Carcinoma, Non-Small-Cell Lung
Conditions
Keywords
Immunotherapy, Precision Oncology, Lung cancer, Adoptive Cell Transfer
Brief summary
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.
Detailed description
This study seeks to advance patient-specific cancer immunotherapy, through the ex-vivo generation of tumor-specific T cells recognizing and targeting tumor-specific mutations. The study will enroll 20 adult patients with a diagnosis of non-small cell lung cancer, including those with lymph node involvement. Biological samples, including tumor and healthy lung tissue, as well as peripheral blood, will be collected pre-surgery and pre-treatment. The establishment of this sample collection will enable the detailed study of tumor-specific immune responses in non-small cell lung cancer.
Interventions
None listed
Sponsors
Fondazione Umberto Veronesi
Ospedale San Raffaele
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency and cytotoxic activity of patient-specific tumor-reactive T cells. | 1-30 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Expression of activation, differentiation, and exhaustion markers in generated T cell product. | 12-30 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time required for T cell generation and functional assessment. | 18-30 months | 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. |
Contacts
Primary ContactChiara M Cattaneo, PhD
Outcome results
None listed