Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments
Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments
This study will develop an algorithm of identifying patients with stage IV NSCLC and Melanoma
 who could benefit from cancer treatment they receive.
The goal of this research study is to develop an algorithm that predicts the patient's
 treatment outcome.This algorithm will serve as a tool for physicians when making treatment
 decisions, specifically for stage IV NSCLC and malignant melanoma patients receiving
 anti-cancer treatments. The investigators also aim to identify the metabolic pathways that
 could lead to better therapeutic options. The patients will be given their treatment
 according to the institute's standard of care. The patients will provide two blood samples
 and clinical data will be collected from their medical records.

 In the first part of the trial, the data obtained from the blood samples and the medical
 records of the patients will be used to develop the prediction algorithm, and in the second
 part of the trial, the algorithm will be validated by comparing the objective response rate
 of the patients to the theoretical response prediction of the algorithm.
Inclusion Criteria:

 -  Cancer patients with stage IV NSCLC or stage IV malignant melanoma

 -  Patient must have at least one measurable lesion and the relevant images in order to
 enable assessment of response

 -  ECOG PS - 0/1-2

 -  Normal hematologic, renal and liver function:

 1. Absolute neutrophil count higher than 1500/mm3

 2. Platelets count higher than 100,000/mm3

 3. haemoglobin higher than 9 g/dL

 4. Creatinine concentration ≤1.4 mg/dL, or creatinine clearance higher than 40
 mL/min

 5. Total bilirubin lower than 1.5 mg/dL, ALT and AST levels ≤ 3 times above the
 upper normal limit.

 Exclusion Criteria:

 -  Concurrent and/or other active malignancy that has required systemic treatment within
 2 years of first dose of study drug

 -  Generalized impairment or mental incompetence that would render the patient unable to
 understand his/her participation in the study.