Non-Small Cell Lung CancerNCT07629375
Standardization of a Platform of Preclinical Models Derived From NSCLC Patients
An observational study of Non-Small Cell Lung Cancer, run by Regina Elena Cancer Institute at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- How many people
- 5 participants
- Where
- 1 siteItaly
- Study dates
- 24 Jul 2025to 24 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with untreated NSCLC who will undergo curative surgery
Who may be able to join
- 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).
Who cannot join
- Previous malignancies;
- Previous systemic treatments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS National Cancer Institute "Regina Elena"
Rome, Rome, 00144
Paola Nisticò, Medical Doctor, +39 06 52662539, paola.nisticò@ifo.it
About this study
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
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.
Read the 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.
- Conditions
- Non-Small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start24 Jul 2025
- Primary completion24 Apr 2026
- Study completion24 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Catanzaro
- Responsible party
- Sponsor
- Investigators
- Paola Nisticò, Medical Doctor, Principal investigator, IRCCS "Regina Elena" National Cancer Institude
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07629375
- Sponsor's protocol ID
- RS280/IRE/25
- Status last verified
- Jun 2026
- First submitted
- 18 Nov 2025
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07629375
- Acronym / sponsor ID
- RS280/IRE/25
- Conditions
- Non-Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Collaborators
- University of Catanzaro
- Study start
- 24 Jul 2025 (actual)
- Primary completion
- 24 Apr 2026 (actual)
- Study completion
- 24 Jul 2026 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with untreated NSCLC who will undergo curative surgery
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (2 listed)
- Previous malignancies;
- Previous systemic treatments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Efficacy of microencapsulated nutraceutical compounds.
Time frame: 9 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paola Nisticò, Medical Doctor principal investigator
IRCCS "Regina Elena" National Cancer Institude
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer, run by Regina Elena Cancer Institute at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paola Nisticò, Medical Doctor (+39 06 52662539, paola.nisticò@ifo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of microencapsulated nutraceutical compounds. (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.