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

OncoHost

Status: Enrolling

Conditions: Healthy; Non Small Cell Lung Cancer

Treatments: Other: blood, stool and tissue samples collection

Study type: Observational

Funder types: Industry

Identifiers

NCT05736029

OH-HRPP-002

Details and patient eligibility

About

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.

Full 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)

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

350 participants in 3 patient groups

Non-operable NSCLC patients receiving ICI therapy

Description:

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

Treatment:

Other: blood, stool and tissue samples collection

Operable NSCLC Patients Receiving ICI as Neoadjuvant or Adjuvant Therapy

Description:

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

Treatment:

Other: blood, stool and tissue samples collection

Healthy volunteers

Description:

Sex and aged matched non-diseased volunteers

Treatment:

Other: blood, stool and tissue samples collection