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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:
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 -
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-operable NSCLC patients receiving ICI therapy | 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 | Patients with operable stage II-IIIA NSCLC, treated with immune check inhibitor in the neoadjuvant or adjuvant setting |
| |
| Healthy volunteers | Sex and aged matched non-diseased volunteers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood, stool and tissue samples collection | Other | blood, stool and tissue samples collection before and during the treatment, as applicable |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall response (OR) | OR as defined by RECIST 1.1 or any other validated clinical scale for response | month 3 |
| Overall response (OR) | OR as defined by RECIST 1.1 or any other validated clinical scale for response | month 6 |
| Overall response (OR) | OR as defined by RECIST 1.1 or any other validated clinical scale for response | month 9 |
| Overall response (OR) | OR as defined by RECIST 1.1 or any other validated clinical scale for response | month 12 |
| Overall response (OR) | OR as defined by RECIST 1.1 or any other validated clinical scale for response | month 15 |
| Overall response (OR) | OR as defined by RECIST 1.1 or any other validated clinical scale for response | month 18 |
| Overall response (OR) | OR as defined by RECIST 1.1 or any other validated clinical scale for response | month 21 |
| Overall response (OR) | OR as defined by RECIST 1.1 or any other validated clinical scale for response |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | Documentation of Progression Free Survival (PFS) duration | From date of enrollment until the date of first documented progression, assessed up to 100 months |
| Overall Survival (OS) |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Galit Yahalom, PhD | Contact | 97248537557 | galit@oncohost.com | |
| Shani Raveh Shoval, PhD | Contact | 97248537557 | shani@oncohost.com |
| Name | Affiliation | Role |
|---|---|---|
| Ronan J Kelly, MD MBA | Chief of Oncology Baylor Scott & White Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor Scott and White Research Institute | Recruiting | Dallas | Texas | 75204 | United States |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D003672 | Defecation |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| month 24 |
| Plasma proteomic profile | Plasma proteins measurments | Baseline, pre treatment |
| Plasma proteomic profile | Plasma proteins measurments | 2(+/-1) weeks from first treatment |
| Plasma proteomic profile | Plasma proteins measurments | 3 months |
| Plasma proteomic profile | Plasma proteins measurments | 6 months |
| Plasma proteomic profile | Plasma proteins measurments | 9 months |
| Plasma proteomic profile | Plasma proteins measurments | 12 months |
| Plasma proteomic profile | Plasma proteins measurments | 15 months |
| Plasma proteomic profile | Plasma proteins measurments | 18 months |
| Plasma proteomic profile | Plasma proteins measurments | 21 months |
| Plasma proteomic profile | Plasma proteins measurments | 24 months |
| Epigenetic patterns | Characterization of Cell free DNA | Baseline, pre treatment |
| Epigenetic patterns | Characterization of Cell free DNA | 2(+/-1) weeks from first treatment |
| Epigenetic patterns | Characterization of Cell free DNA | 12 months |
| Epigenetic patterns | Characterization of Cell free DNA | 24 months |
| ctDNA mutation analysis | ctDNA mutation analysis | immediately after surgery |
| Microbiome profiling | PBMC subpopulations exploration | Baseline, pre treatment |
| Microbiome profiling | PBMC subpopulations exploration | 2(+/-1) weeks from first treatment |
| Microbiome profiling | PBMC subpopulations exploration | 12 months |
| Microbiome profiling | PBMC subpopulations exploration | 24 months |
Documentaion of Overall Survival (OS) duration
| From date of enrollment until the date of death from any cause, assessed up to 100 month |
| Adverse Events (AE) | AE, as reported by the patients | 3 months |
| Adverse Events (AE) | AE, as reported by the patients | 6 months |
| Adverse Events (AE) | AE, as reported by the patients | 9 months |
| Adverse Events (AE) | AE, as reported by the patients | 12 months |
| Adverse Events (AE) | AE, as reported by the patients | 15 monthst |
| Adverse Events (AE) | AE, as reported by the patients | 18 months |
| Adverse Events (AE) | AE, as reported by the patients | 21 months |
| Adverse Events (AE) | AE, as reported by the patients | 24 months |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D004068 | Digestive System Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |