Clinical trial NCT06687369: A Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) to Keytruda® in Non-small Cell Lung Cancer (BENITO Study)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Non Squamous Non Small Cell Lung Cancer
Lead sponsor: mAbxience Research S.L.
Sponsor class: INDUSTRY
First posted: 2024-11-13
Enrollment: 726
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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:

1. 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.
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.

Primary outcomes:
measure: To demonstrate the pharmacokinetic (PK) bioequivalence of MB12, EU-sourced Keytruda® and US-sourced Keytruda® in combination with chemotherapy
timeFrame: Week 1 - Week 24
measure: 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).
timeFrame: Week 1 - Week 24
Secondary outcomes:
measure: To assess the efficacy of MB12 as compared with Keytruda® based on other efficacy parameters and timepoints over the study period.
timeFrame: Week 1 - Week 52
measure: 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.
timeFrame: Week 1 - Week 52
measure: To assess the safety and tolerability of MB12 as compared with Keytruda®
timeFrame: Week 1 - Week 52
measure: To assess the immunogenicity of MB12 as compared with Keytruda®
timeFrame: Week 1 - Week 52
Other outcomes:
Locations:
city: Batumi
country: Georgia
facility: Site 108004
city: Kutaisi
country: Georgia
facility: Site 108005
city: Marneuli
country: Georgia
facility: Site 108011
city: Tbilisi
country: Georgia
facility: Site 108002
city: Tbilisi
country: Georgia
facility: Site 108003
city: Tbilisi
country: Georgia
facility: Site 108006
city: Tbilisi
country: Georgia
facility: Site 108007
city: Tbilisi
country: Georgia
facility: Site 108009
city: Hakodate-shi
country: Japan
facility: Site 207002
city: Okayama-shi
country: Japan
facility: Site 207012
city: Shinagawa-Ku
country: Japan
facility: Site 207010
city: Shizuoka-shi
country: Japan
facility: Site 207001
city: Chisinau
country: Moldova, Republic of
facility: Research site 116001
city: Belgrade
country: Serbia
facility: Site 121001
city: Belgrade
country: Serbia
facility: Site 121002
city: Kragujevac
country: Serbia
facility: Site 121003
city: Sremska Kamenica
country: Serbia
facility: Site 121004
city: Užice
country: Serbia
facility: Site 121005
Study officials:
References: