blood, stool and tissue samples collection: blood, stool and tissue samples collection before and during the treatment, as applicable
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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 outcome measure(s)
Overall response (OR) — month 3 OR as defined by RECIST 1.1 or any other validated clinical scale for response
Overall response (OR) — month 6 OR as defined by RECIST 1.1 or any other validated clinical scale for response
Overall response (OR) — month 9 OR as defined by RECIST 1.1 or any other validated clinical scale for response
Overall response (OR) — month 12 OR as defined by RECIST 1.1 or any other validated clinical scale for response
Overall response (OR) — month 15 OR as defined by RECIST 1.1 or any other validated clinical scale for response
Overall response (OR) — month 18 OR as defined by RECIST 1.1 or any other validated clinical scale for response
Overall response (OR) — month 21 OR as defined by RECIST 1.1 or any other validated clinical scale for response
Overall response (OR) — month 24 OR as defined by RECIST 1.1 or any other validated clinical scale for response
Plasma proteomic profile — Baseline, pre treatment Plasma proteins measurments
Plasma proteomic profile — 2(+/-1) weeks from first treatment Plasma proteins measurments
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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