Table 3 Inclusion and exclusion criteria
Criteria | Details |
|---|---|
Inclusion criteria | • Histologically or cytologically-confirmed metastatic NSCLC (stage IV) |
• ≥18 years of age | |
• Presence of at least one tumor lesion ≥ 2 cm in size that is eligible for radiation and at least one additional measurable tumor lesion according to RECIST Ver 1.1 | |
• ECOG performance status 0 to 1 | |
• Adequate organ function: hemoglobin ≥95 g/L, platelet count ≥75000/μL, white blood cell count ≥2000/μL, absolute neutrophil count ≥1000/μL, lymphocyte count ≥0.8 × 109/L, ALT and AST ≤2.5 times ULN in patients without liver metastases and ≤5 times ULN in patients with liver metastases, serum creatinine ≤2 mg/dL, creatinine clearance ≥45 mL/min according to MDRD formula | |
Exclusion criteria | • Previous active immunotherapy for NSCLC (including vaccination, therapy with anti-CTLA4 antibodies) |
• Treatment with any investigational product in the 4 weeks prior to study entry | |
• Need for immunosuppressive treatment | |
• Active skin disease not allowing intradermal injections into areas of healthy skin for vaccine injection (for stratum 3 patients: persisting grade 3 skin rash at time of enrollment) | |
• Inadequate lung function dependent on the intended tumor volume and location to be irradiated (for patient planned to undergo radiation of thoracic lesions) | |
• Prior splenectomy or allogeneic bone marrow transplantation; history of pneumonitis, encephalitis or multiple sclerosis; active inflammatory conditions or autoimmune disorders (except for vitiligo, diabetes mellitus type 1 or autoimmune thyroiditis requiring hormone replacement only), primary or secondary immune deficiency, seropositivity for HIV, HBV, HCV or any other infection requiring anti-infection therapy; known brain metastases (except for stable metastases being treated with stereotactic radiation or surgery) | |
• Uncontrolled medical condition considered as high risk for the treatment with an investigational drug, unstable angina pectoris/myocardial infarction within the previous 6 months, significant cardiac arrhythmia, stroke or transient ischemic attack within the previous 6 months, severe hypertension according to WHO criteria, uncontrolled systolic blood pressure ≥180 mmHg | |
• Estimated life expectancy ≤3 months | |
• Unable to consent or comply with protocol | |
• Allergies to any components of the study drug | |
• Pregnancy or breast feeding | |
• Concurrent or planned major surgery or likelihood of requiring treatment with drugs not permitted by the clinical study protocol |