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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) | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

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)

NCT06687369•mAbxience Research S.L.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Adult male/female patients ≥18 years old at the time of signing the informed consent form (ICF).
•2. 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.
•3. At least 1 radiographically measurable lesion according to response evaluation criteria in solid tumors (RECIST) 1.1.
•4. Known status of PD-L1 expression.
•5. Performance based on the Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
•6. Adequate hepatic, renal, hematologic, endocrine, and coagulation function.

Exclusion Criteria

•2. Known history of central nervous system metastases and/or carcinomatous meningitis.
•3. 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).
•4. Major surgery within 3 weeks of the first dose of study treatment.
•5. Active autoimmune disease that has required systemic treatment in the last 2 years.
•6. Contraindication and/or intolerance to the administration of pembrolizumab or known sensitivity to any component of pembrolizumab.
•7. Has a known sensitivity to any component of cisplatin, carboplatin, or pemetrexed.

Locations (151)

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 108004

Batumi, Georgia

Site 108005

Kutaisi, Georgia

Site 108011

Marneuli, Georgia

Key Dates

Start Date

December 30, 2024

Primary Completion Date

June 1, 2026

Completion Date

September 1, 2027

Last Updated

March 11, 2026

Enrollment

726

ESTIMATED participants

Conditions

Non Squamous Non Small Cell Lung Cancer

Interventions

MB12 (Proposed Pembrolizumab Biosimilar)

DRUG

EU-sourced Keytruda®

DRUG

US-sourced Keytruda®

DRUG

Pemetrexed

DRUG

Carboplatin

DRUG

Cisplatin

DRUG

Contacts

Susana Millán, PhD

CONTACT

+34917711500 Susana.Millan@mabxience.com

Camino Huerga

CONTACT

+34917711500 Camino.Huerga@mabxience.com