Healthy, Non Small Cell Lung Cancer
Conditions
Brief summary
The goal of this exploratory study is understand the mechanisms of response to immunotherapy in Non-Small Cell Lung Cancer patients. The investigators are going to search for correlation between specific biological features and response to immunotherapy, and to use those associations for developing an algorithm enabling to identify patients that could benefit from the immune check inhibitor based anti cancer treatment. Patients will provide biological samples before and during their treatment, and clinical data will be collected.
Detailed description
The goal of the study is to develop an algorithm that associates between biomarkers detected in biospecimen of NSCLC patients, and their: * Response to treatment * Clinical benefit parameters such as PFS and OS. * Adverse events to immune check inhibitor therapy * Biological mechanisms involved in response or resistance to immune check inhibitor therapy. Patients will provide plasma, PBMCs, stool and tissue samples (where applicable) before and during treatment. Clinical data, including disease history, given treatment, response evaluation and adverse events to the treatment will be recorded. Samples will be analysed as follows - * Proteomic features (Plasma proteomics) * Epigenetic patterns (cell free DNA) * ctDNA mutation analysis * PBMC subpopulations * Microbiome profiling (Stool)
Interventions
OTHERblood, stool and tissue samples collection
blood, stool and tissue samples collection before and during the treatment, as applicable
Sponsors
OncoHost Ltd.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Exclusion criteria
* Any concurrent and/or other active malignancy that has required systemic treatment within 2 years of first dose of treatment. * 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 |
|---|---|---|
| Microbiome profiling | Baseline, pre treatment | PBMC subpopulations exploration |
| Plasma proteomic profile | Baseline, pre treatment | Plasma proteins measurments |
| Epigenetic patterns | Baseline, pre treatment | Characterization of Cell free DNA |
| ctDNA mutation analysis | immediately after surgery | ctDNA mutation analysis |
| Overall response (OR) | month 3 | OR as defined by RECIST 1.1 or any other validated clinical scale for response |
Other
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | From date of enrollment until the date of death from any cause, assessed up to 100 month | Documentaion of Overall Survival (OS) duration |
| Adverse Events (AE) | 3 months | AE, as reported by the patients |
| Progression Free Survival (PFS) | From date of enrollment until the date of first documented progression, assessed up to 100 months | Documentation of Progression Free Survival (PFS) duration |
Countries
United States
Contacts
Primary ContactGalit Yahalom, PhD
Backup ContactShani Raveh Shoval, PhD
Outcome results
None listed