Phase
Condition
N/ATreatment
MB12 (Proposed Pembrolizumab Biosimilar)
US-sourced Keytruda®
Carboplatin
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adult male/female patients ≥18 years old at the time of signing the informed consentform (ICF).
Histologic or cytologic diagnosis of advanced NSCLC, stage IV (defined by the 8thedition of the Tumor Node Metastasis [TNM] classification), with no EGFR sensitizing (activating) mutation or ALK translocation, and who have not received prior systemictreatment for metastatic NSCLC. In those patients in whom the pleural or pericardialeffusion is the only location of metastatic disease, confirmation of its malignantetiology is required.
At least 1 radiographically measurable lesion according to response evaluationcriteria in solid tumors (RECIST) 1.1.
Known status of PD-L1 expression.
Performance based on the Eastern Cooperative Oncology Group (ECOG) performancestatus ≤1.
Adequate hepatic, renal, hematologic, endocrine, and coagulation function.
Exclusion
Exclusion Criteria:
Predominantly squamous cell histology NSCLC. Mixed tumors will be categorized by thepredominant cell type; if small cell elements are present, the patient is noteligible.
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, oranti-cytotoxic T lymphocyte associated protein (CTLA)-4 therapy (includingipilimumab or any other antibody or drug that specifically targets co-stimulation ofT-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 knownsensitivity to any component of pembrolizumab.
Has a known sensitivity to any component of cisplatin, carboplatin, or pemetrexed.
Study Design
Connect with a study center
Site 108004
Batumi,
GeorgiaActive - Recruiting
Site 108005
Kutaisi,
GeorgiaActive - Recruiting
Site 108011
Marneuli,
GeorgiaActive - Recruiting
Site 108002
Tbilisi,
GeorgiaActive - Recruiting
Site 108003
Tbilisi,
GeorgiaActive - Recruiting
Site 108006
Tbilisi,
GeorgiaActive - Recruiting
Site 108007
Tbilisi,
GeorgiaActive - Recruiting
Site 108009
Tbilisi,
GeorgiaActive - Recruiting
Site 207002
Hakodate-shi,
JapanActive - Recruiting
Site 207012
Okayama-shi,
JapanActive - Recruiting
Site 207010
Shinagawa-Ku,
JapanActive - Recruiting
Site 27010
Shinagawa-Ku,
JapanActive - Recruiting
Site 207001
Shizuoka-shi,
JapanActive - Recruiting
Research site 116001
Chisinau,
Moldova, Republic ofActive - Recruiting
Site 121001
Belgrade,
SerbiaActive - Recruiting
Site 121002
Belgrade,
SerbiaActive - Recruiting
Site 1201003
Kragujevac,
SerbiaActive - Recruiting
Site 121003
Kragujevac,
SerbiaActive - Recruiting
Site 121004
Sremska Kamenica,
SerbiaActive - Recruiting
Site 121005
Užice,
SerbiaActive - Recruiting
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