PROPHETIC Extended - Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments, Extended Study.
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)
Arms & interventions
- Otherblood, stool and tissue samples collection
blood, stool and tissue samples collection before and during the treatment, as applicable
Outcome measures
Primary
Overall response (OR)
OR as defined by RECIST 1.1 or any other validated clinical scale for response
Time frame: month 3
Overall response (OR)
OR as defined by RECIST 1.1 or any other validated clinical scale for response
Time frame: month 6
Overall response (OR)
OR as defined by RECIST 1.1 or any other validated clinical scale for response
Time frame: month 9
Overall response (OR)
OR as defined by RECIST 1.1 or any other validated clinical scale for response
Time frame: month 12
Overall response (OR)
OR as defined by RECIST 1.1 or any other validated clinical scale for response
Time frame: month 15
Overall response (OR)
OR as defined by RECIST 1.1 or any other validated clinical scale for response
Time frame: month 18
Overall response (OR)
OR as defined by RECIST 1.1 or any other validated clinical scale for response
Time frame: month 21
Overall response (OR)
OR as defined by RECIST 1.1 or any other validated clinical scale for response
Time frame: month 24
Plasma proteomic profile
Plasma proteins measurments
Time frame: Baseline, pre treatment
Plasma proteomic profile
Plasma proteins measurments
Time frame: 2(+/-1) weeks from first treatment
Plasma proteomic profile
Plasma proteins measurments
Time frame: 3 months
Plasma proteomic profile
Plasma proteins measurments
Time frame: 6 months
Plasma proteomic profile
Plasma proteins measurments
Time frame: 9 months
Plasma proteomic profile
Plasma proteins measurments
Time frame: 12 months
Plasma proteomic profile
Plasma proteins measurments
Time frame: 15 months
Plasma proteomic profile
Plasma proteins measurments
Time frame: 18 months
Plasma proteomic profile
Plasma proteins measurments
Time frame: 21 months
Plasma proteomic profile
Plasma proteins measurments
Time frame: 24 months
Epigenetic patterns
Characterization of Cell free DNA
Time frame: Baseline, pre treatment
Epigenetic patterns
Characterization of Cell free DNA
Time frame: 2(+/-1) weeks from first treatment
Epigenetic patterns
Characterization of Cell free DNA
Time frame: 12 months
Epigenetic patterns
Characterization of Cell free DNA
Time frame: 24 months
ctDNA mutation analysis
ctDNA mutation analysis
Time frame: immediately after surgery
Microbiome profiling
PBMC subpopulations exploration
Time frame: Baseline, pre treatment
Microbiome profiling
PBMC subpopulations exploration
Time frame: 2(+/-1) weeks from first treatment
Microbiome profiling
PBMC subpopulations exploration
Time frame: 12 months
Microbiome profiling
PBMC subpopulations exploration
Time frame: 24 months
Eligibility criteria
Study locations (1)
Baylor Scott and White Research Institute
Dallas, Texas, 75204