What is MB12 studying for non-squamous non-small cell lung cancer?

MB12 is being studied as a proposed biosimilar to Keytruda® in combination with chemotherapy to treat advanced non-squamous non-small cell lung cancer. This trial aims to compare how MB12 and Keytruda® work in the body, their effectiveness, safety, and immune response. The study is sponsored by mAbxience Research S.L.

Who may be eligible for this non-small cell lung cancer clinical trial?

Adults aged 18 and older with advanced stage IV non-squamous non-small cell lung cancer who have not had prior systemic treatment may be eligible. Both males and females can participate. Key factors include no EGFR mutations or ALK translocations, and good performance status. Please review eligibility criteria for more details.

Is there any cost to participate in this non-small cell lung cancer clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses to and from the study sites may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID06687369

Randomized, Double-Blind Study Comparing MB12 Pembrolizumab Biosimilar and Keytruda Plus Chemotherapy for Advanced Non-Squamous NSCLC

Led by mAbxience Research S.L. · Updated on 2026-03-11

726

Participants Needed

151

Research Sites

65 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating MB12, a proposed pembrolizumab biosimilar, compared to Keytruda in combination with pemetrexed-platinum chemotherapy as the first treatment for patients with advanced metastatic non-squamous non-small cell lung cancer NSCLC. This randomized, double-blind, multicenter study aims to compare the pharmacokinetics, efficacy, safety, and immune response of MB12 and Keytruda in this patient population. Participants will be assigned to one of three groups MB12 with pemetrexed and carboplatin or cisplatin, European Union-sourced Keytruda with the same chemotherapy, or US-sourced Keytruda with the same chemotherapy. MB12 and Keytruda are given intravenously at 200mg every three weeks on Day 1. Pemetrexed is given at 500 mgm2 IV every three weeks on Day 1, while carboplatin or cisplatin is administered every three weeks for four cycles. During the study, participants will be monitored from Week 1 to Week 52 for drug levels in the body, treatment effectiveness, safety, and immune response. Key assessments include measuring pharmacokinetic bioequivalence and efficacy equivalence within the first 24 weeks, along with longer-term safety and immune monitoring. The study is led by mAbxience Research S.L. and is expected to continue until September 2027.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Adult male or female patients aged 18 years or older
Histologic or cytologic diagnosis of advanced stage IV non-squamous NSCLC without EGFR sensitizing mutation or ALK translocation
No prior systemic treatment for metastatic NSCLC
At least one measurable lesion by RECIST 1.1 criteria
Known PD-L1 expression status
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate liver, kidney, blood, endocrine, and coagulation function

You will not qualify if you...

Predominantly squamous cell histology NSCLC or presence of small cell elements
Known central nervous system metastases or carcinomatous meningitis
Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 therapies
Major surgery within 3 weeks before starting study treatment
Active autoimmune disease requiring systemic treatment in the last 2 years
Contraindications or intolerance to pembrolizumab or its components
Known sensitivity to cisplatin, carboplatin, or pemetrexed components

Research Team

Susana Millán, PhD

Camino Huerga

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