An observational study in Carcinoma, Non-Small-Cell Lung, sponsored by Ospedale San Raffaele. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-10.
Sponsored by Ospedale San Raffaele · Observational
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.
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.
7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.
This study's planned enrollment of 20 is below the median of 160 across 1,148 observational studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Ospedale San Raffaele is the lead sponsor of 46 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult subjects with diagnosis of non-small cell lung cancer (NSLC) that could undergo surgery or neo-adjuvant treatment.
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.
Time frame: 1-30 months
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 frame: 12-30 months
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.
Time frame: 18-30 months
No study locations are listed for this record.
Plan to share: Undecided
This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung →
Ospedale San Raffaele