A Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) to Keytruda® in Non-small Cell Lung Cancer (BENITO Study)

Официальное название

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)

Обзор

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.

Вмешательства

• Препарат MB12 (Proposed Pembrolizumab Biosimilar)
  200mg IV, every 3 weeks on Day 1
• Препарат EU-sourced Keytruda®
  200mg IV, every 3 weeks on Day 1
• Препарат US-sourced Keytruda®
  200mg IV, every 3 weeks on Day 1
• Препарат Pemetrexed
  500 mg/m2 IV, every 3 weeks on Day 1
• Препарат Carboplatin
  Area under the curve (AUC) 5 IV, every 3 weeks on Day 1 for 4 cycles.
• Препарат Cisplatin
  75 mg/m2 IV, every 3 weeks on Day 1 for 4 cycles

Первичные конечные точки

• To demonstrate the pharmacokinetic (PK) bioequivalence of MB12, EU-sourced Keytruda® and US-sourced Keytruda® in combination with chemotherapy [Срок оценки: 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). [Срок оценки: Week 1 - Week 24]

Вторичные конечные точки (4)

• To assess the efficacy of MB12 as compared with Keytruda® based on other efficacy parameters and timepoints over the study period. [Срок оценки: 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. [Срок оценки: Week 1 - Week 52]
• To assess the safety and tolerability of MB12 as compared with Keytruda® [Срок оценки: Week 1 - Week 52]
• To assess the immunogenicity of MB12 as compared with Keytruda® [Срок оценки: Week 1 - Week 52]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 18 центров

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Испания · 16 центров

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Грузия · 12 центров

• Site 108004 — Batumi
• Site 108005 — Kutaisi
• Site 108011 — Marneuli
• Site 108001 — Tbilisi
• Site 108002 — Tbilisi
• Site 108003 — Tbilisi
• Site 108006 — Tbilisi
• Site 108007 — Tbilisi
• … и ещё 4 центра

Италия · 10 центров

• Site 113012 — Brescia
• Site 113010 — Cremona
• Site 113007 — Genova
• Site 113011 — Lecce
• Site 113009 — Meldola
• Site 113001 — Pavia
• Site 113003 — Roma
• Site 113006 — Roma
• … и ещё 2 центра

Греция · 9 центров

• Site 110006 — Athens
• Site 110003 — Kifissia
• Site 110004 — Larissa
• Site 110009 — Pátrai
• Site 110001 — Thessaloniki
• Site 110002 — Thessaloniki
• Site 110005 — Thessaloniki
• Site 110008 — Thessaloniki
• … и ещё 1 центр

Тайвань · 8 центров

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Иордания · 7 центров

• Site 114001 — Amman
• Site 114002 — Amman
• Site 114003 — Amman
• Site 114004 — Amman
• Site 114005 — Amman
• Site 114007 — Amman
• Site 114006 — Irbid

Филиппины · 7 центров

• 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

ЮАР · 7 центров

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Таиланд · 7 центров

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South Korea · 6 центров

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Польша · 5 центров

• Site 118004 — Katowice
• Site 118001 — Lodz
• Site 118005 — Lublin
• Site 118002 — Prabuty
• Site 118003 — Słupsk

Румыния · 5 центров

• Site 120001 — Cluj-Napoca
• Site 120003 — Craiova
• Site 120004 — Craiova
• Site 120006 — Floreşti
• Site 120005 — Timișoara

Сербия · 5 центров

• Site 121001 — Belgrade
• Site 121002 — Belgrade
• Site 121004 — Kamenitz
• Site 121003 — Kragujevac
• … и ещё 1 центр

Tunisia · 5 центров

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Армения · 4 центра

• Site 101001 — Yerevan
• Site 101002 — Yerevan
• Site 101003 — Yerevan
• Site 101004 — Yerevan

Япония · 4 центра

• Site 207002 — Hakodate-shi
• Site 207012 — Okayama
• Site 207010 — Shinagawa-Ku
• Site 207001 — Shizuoka

Bosnia and Herzegovina · 3 центра

• Site 103001 — Sarajevo
• Site 103002 — Tuzla
• Site 103003 — Zenica

Малайзия · 3 центра

• Site 202001 — Cheras
• Site 202002 — Kota Bharu
• Site 202003 — Kuala Selangor

Panama · 3 центра

• Site 304001 — Panama City
• Site 304002 — Panama City
• Site 304003 — Panama City

Португалия · 3 центра

• Site 119001 — Lisbon
• Site 119002 — Matosinhos Municipality
• Site 119003 — Porto

Словакия · 3 центра

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Moldova · 1 центр

• Research site 116001 — Chisinau

Идентификаторы

NCT: NCT06687369 · MB12-C-02-24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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