This is a monocentric prospective observational study. This study will include patients with a diagnosis of non-small cell lung cancer for the collection of blood and tissue specimens.
Participant is willing and able to provide informed consent for participation in the study.
Age: Adults aged 18 years or older.
Diagnosis: non-small cell lung cancer (Stage I-II, III), with or without lymph node involvement, ideally with sufficient tumor burden to provide adequate tissue for analysis. In accordance with good clinical practice, patients with early-stage disease will undergo direct surgery, whereas patients with advanced-stage disease will receive neoadjuvant treatment followed by surgery.
Ability to attend scheduled follow-up visits, if applicable, for additional peripheral blood sample collection during treatment.
Presence of any active infection or underlying condition that could compromise the safety of tissue and blood sampling.
Prior history of another malignancy that might interfere with data interpretation related to non-small cell lung cancer progression and immune response.
Any current use of immunosuppressive medications (e.g., high-dose steroids) which might alter immune response assessments, except as part of non-small cell lung cancer treatment.
Pregnancy and breastfeeding
The study population includes adult patients diagnosed with non-small cell lung cancer. Individuals of diverse gender, age, and ethnicity will be included, specifically those with stage I-II and III non-small cell lung cancer, including cases with lymph node involvement.
Case-only
Prospective
Not listed
Frequency and cytotoxic activity of patient-specific tumor-reactive T cells.
The outcome will be evaluated by measuring the percentage of tumor-reactive T cells expressing activation markers (e.g., CD137, CD107a) via flow cytometry. Cytotoxic activity will be assessed through a tumor-killing assay, quantified as the percentage of tumor cell death measured by microscopy and flow cytometry.
Expression of activation, differentiation, and exhaustion markers in generated T cell product.
The outcome will be evaluated by measuring the percentage of T cells expressing activation (e.g., CD137, CD107a), differentiation (e.g., CD45RA, CCR7), and exhaustion (e.g., PD-1, TIM-3) markers via flow cytometry.
Time required for T cell generation and functional assessment.
The outcome will be evaluated by measuring the time (in days) required to generate tumor-reactive T cells and assessing their functionality through activation marker expression (e.g., CD137, CD107a) and cytotoxic activity via flow cytometry.
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Ospedale San Raffaele
Lead sponsor
Fondazione Umberto Veronesi
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
