Stage IIIb-d Malignant Melanoma, Stage III Unresectable Non-Small Cell Lung Cancer, Stage IV Malignant Melanoma, Stage IV Non-small Cell Lung Cancer, Stage IV Small Cell Lung Cancer
Conditions
Keywords
Non-small Cell Lung Cancer, Small Cell Lung Cancer, Malignant Melanoma
Brief summary
The PROPHETIC study is a prospective, multi-center, international clinical study aimed at developing an algorithm to predict patient outcomes. The study involves analyzing the proteomic profiles of patients undergoing therapy to assess the likelihood of clinical benefit from their prescribed treatment. Blood samples are collected prior to and during the treatment period and analyzed as part of the ongoing development of thealgorithm.
Detailed description
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.
Interventions
OTHERPlasma sample collection
Collect at least two plasma samples
Sponsors
OncoHost Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provision of informed consent prior to any study-specific procedures. * Male or female aged at least 18 years. * 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. * At least one measurable lesion in order to enable the assessment of the response (except for stage IIIb-d malignant melanoma patients).
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measured biological features at baseline (pre-treatment) and after 1st dose administration (on-treatment) and during treatment (optional) | Measured biological features are analyzed in samples taken at baseline (prior treatment) and after the 1st dose administration (on-treatment) and during treatment (optional) | Biological features are analyzed in biological samples taken from the patients as part of the study |
| Overall response as determined by RECIST 1.1 or any other validated clinical scales for response, every 3 months or according to the standard of care | Every 3 months or according to the standard of care | Overall response as determined by RECIST 1.1 or any other validated clinical scales for response, every 3 months or according to the standard of care |
| Progression Free Survival (PFS) | At progression during treatment | Collect Progression Free Survival (PFS) dates |
| Overall survival or last follow-up | Overall survival or last follow-up | Collect overall survival or last follow-up dates |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events (AE) | Adverse events (AE) during treatment and until the end of study | AE to treatment, as reported by the patient |
Countries
Germany, Israel, Spain, United Kingdom, United States
Outcome results
None listed