問卷
Log In
繁中 EN
TPIDB
TPIDB Outstanding PI
TPIDB > Search Result > Clinical Trials List

Clinical Trials List

Protocol NumberMB12-C-02-24
NCT Number(ClinicalTrials.gov Identfier)NCT06687369
Active

2024-11-01 - 2027-04-30

Others

Recruiting9

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

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)

  • Trial Applicant

    Pharmaceutical Research Associates Taiwan Inc.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/04/22

Investigators and Locations

Principal Investigator 廖斌志 無
National Taiwan University Cancer Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TSUNG -YING YANG 無
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 高婉真 無
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator CHIN-CHOU WANG 無
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator kang-Yun LEE Division of Thoracic Medicine
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yuh-Min Chen 無
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Te-Chun Hsia 無
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jen-Yu Hung 無
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chun-Hui Lee
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Non Squamous Non Small Cell Lung Cancer

Objectives

Common Primary Objectives • To demonstrate the pharmacokinetic (PK) bioequivalence of MB12, EU Keytruda®, and US Keytruda® in combination with chemotherapy as first-line treatment for patients with advanced/metastatic non-squamous non-small cell lung cancer (NSCLC) (any programmed cell death ligand [PD-L]-1 phenotype). • To demonstrate the efficacy equivalence of MB12 and Keytruda® in combination with chemotherapy as first-line treatment for patients with advanced/metastatic non-squamous NSCLC (any PD-L1 phenotype). Secondary Objectives • To evaluate the efficacy of MB12 compared to Keytruda® based on other efficacy parameters and time points during the trial. • To compare the PK characteristics of MB12 compared to Keytruda® based on other PK parameters and time points during the trial (not included in the primary PK endpoint). • To evaluate the safety and tolerability of MB12 compared to Keytruda® during the trial. • Evaluate the immunogenicity of MB12 compared to Keytruda® during the trial.

Test Drug

Injectable

Active Ingredient

MB12

Dosage Form

270

Dosage

100 mg/ 4ml/ vial

Endpoints

Key pharmacokinetic endpoints:

o Area under the concentration-time curve (AUC) between cycle 1 and cycle 2 (AUC at 0 to 504 hours post-treatment [AUC0-504])
o Steady-state AUC between cycle 7 and cycle 8 (AUCss)
Key efficacy endpoints:

o Objective response rate (ORR), based on the best ORR assessed by a blinded independent central review (BICR) for up to 24 weeks (including week 24 [end of cycle 8])

Inclution Criteria

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.

Exclusion Criteria

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.

The Estimated Number of Participants

  • Taiwan

    40 participants

  • Global

    726 participants

聯絡我們

台灣臨床試驗主持人資料庫 TPIDB

All Contents Copyright 2020 台灣臨床試驗主持人資料庫TPIDB