Clinical trial NCT05736029: Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments, Using Multiomics
Official title: PROPHETIC Extended - Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments, Extended Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non Small Cell Lung Cancer
Healthy
Lead sponsor: OncoHost Ltd.
Sponsor class: INDUSTRY
First posted: 2023-02-21
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population comprises 3 sub-populations:

Cohort 1 - Non-operable NSCLC (Stages IIIB to IV), receiving immune-check inhibitor (ICI) therapy \[any combination of ICI / ICI ±Chemotherapy, and any line of treatment\].

Cohort 2 - Operable NSCLC (Stages II-IIIA), receiving ICI in the neoadjuvant or adjuvant setting.

Cohort 3 - Sex and aged matched non-diseased volunteers.

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)

Eligibility criteria: 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.

Primary outcomes:
measure: Overall response (OR)
timeFrame: month 3
measure: Overall response (OR)
timeFrame: month 6
measure: Overall response (OR)
timeFrame: month 9
measure: Overall response (OR)
timeFrame: month 12
measure: Overall response (OR)
timeFrame: month 15
measure: Overall response (OR)
timeFrame: month 18
measure: Overall response (OR)
timeFrame: month 21
measure: Overall response (OR)
timeFrame: month 24
measure: Plasma proteomic profile
timeFrame: Baseline, pre treatment
measure: Plasma proteomic profile
timeFrame: 2(+/-1) weeks from first treatment
measure: Plasma proteomic profile
timeFrame: 3 months
measure: Plasma proteomic profile
timeFrame: 6 months
measure: Plasma proteomic profile
timeFrame: 9 months
measure: Plasma proteomic profile
timeFrame: 12 months
measure: Plasma proteomic profile
timeFrame: 15 months
measure: Plasma proteomic profile
timeFrame: 18 months
measure: Plasma proteomic profile
timeFrame: 21 months
measure: Plasma proteomic profile
timeFrame: 24 months
measure: Epigenetic patterns
timeFrame: Baseline, pre treatment
measure: Epigenetic patterns
timeFrame: 2(+/-1) weeks from first treatment
measure: Epigenetic patterns
timeFrame: 12 months
measure: Epigenetic patterns
timeFrame: 24 months
measure: ctDNA mutation analysis
timeFrame: immediately after surgery
measure: Microbiome profiling
timeFrame: Baseline, pre treatment
measure: Microbiome profiling
timeFrame: 2(+/-1) weeks from first treatment
measure: Microbiome profiling
timeFrame: 12 months
measure: Microbiome profiling
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
measure: Progression Free Survival (PFS)
timeFrame: From date of enrollment until the date of first documented progression, assessed up to 100 months
measure: Overall Survival (OS)
timeFrame: From date of enrollment until the date of death from any cause, assessed up to 100 month
measure: Adverse Events (AE)
timeFrame: 3 months
measure: Adverse Events (AE)
timeFrame: 6 months
measure: Adverse Events (AE)
timeFrame: 9 months
measure: Adverse Events (AE)
timeFrame: 12 months
measure: Adverse Events (AE)
timeFrame: 15 monthst
measure: Adverse Events (AE)
timeFrame: 18 months
measure: Adverse Events (AE)
timeFrame: 21 months
measure: Adverse Events (AE)
timeFrame: 24 months
Locations:
city: Dallas
country: United States
facility: Baylor Scott and White Research Institute
state: Texas
Study officials:
affiliation: Chief of Oncology Baylor Scott & White Health System
name: Ronan J Kelly, MD MBA
role: PRINCIPAL_INVESTIGATOR
References: