An observational study in Nsclc, sponsored by Regina Elena Cancer Institute. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-09.
Sponsored by Regina Elena Cancer Institute · Observational
Prospective, biological, observational study involving the collection and use of samples from patients suffering from NSCLC lung cancer, aimed at comparing the molecular profile related to metabolism among subjects with response or resistance to checkpoint inhibitors immune system (ICI), in order to contribute to define response biomarkers and new molecular pathways as therapeutic targets combine with ICI to overcome resistance.
This study aims to identify the metabolic pathways related to the tumor microenvironment in NSCLC patients and their role in the response to ICI.
To this end, the metabolic picture will be evaluated on tumor-associated fibroblasts and macrophages tumor-associated and tumor-infiltrating lymphocytes, obtained from tissue samples of two different cohorts of patients candidate to receive immune-checkpoint treatment inhibitors. Furthermore it will correlate metabolic alterations in tumor tissues and peripheral immune cells or in plasma proteins of NSCLC patients with clinical response to ICIs.
For this purpose, serum/plasma and peripheral blood mononuclear cells (PBMC) will be isolated from the peripheral blood of patients to carry out phenotypic, metabolic and transcriptional studies on cells peripheral immune system. Finally it will come explored the therapeutic modulation of metabolic signatures identified in ex vivo models, using organoids and cultures of organotypic tissue sections obtained from patients affected by NSCLC, subjected to curative surgical treatment and treatment naive.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's planned enrollment of 150 is close to the median of 161 across 949 observational studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Regina Elena Cancer Institute is the lead sponsor of 92 studies on the registry; 50 are open to participants now.
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Patients suffering from NSCLC lung cancer
For the second cohort in addition to the precedents it is included
For the third cohort in addition to the precedents it is included
Exclusion Criteria:
For the second cohort
For the third cohort
Collection of sera/plasma from 400 patients, present in the Institute's Biobank. These are cells peripheral blood mononuclear cells (PBMC) and 150 tumor-infiltrating lymphocytes, cells immune cells that infiltrate adjacent non-tumor tissue and autologous CAFs from patients admitted to the IRE Institute for curative surgery. 20% of these patients relapse and access treatment Oncology Unit to be treated with immunotherapy according to the guidelines. This allows the availability on archive of tumor tissue, PBMC, CAF and TIL frozen at the time collected of the intervention who, at the time of progression, will begin treatment with ICIs according to clinical guidelines
Tissue taken will be collected, as per clinical practice, to curative surgery and when available to diagnostic biopsy. We plan to biobank in prospective manner: PBMC and plasma at the start of neoadjuvant treatment, the day before of surgery and during clinical follow-up with a pattern of every 3 months for at least 6 months of follow up and where possible up to 21 months. Evaluation of the response will be carried out by analysis of the pathological response in surgical tissue according to conventional criteria.
Collection of fresh tissue samples from treatment-naïve patients undergoing surgery for NSCLC. Which will be prospectively biobanked, particularly PBMC and day-ahead plasma of the surgery.
Overall survival OS
The application of spatial transcriptomic approaches will enable the discovery of specific cellular niches that may be responsible for mechanisms of sensitivity or resistance to ICI. With the results you get, you will probably have a chance to locate it new and wonderful metabolic pathways capable of exerting their anti-tumor effect even in combination with ICIs.
Time frame: 24 months
Plan to share: Undecided
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Regina Elena Cancer Institute