A Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) to Keytruda® in Non-small Cell Lung Cancer (BENITO Study)
Phase 3
Not yet recruiting
- Conditions
- Interventions
- Registration Number
- NCT06687369
- Lead Sponsor
- mAbxience Research S.L.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 726
Inclusion Criteria
- 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.
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Exclusion Criteria
- 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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MB12 (Proposed Pembrolizumab Biosimilar) Cisplatin MB12 (Proposed Pembrolizumab Biosimilar) + Pemetrexed + Carboplatin/ Cisplatin EU- sourced Keytruda® EU-sourced Keytruda® EU- sourced Keytruda® + Pemetrexed + Carboplatin/ Cisplatin EU- sourced Keytruda® Pemetrexed EU- sourced Keytruda® + Pemetrexed + Carboplatin/ Cisplatin MB12 (Proposed Pembrolizumab Biosimilar) MB12 (Proposed Pembrolizumab Biosimilar) MB12 (Proposed Pembrolizumab Biosimilar) + Pemetrexed + Carboplatin/ Cisplatin MB12 (Proposed Pembrolizumab Biosimilar) Pemetrexed MB12 (Proposed Pembrolizumab Biosimilar) + Pemetrexed + Carboplatin/ Cisplatin MB12 (Proposed Pembrolizumab Biosimilar) Carboplatin MB12 (Proposed Pembrolizumab Biosimilar) + Pemetrexed + Carboplatin/ Cisplatin EU- sourced Keytruda® Carboplatin EU- sourced Keytruda® + Pemetrexed + Carboplatin/ Cisplatin EU- sourced Keytruda® Cisplatin EU- sourced Keytruda® + Pemetrexed + Carboplatin/ Cisplatin US- sourced Keytruda® US-sourced Keytruda® US- sourced Keytruda® + Pemetrexed + Carboplatin/ Cisplatin US- sourced Keytruda® Pemetrexed US- sourced Keytruda® + Pemetrexed + Carboplatin/ Cisplatin US- sourced Keytruda® Carboplatin US- sourced Keytruda® + Pemetrexed + Carboplatin/ Cisplatin US- sourced Keytruda® Cisplatin US- sourced Keytruda® + Pemetrexed + Carboplatin/ Cisplatin
- Primary Outcome Measures
Name Time Method To demonstrate the pharmacokinetic (PK) bioequivalence of MB12, EU-sourced Keytruda® and US-sourced Keytruda® in combination with chemotherapy Week 1 - Week 24 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.
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). Week 1 - Week 24 Objective response rate (ORR), up to and including 24 weeks (end of Cycle 8)
- Secondary Outcome Measures
Name Time Method To assess the efficacy of MB12 as compared with Keytruda® based on other efficacy parameters and timepoints over the study period. Week 1 - Week 52 Objective response rate (ORR), Progression-free survival (PFS), Duration of response (DOR) and Overall survival (OS)
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. Week 1 - Week 52 Maximum concentration (Cmax), Time to maximum concentration (Tmax), Minimum concentration (Ctrough), Clearance (CL), Elimination half-life (t1/2), Distribution volume (Vd)
To assess the safety and tolerability of MB12 as compared with Keytruda® Week 1 - Week 52 Treatment-emergent adverse events (TEAEs)
To assess the immunogenicity of MB12 as compared with Keytruda® Week 1 - Week 52 Anti-drug antibodies (ADAs) and Neutralizing antibodies (NAbs) in ADA-positive samples