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Standardization of a Platform of Preclinical Models Derived From NSCLC Patients

Standardization of a Platform of Preclinical Models Derived From NSCLC Patients to Investigate the Efficacy of New Nutraceutical Compounds Used as Monotherapy or in Combination With Immunotherapeutics or Chemo-immunotherapy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07629375
Enrollment
5
Registered
2026-06-05
Start date
2025-07-24
Completion date
2026-07-24
Last updated
2026-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Regina Elena Cancer Institute
Lead SponsorOTHER
University of Catanzaro
CollaboratorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Efficacy of microencapsulated nutraceutical compounds.9 monthsTo investigate the efficacy of novel microencapsulated nutraceutical compounds in combination with immunotherapy in patients with lung cancer. Efficacy is measured as directly proportional to the binding created between the drug and the receptor.

Countries

Italy

Contacts

CONTACTPaola Nisticò, Medical Doctor
paola.nisticò@ifo.it+39 06 52662539
PRINCIPAL_INVESTIGATORPaola Nisticò, Medical Doctor

IRCCS "Regina Elena" National Cancer Institude

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 6, 2026