Predicting responsiveness in oncology patients based on host response evaluation during anti cancer treatments

Target population 1. Patients with newly diagnosed stage IV NSCLC treated with Immunotherapy or Immunotherapy + Chemotherapy. 2. Patients with NSCLC stage IV treated with Immunotherapy at 2nd line or consecutive lines. 3. Patients with stage IV malignant melanoma treated with Immunotherapy with or without targeted therapy. 4. Patients with stage IIIb-d malignant melanoma treated with Immunotherapy as adjuvant therapy. 5. Patients with stage IV SCLC treated with Immunotherapy or Immunotherapy + Chemotherapy. Inclusion criteria 1. Provision of informed consent prior to any study-specific procedures. 2. Male or female aged at least 18 years. 3. ECOG PS – 0/1-2. 4. Normal hematologic, renal and liver function: • Absolute neutrophil count > 1500/mm3, platelets > 100,000/mm3, haemoglobin > 9 g/dL; • Creatinine concentration ≤ 1.4 mg/dL, or creatinine clearance > 40 mL/min; • Total bilirubin < 1.5 mg/dL, ALT+ AST levels ≤ 3 times above the upper normal limit. 5. The patient must have at least one measurable lesion and the relevant images in order to enable the assessment of the response.

1. Any concurrent and/or other active malignancy that has required systemic treatment within 2 years of first dose of study drug. 2. Generalized impairment or mental incompetence that would render the patient unable to understand his/her participation in the study.