Characterize and trace innovative nutraceuticals based on microencapsulated resveratrol and Cynara cardunculus extract, using preclinical models such as organotypic tissue slices and tumoroids created from tumor fragments derived from patients with non-small cell lung cancer. This will enable the development of combination therapies to increase the efficacy of immunotherapy in NSCLC and reduce side effects that lead to treatment discontinuation.

The market implementation of these products may offer unique advantages, including increased clinical efficacy, improved tolerability of immune checkpoint inhibitors, reduced healthcare costs, improved quality of life for patients and their families, traceability of naturally derived products, and environmental sustainability.

Aimed at conducting research and development activities to characterize nutraceutical compounds with reduced environmental impact, increased bioavailability, and efficacy, including in cases of resistance to traditional anticancer therapies, thanks to innovative microencapsulation technology; the standardization of a platform of patient-derived organotypic models to evaluate the efficacy of new compounds, in combination with immunotherapy, in lung cancer; the implementation of advanced traceability models and products throughout the supply chain leading to the use of naturally derived products for human health.

Three different work packages conducted individually by the individual partners.

Specifically, the IRCCS Istituto Nazionale Tumori Regina Elena will lead and coordinate the activities related to the standardization of preclinical models derived from NSCLC patients to evaluate the efficacy of new nutraceutical compounds used as monotherapy or in combination with immunotherapies. In detail, the aim is to standardize and analyze with spatial transcriptomics a tissue slice and tumoroid platform to evaluate the efficacy of new microencapsulated nutraceutical compounds in combination with immunotherapy in patients with lung cancer. The prospective, non-pharmacological, biological pilot study involves the collection and use of samples from prospectively recruited patients affected by untreated non-small cell lung cancer who have undergone curative surgery at the Thoracic Oncology Unit of the Regina Elena Cancer Institute in Rome. Samples will be appropriately analyzed and will meet the inclusion criteria.

Inclusion criteria:

• Patients over 18 years of age;
• Patients diagnosed with resectable NSCLC who will undergo curative surgery;
• Patients who give written informed consent (study participation and data processing).

Exclusion criteria:

• Previous malignancies;
• Previous systemic treatments.

Patients with untreated NSCLC who will undergo curative surgery