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

Last updated: May 29, 2025
Sponsor: mAbxience Research S.L.
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

MB12 (Proposed Pembrolizumab Biosimilar)

US-sourced Keytruda®

Carboplatin

Clinical Study ID

NCT06687369
MB12-C-02-24
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Adult male/female patients ≥18 years old at the time of signing the informed consentform (ICF).

  2. Histologic or cytologic diagnosis of advanced NSCLC, stage IV (defined by the 8thedition of the Tumor Node Metastasis [TNM] classification), with no EGFR sensitizing (activating) mutation or ALK translocation, and who have not received prior systemictreatment for metastatic NSCLC. In those patients in whom the pleural or pericardialeffusion is the only location of metastatic disease, confirmation of its malignantetiology is required.

  3. At least 1 radiographically measurable lesion according to response evaluationcriteria in solid tumors (RECIST) 1.1.

  4. Known status of PD-L1 expression.

  5. Performance based on the Eastern Cooperative Oncology Group (ECOG) performancestatus ≤1.

  6. Adequate hepatic, renal, hematologic, endocrine, and coagulation function.

Exclusion

Exclusion Criteria:

  1. Predominantly squamous cell histology NSCLC. Mixed tumors will be categorized by thepredominant cell type; if small cell elements are present, the patient is noteligible.

  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, oranti-cytotoxic T lymphocyte associated protein (CTLA)-4 therapy (includingipilimumab or any other antibody or drug that specifically targets co-stimulation ofT-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 knownsensitivity to any component of pembrolizumab.

  7. Has a known sensitivity to any component of cisplatin, carboplatin, or pemetrexed.

Study Design

Total Participants: 726
Treatment Group(s): 6
Primary Treatment: MB12 (Proposed Pembrolizumab Biosimilar)
Phase: 3
Study Start date:
December 30, 2024
Estimated Completion Date:
September 30, 2027

Connect with a study center

  • Site 108004

    Batumi,
    Georgia

    Active - Recruiting

  • Site 108005

    Kutaisi,
    Georgia

    Active - Recruiting

  • Site 108011

    Marneuli,
    Georgia

    Active - Recruiting

  • Site 108002

    Tbilisi,
    Georgia

    Active - Recruiting

  • Site 108003

    Tbilisi,
    Georgia

    Active - Recruiting

  • Site 108006

    Tbilisi,
    Georgia

    Active - Recruiting

  • Site 108007

    Tbilisi,
    Georgia

    Active - Recruiting

  • Site 108009

    Tbilisi,
    Georgia

    Active - Recruiting

  • Site 207002

    Hakodate-shi,
    Japan

    Active - Recruiting

  • Site 207012

    Okayama-shi,
    Japan

    Active - Recruiting

  • Site 207010

    Shinagawa-Ku,
    Japan

    Active - Recruiting

  • Site 27010

    Shinagawa-Ku,
    Japan

    Active - Recruiting

  • Site 207001

    Shizuoka-shi,
    Japan

    Active - Recruiting

  • Research site 116001

    Chisinau,
    Moldova, Republic of

    Active - Recruiting

  • Site 121001

    Belgrade,
    Serbia

    Active - Recruiting

  • Site 121002

    Belgrade,
    Serbia

    Active - Recruiting

  • Site 1201003

    Kragujevac,
    Serbia

    Active - Recruiting

  • Site 121003

    Kragujevac,
    Serbia

    Active - Recruiting

  • Site 121004

    Sremska Kamenica,
    Serbia

    Active - Recruiting

  • Site 121005

    Užice,
    Serbia

    Active - Recruiting

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