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

Recruiting

• Conditions: Non Small Cell Lung Cancer; Healthy
• Interventions: Other: blood, stool and tissue samples collection

• Registration Number: NCT05736029
• Lead Sponsor: OncoHost Ltd.

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)

Study Timeline

• Study Start: 2022-11-07
• Study First Submitted: 2023-01-31
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-09
• Last Update Submitted: 2023-02-09
• Study First Posted: 2023-02-21
• Last Update Posted: 2023-02-21
• Primary Completion: 2028-01-01
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 350

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-operable NSCLC patients receiving ICI therapy	blood, stool and tissue samples collection	Patients with non-operable stage IIIB-IV NSCLC treated with immune check inhibitor anti cancer treatment as a standard of care
Operable NSCLC Patients Receiving ICI as Neoadjuvant or Adjuvant Therapy	blood, stool and tissue samples collection	Patients with operable stage II-IIIA NSCLC, treated with immune check inhibitor in the neoadjuvant or adjuvant setting
Healthy volunteers	blood, stool and tissue samples collection	Sex and aged matched non-diseased volunteers

Primary Outcome Measures

Name	Time	Method
ctDNA mutation analysis	immediately after surgery	ctDNA mutation analysis
Plasma proteomic profile	24 months	Plasma proteins measurments
Epigenetic patterns	24 months	Characterization of Cell free DNA
Microbiome profiling	24 months	PBMC subpopulations exploration
Overall response (OR)	month 24	OR as defined by RECIST 1.1 or any other validated clinical scale for response

Trial Locations

Locations (1)

Baylor Scott and White Research Institute; 🇺🇸 Dallas, Texas, United States