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

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.

Study Overview

• Status: Recruiting
• Conditions: Non-Small Cell Lung Cancer

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.

• Study Type: Observational
• Enrollment (Estimated): 5

Contacts and Locations

• Study Contact: Name: Paola Nisticò, Medical Doctor; Phone Number: +39 06 52662539; Email: paola.nisticò@ifo.it

Study Locations

• Italy
  • Rome
    • Rome, Rome, Italy, 00144
      • Recruiting
      • IRCCS National Cancer Institute "regina Elena"
      • Contact: Paola Nisticò, Medical Doctor; Phone Number: +39 06 52662539; Email: paola.nisticò@ifo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with untreated NSCLC who will undergo curative surgery

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with untreated non-small cell lung cancer; Patients with untreated non-small cell lung cancer who will undergo curative surgery at the Thoracic Oncology Unit of the Regina Elena Cancer Institute in Rome were prospectively recruited.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of microencapsulated nutraceutical compounds.	To 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.	9 months

Collaborators and Investigators

• Sponsor: Regina Elena Cancer Institute
• Collaborators: University of Catanzaro
• Investigators: Principal Investigator: Paola Nisticò, Medical Doctor, IRCCS "Regina Elena" National Cancer Institude

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2025
• Primary Completion (Actual): April 24, 2026
• Study Completion (Estimated): July 24, 2026

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: June 4, 2026
• First Posted (Actual): June 5, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: RS280/IRE/25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No