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Compares treatment options for Non Small Cell Lung Cancer Metastatic
Official title Double-blind Study to Evaluate the PK, Efficacy, Safety and Immunogenicity of MB12 Versus Keytruda® in Stage IV NSCLC
ClinicalTrials.gov ID: NCT05668650
What this study is testing
What is Pembrolizumab?
Pembrolizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non small cell lung cancer metastatic.
Also referred to as Keytruda.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a randomized, multicenter, multinational, double-blind, and parallel-group study to evaluate the PK, efficacy, safety and immunogenicity of MB12 (proposed pembrolizumab biosimilar) versus Keytruda® in subjects with newly diagnosed stage IV non-squamous NSCLC. This study is planned to be conducted in approximately 48 sites in 7 countries, a total of 174 subjects will be enrolled.
- Phase 3: a large, late-stage study
- Time commitment: about 16 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Individuals must meet all of the following criteria to be included in the study:
- 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.
- Body weight ≥50 kg at Screening.
- Having newly diagnosed stage IV (defined by the eighth edition of the TNM classification) non-squamous NSCLC, without prior systemic treatment for...
You likely can't join if
- 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...
- Participation in another clinical trial or treatment with another investigational agent within 4 weeks or 5 half-lives before randomization...
- 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...
See the full eligibility criteria
Who can join
- Individuals must meet all of the following criteria to be included in the study:
- 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.
- Body weight ≥50 kg at Screening.
- 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 people in whom the pleural or pericardial...
- At least 1 radiographically measurable lesion per RECIST version 1.1, locally assessed.
- Programmed death-ligand 1 (PD-L1) expression ≥50%, locally determined by immunohistochemistry, as determined by a Food and Drug Administration (FDA) validated method.
- Life expectancy of at least 3 months.
- ECOG performance status of 0 to 1.
- Adequate hepatic, renal, hematologic, endocrine, and coagulation function, defined as:
- Liver function: bilirubin level ≤1.5 × the upper limit of normal (ULN) (≤3 × ULN for people with Gilbert's syndrome), albumin level ≥ lower limit of normal (LLN), aspartate aminotransferase (AST)/alanine...
- Renal function: serum creatinine level ≤1.5 × ULN, calculated creatinine clearance ≥50 mL/min (Cockcroft-Gault formula).
- Hematologic function: absolute neutrophil count ≥1.5 × 109/L; platelet count ≥100 × 109/L, hemoglobin ≥9 g/dL.
- Endocrine function: thyroid stimulating hormone (TSH) within normal limits. If TSH is not within normal limits, the subject may still be eligible if T3 and free T4 are within normal limits.
- Coagulation: international normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN unless subject is receiving anticoagulant therapy. people on anticoagulant therapy must be on a stable...
- people 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...
- 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...
- Women of childbearing potential (WOCBP) must either abstain from sexual intercourse or employ highly effective contraception measures during the study and for at least 6 months after the last dose of the study drug...
- Male people, 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...
What rules you out
- 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. people receiving daily...
- 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...
- 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...
- 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...
- Interstitial lung disease or pneumonitis requiring oral or intravenous steroids.
- Active infection or a previous infection requiring intravenous systemic treatment within 30 days before the first dose of the study drug.
- Subject who has received or is about to receive a live virus vaccination within 30 days before the first dose of the study drug. Seasonal flu and COVID-19 vaccines that do not contain live virus are permitted.
- Known history of human immunodeficiency virus (HIV)-1 or HIV-2.
- Known active tuberculosis or hepatitis B (hepatitis B surface antigen [HBsAg] positive) or hepatitis C (hepatitis C antibody positive and hepatitis C virus [HCV] RNA positive).
- Subject who has received a solid organ/tissue allogeneic transplant.
- Known psychiatric disorders that could interfere with cooperation with study requirements.
- At the time of signing the ICF, the subject is a regular user (including "recreational use") of any illicit drug or has a recent history (within the past year) of substance abuse (including alcohol).
- Subject is pregnant or lactating or expecting to conceive during the study or up to 120 days after the last dose of the study drug.
- Immediate family member who is at the research site or sponsoring staff who is directly involved in this study
The study team makes the final eligibility decision.
Where it's taking place
- Viedma, Río Negro Province, Argentina
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 16 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Viedma, Río Negro Province, Argentina. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.