Standardizing patient-derived models to test microencapsulated nutraceuticals with immunotherapy in NSCLC
Official title: 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
Run by Regina Elena Cancer Institute · NCT07629375 · Data updated 2026-11-12
Doctors will test microencapsulated nutraceuticals derived from resveratrol and artichoke extract in preclinical NSCLC models made from patients’ tumor tissue to see if they boost immunotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 5 (estimated) |
| Sponsor | Regina Elena Cancer Institute Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Rome, Rome) |
| Status | Recruiting |
| Started | July 24, 2025 |
| Main results expected | April 24, 2026 |
| Study ends | July 24, 2026 |
| Registry record updated | June 5, 2026 |
| Trial ID | NCT07629375 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with resectable NSCLC undergoing curative surgery who consent to tissue use and data processing.
✕Probably not a fit
Patients without resectable disease or whose tissue-derived models do not respond to the nutraceutical compounds may not experience direct benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational project standardizes a platform of patient-derived organotypic models, including tissue slices and tumoroids, to evaluate the efficacy of microencapsulated nutraceutical compounds alone and in combination with immunotherapies in NSCLC. It uses spatial transcriptomics to characterize responses in models derived from patients with resectable disease. The work is organized into three independent work packages led by IRCCS Istituto Nazionale Tumori Regina Elena and collaborators, focusing on model standardization, compound characterization, and translational traceability. The study collects specimens from untreated NSCLC patients undergoing curative surgery to inform future therapeutic strategies and product development. Interventions are non-pharmacological and experimental, centered on model-based testing rather than active patient treatment in this phase.
Why it matters
Potential benefit: If successful, patients could benefit from more effective and better-tolerated immunotherapy options in the future.
How similar studies have gone: Previous work with patient-derived models has shown promise for testing combination strategies, but this specific nutraceutical and traceability platform in NSCLC is novel.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
IRCCS National Cancer Institute "Regina Elena"
Rome, Rome, Italy Recruiting
Study contacts
- Principal investigator: Paola Nisticò, Medical Doctor — IRCCS "Regina Elena" National Cancer Institude
- Study coordinator: Paola Nisticò, Medical Doctor
- Email: paola.nisticò@ifo.it
- Phone: +39 06 52662539
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.