Randomized, Multicenter, Multinational, Double-Blind Study to Evaluate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) Versus Keytruda® in Subjects With Stage IV Non-Squamous Non-Small Cell Lung Cancer

aboratorio Elea Phoenix S.A.0 个研究点目标入组 0 人开始时间: 2023年12月29日最近更新: 2024年8月20日

适应症

试验速览

阶段: 3 期
状态: 尚未招募
发起方

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

性别: All

入选标准

•Body weight =50 kg at Screening.
•At least 1 radiographically measurable lesion per RECIST version 1.1, locally assessed.
•Life expectancy of at least 3 months.
•ECOG performance status of 0 to 1.
•Subjects with a negative COVID-19 test (done at the discretion of investigator or per local regulation) within previous 24 hours before randomization. In case of confirmed COVID-19 infection before Screening, documentation of resolution of infection by appropriate laboratory test is required.
•No history of prior malignancy, except for basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or cervical cancer in situ, or has undergone potentially curative therapy without evidence of disease recurrence for 3 years from the start of that therapy.
•Male subjects, if not surgically sterile, must either abstain from sexual intercourse or employ highly effective contraception (condoms or other barrier forms of contraception) during the study and for at least 6 months after the last dose of the study drug. Male subjects should also avoid semen donation or providing semen for in-vitro fertilization during the above-mentioned duration.
•Willing and able to provide written informed consent for the study before the initiation of any study-specific procedures.
•Greater than or equal to 18 years of age at the time of signing the ICF.
•Having newly diagnosed stage IV (defined by the eighth edition of the TNM classification) non-squamous NSCLC, without prior systemic treatment for the disease. For those subjects in whom the pleural or pericardial effusion is the only location of metastatic disease, confirmation of its malignant etiology is required.
•Programmed death-ligand 1 (PD-L1) expression =50%, locally dete

排除标准

•Active infection or a previous infection requiring intravenous systemic treatment within 30 days before the first dose of the study drug.
•Unwilling or unable to comply with scheduled visits, drug administration plan, laboratory tests, or other study procedures and study restrictions.
•Predominantly squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the subject is ineligible.
•Participation in another clinical trial or treatment with another investigational agent within 4 weeks or 5 half-lives before randomization, whichever is longer.
•Known actionable mutations for which there is an approved and available therapy.
•Known central nervous system metastases and/or carcinomatous meningitis.
•Previous systemic steroid therapy (prednisone at a dose of 10 mg or equivalent) within 3 days before the first dose of the study drug or receiving any other form of immunosuppressive medication. Subjects receiving daily steroid replacement therapy (daily prednisone at a dose of 5 to 7.5 mg or equivalent) could be included in the study.
•Subject who requires any other form of localized or systemic antineoplastic therapy during the study.
•Prior anti-programmed cell death-1 (anti-PD-1), anti-PD-L1, anti-programmed death-ligand 2 (anti-PD-L2), anti-CD137, or anti-cytotoxic T-lymphocyte antigen (CTLA)-4 therapy (including ipilimumab or any other antibody or drug that specifically targets co-stimulation of T-cells or immune checkpoints).
•Prior systemic cytotoxic chemotherapy, biological therapy, or major surgery within 3 weeks before the first dose of the study drug; have received thoracic radiation therapy of >30 gray (Gy) within 6 months before the first dose of the study drug. Palliative radiotherapy is allowed if completed >14 days before the first dose of the study drug.
•Known history of severe hypersensitivity to another monoclonal antibody.
•Active autoimmune disease which has required systemic treatment in the last 2 years before the first dose of the study drug (eg, disease modifying agents, corticosteroids, or immunosuppressive treatment). Replacement therapy (eg, thyroxine, insulin, or physiological corticosteroid replacement therapy for pituitary or adrenal insufficien

研究者

发起方

aboratorio Elea Phoenix S.A.

相似试验

进行中（未招募）

不适用

Randomized, multinational, multicenter, double-blind, placebo-controlled, two-armparallel group trial of rimonabant 20 mg OD for reducing the risk of majorcardiovascular events in abdominally obese patients with clustering risk factors - CRESCENDOPatients with abdominal obesity at increased risk for cardiovascular events (myocardial infarctio, stroke and cardiovascular death)MedDRA version: 8.0Level: LLTClassification code 10051615

EUCTR2005-002942-20-ATSanofi-Synthelabo Recherche17,000

进行中（未招募）

不适用

Randomized, multinational, multicenter, double-blind, placebo-controlled, two-arm parallel group trial of rimonabant 20 mg OD for reducing the risk of major cardiovascular events in abdominally obese patients with clustering risk factors - CRESCENDOPatients with abdominal obesity at increased risk for cardiovascular events (myocardial infarctio, stroke and cardiovascular death)MedDRA version: 10.1Level: LLTClassification code 10051615Term: <Manually entered code. Term in E.1.1>

EUCTR2005-002942-20-DKsanofi-aventis recherche et developpement17,000

进行中（未招募）

不适用

EUCTR2005-002942-20-HUSanofi-Synthelabo Recherche17,000

进行中（未招募）

1 期

EUCTR2005-002942-20-GRsanofi-aventis recherche et developpement17,000

进行中（未招募）

不适用

EUCTR2005-002942-20-DESanofi-Aventis Recherche & Développement20,300