to Sep 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
173 sites in 24 countries.
173 sites in 24 countries
Brazil22 sites
Site 301014
Barretos
Site 301026
Belém
Site 301002
Belo Horizonte
Site 301023
Bento Gonçalves
Site 301006
Blumenau
Site 301019
Caxias do Sul
Site 301015
Curitiba
Site 301028
Curitiba
Site 301024
Florianópolis
Site 301010
Fortaleza
Site 301011
Ijuí
Site 301008
Itajaí
Site 301012
Jaú
Site 301018
Natal
Site 301003
Porto Alegre
Site 301005
Porto Alegre
Site 301007
Porto Alegre
Site 301016
Porto Alegre
Site 301022
Recife
Site 301009
Rio de Janeiro
Site 301020
Santo André
Site 301001
São José do Rio Preto
Turkey (Türkiye)18 sites
Site 125017
Adana
Site 125006
Alanya
Site 125001
Ankara
Site 125002
Ankara
Site 125004
Ankara
Site 125008
Ankara
Site 125009
Ankara
Site 125019
Ankara
Site 125003
Istanbul
Site 125010
Istanbul
Site 125011
Istanbul
Site 125012
Istanbul
Site 125018
Istanbul
Site 125015
Izmir
Site 125023
Sakarya
Site 125013
Samsun
Site 125007
Tekirdağ
Site 125014
Yüreğir
Spain16 sites
Site 124006
A Coruña
Site 124002
Barcelona
Site 124013
Barcelona
Site 124007
Madrid
Site 124009
Madrid
Site 124011
Madrid
Site 124012
Madrid
Site 124008
Málaga
Site 124016
Murcia
Site 124003
Oviedo
Site 124001
Palma de Mallorca
Site 124014
Pontevedra
Site 124005
Sant Joan Despí
Site 124010
Santiago de Compostela
Site 124004
Seville
Site 124015
Valencia
Georgia12 sites
Site 108004
Batumi
Site 108005
Kutaisi
Site 108011
Marneuli
Site 108001
Tbilisi
Site 108002
Tbilisi
Site 108003
Tbilisi
Site 108006
Tbilisi
Site 108007
Tbilisi
Site 108008
Tbilisi
Site 108009
Tbilisi
Site 108010
Tbilisi
Site 108012
Tbilisi
Italy10 sites
Site 113012
Brescia
Site 113010
Cremona
Site 113007
Genova
Site 113011
Lecce
Site 113009
Meldola
Site 113001
Pavia
Site 113003
Roma
Site 113006
Roma
Site 113005
Siena
Site 113008
Torino
Greece9 sites
Site 110006
Athens
Site 110003
Kifissia
Site 110004
Larissa
Site 110009
Pátrai
Site 110001
Thessaloniki
Site 110002
Thessaloniki
Site 110005
Thessaloniki
Site 110008
Thessaloniki
Site 110010
Volos
Taiwan8 sites
Site 205003
Kaohsiung City
Site 205009
Kaohsiung City
Site 205004
Liuying
Site 205002
Taichung
Site 205008
Taichung
Site 205005
Tainan
Site 205006
Taipei
Site 205007
Taipei
Jordan7 sites
Site 114001
Amman
Site 114002
Amman
Site 114003
Amman
Site 114004
Amman
Site 114005
Amman
Site 114007
Amman
Site 114006
Irbid
Philippines7 sites
Site 203006
Bacolod City
Site 203003
Baguio City
Site 203004
Iloilo City
Site 203009
Iloilo City
Site 203005
Makati City
Site 203007
Manila
Site 203002
Quezon City
South Africa7 sites
Site 123005
Johannesburg
Site 123006
Johannesburg
Site 123007
Kraaifontein
Site 123004
KwaZulu
Site 123002
Port Elizabeth
Site 123001
Pretoria
Site 123003
Pretoria
Thailand7 sites
Site 206004
Bangkok
Site 206005
Bangkok
Site 206001
Chiang Mai
Site 206007
Chiang Rai
Site 206003
Khon Kaen
Site 206002
Nakhon Nayok
Site 206006
Songkhla
South Korea6 sites
Site 204005
Busan
Site 204004
Gyeonggi-do
Site 204006
Gyeonggi-do
Site 204001
Incheon
Site 204002
Seoul
Site 204007
Seoul
Poland5 sites
Site 118004
Katowice
Site 118001
Lodz
Site 118005
Lublin
Site 118002
Prabuty
Site 118003
Słupsk
Romania5 sites
Site 120001
Cluj-Napoca
Site 120003
Craiova
Site 120004
Craiova
Site 120006
Floreşti
Site 120005
Timișoara
Serbia5 sites
Site 121001
Belgrade
Site 121002
Belgrade
Site 121004
Kamenitz
Site 121003
Kragujevac
Site 121005
Užice
Tunisia5 sites
Site 112002
Aryanah
