Non Squamous Non Small Cell Lung Cancer
Conditions
Interventions
Eligible patients will receive MB12 or Keytruda every 21 days for 52 weeks (up to 12 months).
Sponsors
Nishigaki Makoto
Eligibility
Sex/Gender
All
Inclusion 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
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. Replacement therapy (e.g., T4, insulin, or physiological corticosteroid replacement therapy for pituitary or adrenal insufficiency, etc.) is not considered a form of systemic treatment. 6. Contraindication and/or intolerance to the administration of pembrolizumab and excipients, or known sensitivity to any component of pembrolizumab and excipients (See Investigator Brochure and Keytruda SmPC for excipient details). 7. Has a known sensitivity to any component of cisplatin, carboplatin, or pemetrexed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Co-Primary Endpoints Primary PK endpoints: o Area under the concentration-time curve (AUC) between Cycle 1 and Cycle 2 (AUC from time 0 to 504 hours postdose [AUC0-504]) o AUC at steady state (AUCss) between Cycle 7 and Cycle 8 Primary efficacy endpoint: o Objective response rate (ORR), based on best ORR, up to and including 24 weeks (end of Cycle 8) as assessed by blinded independent central review (BICR) | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR as assessed by BICR at Weeks 6, 12, 18, 24, 33, 42, and 51 (end of Cycles 2, 4, 6, 8,11, 14, and 17, respectively) Progression-free survival (PFS) as assessed by BICR at Weeks 24 and 51 (end of Cycles 8 and 17, respectively) Duration of response (DOR) as assessed by BICR at Weeks 24 and 51 (end of Cycles 8 and 17, respectively) Overall survival (OS) at Weeks 24 and 51 (end of Cycles 8 and 17, respectively) Maximum concentration (Cmax) Time to maximum concentration (Tmax) Minimum concentration (Ctrough) Clearance (CL) Elimination half-life (t1/2) Distribution volume (Vd) Treatment-emergent adverse events (TEAEs), clinical laboratory tests (hematology, serum chemistry [including selected hormone panel], coagulation, and urinalysis), vital signs (systolic and diastolic blood pressure, pulse rate, oxygen saturation, respiratory rate, and body temperature), Eastern Cooperative Oncology Group (ECOG) performance status, 12-lead electrocardiogram (ECG) parameters, and physical examinations. Anti-drug antibodies (ADAs) Neutralizing antibodies (NAbs) in ADA-positive samples Titers in ADA-positive samples | — |
Countries
Japan, Moldova
Contacts
Public ContactKimio Morohoshi
Chemical Bio Research Inc.
Outcome results
None listed