Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments

Study Overview
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Brief Summary
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This study will develop an algorithm of identifying patients with stage IV NSCLC and Melanoma who could benefit from cancer treatment they receive.

Detailed Description
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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.

Official Title
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PROPHETIC - Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments

Conditions
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Stage IV Non-small Cell Lung Cancer, Stage IV Malignant Melanoma, Stage IV Small Cell Lung Cancer, Stage III Malignant Melanoma

Intervention / Treatment
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* Other: Plasma sample collection


Participation Criteria
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Eligibility Criteria
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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: Absolute neutrophil count higher than 1500/mm3 Platelets count higher than 100,000/mm3 haemoglobin higher than 9 g/dL Creatinine concentration ≤1.4 mg/dL, or creatinine clearance higher than 40 mL/min 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Newly diagnosed NSCLC stage IV<br>Patients with newly diagnosed stage IV NSCLC treated with Immunotherapy or Immunotherapy + Chemotherapy. | Other: Plasma sample collection<br>* Collect at least two plasma samples<br>|
| NSCLC stage IV 2nd line and further of immunotherapy<br>Patients with NSCLC stage IV treated with Immunotherapy at 2nd line or consecutive lines. | Other: Plasma sample collection<br>* Collect at least two plasma samples<br>|
| Malignant melanoma stage IV<br>Patients with stage IV malignant melanoma treated with Immunotherapy with or without targeted therapy. | Other: Plasma sample collection<br>* Collect at least two plasma samples<br>|
| Malignant melanoma stage IIIb-d<br>Patients with stage IIIb-d malignant melanoma treated with Immunotherapy as adjuvant therapy. | Other: Plasma sample collection<br>* Collect at least two plasma samples<br>|
| SCLC stage IV<br>Patients with stage IV SCLC treated with Immunotherapy or Immunotherapy + Chemotherapy. | Other: Plasma sample collection<br>* Collect at least two plasma samples<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate (ORR) at 3 months | ORR as defined by RECIST 1.1 or other validated method for ORR evaluation | At 3 months after therapy | 
| Overall response rate (ORR) at 6 months | ORR as defined by RECIST 1.1 or other validated method for ORR evaluation | At 6 months after therapy | 
| Changes in the blood levels of different proteins that represent the host response | Changes in Blood levels of proteins representing the Host response | At baseline (pre-therapy) and after 1st dose administration (post therapy) |