Site 112003
Aryanah
Site 112004
Aryanah
Site 112001
Sfax
Site 112005
Tunis
Armenia4 sites
Site 101001
Yerevan
Site 101002
Yerevan
Site 101003
Yerevan
Site 101004
Yerevan
Japan4 sites
Site 207002
Hakodate-shi
Site 207012
Okayama
Site 207010
Shinagawa-Ku
Site 207001
Shizuoka
Bosnia and Herzegovina3 sites
Site 103001
Sarajevo
Site 103002
Tuzla
Site 103003
Zenica
Malaysia3 sites
Site 202001
Cheras
Site 202002
Kota Bharu
Site 202003
Kuala Selangor
Panama3 sites
Site 304001
Panama City
Site 304002
Panama City
Site 304003
Panama City
Portugal3 sites
Site 119001
Lisbon
Site 119002
Matosinhos Municipality
Site 119003
Porto
Slovakia3 sites
Site 122003
Bardejov
Site 122001
Bratislava
Site 122002
Partizánske
About this study
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)
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
- Non Squamous Non Small Cell Lung Cancer
- Being tested
- MB12 (Proposed Pembrolizumab Biosimilar), EU-sourced Keytruda®, US-sourced Keytruda®, Pemetrexed, Carboplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MB12 (Proposed Pembrolizumab Biosimilar)Drug
200mg IV, every 3 weeks on Day 1
EU-sourced Keytruda®Drug
200mg IV, every 3 weeks on Day 1
US-sourced Keytruda®Drug
200mg IV, every 3 weeks on Day 1
PemetrexedDrug
500 mg/m2 IV, every 3 weeks on Day 1
CarboplatinDrug
Area under the curve (AUC) 5 IV, every 3 weeks on Day 1 for 4 cycles.
CisplatinDrug
75 mg/m2 IV, every 3 weeks on Day 1 for 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| MB12 (Proposed Pembrolizumab Biosimilar) | Experimental | MB12 (Proposed Pembrolizumab Biosimilar) + Pemetrexed + Carboplatin/ Cisplatin Receives: Drug: MB12 (Proposed Pembrolizumab Biosimilar); Drug: Pemetrexed; Drug: Carboplatin; Drug: Cisplatin |
| EU- sourced Keytruda® | Active comparator | EU- sourced Keytruda® + Pemetrexed + Carboplatin/ Cisplatin Receives: Drug: EU-sourced Keytruda®; Drug: Pemetrexed; Drug: Carboplatin; Drug: Cisplatin |
| US- sourced Keytruda® | Active comparator | US- sourced Keytruda® + Pemetrexed + Carboplatin/ Cisplatin Receives: Drug: US-sourced Keytruda®; Drug: Pemetrexed; Drug: Carboplatin; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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.
Objective response rate (ORR), Progression-free survival (PFS), Duration of response (DOR) and Overall survival (OS)
Measured: 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.
Maximum concentration (Cmax), Time to maximum concentration (Tmax), Minimum concentration (Ctrough), Clearance (CL), Elimination half-life (t1/2), Distribution volume (Vd)
Measured: Week 1 - Week 52
To assess the safety and tolerability of MB12 as compared with Keytruda®
Treatment-emergent adverse events (TEAEs)
Measured: Week 1 - Week 52
To assess the immunogenicity of MB12 as compared with Keytruda®
Anti-drug antibodies (ADAs) and Neutralizing antibodies (NAbs) in ADA-positive samples
Measured: Week 1 - Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start30 Dec 2024
- Primary completion31 Aug 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Squamous Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 726 participants (estimated)
Sponsor and investigators
- Lead sponsor
- mAbxience Research S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06687369
- Sponsor's protocol ID
- MB12-C-02-24
- Status last verified
- Sep 2026
- First submitted
- 11 Nov 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No