Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Patients with non-operable stage IIIB-IV NSCLC treated with immune check inhibitor anti cancer treatment as a standard of care

Patients with operable stage II-IIIA NSCLC, treated with immune check inhibitor in the neoadjuvant or adjuvant setting

Sex and aged matched non-diseased volunteers

blood, stool and tissue samples collection before and during the treatment, as applicable

blood, stool and tissue samples collection

Galit Yahalom, PhD

Shani Raveh Shoval, PhD

Pappu Himabindu

Ronan J Kelly, MD MBA

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.

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)

1. plasma samples
2. PBMCs
3. Stool samples
4. Tissue samples

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

PROPHETIC Extended - Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments, Extended Study.

Documentation of Progression Free Survival (PFS) duration

Documentaion of Overall Survival (OS) duration

OR as defined by RECIST 1.1 or any other validated clinical scale for response

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments, Using Multiomics	NCT05736029	Non Small Cell ... Healthy	blood, stool an...	18 Years -	OncoHost Ltd.
Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments, Using Multiomics	NCT05736029	Non Small Cell ... Healthy	blood, stool an...	18 Years -	OncoHost Ltd.
Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments, Using Multiomics	NCT05736029	Non Small Cell ... Healthy	blood, stool an...	18 Years -	OncoHost Ltd.

Spots Global Cancer Trial Database for blood, stool and tissue samples collection