Integrative platform for personalized lung cancer care using AI
Official title: I3LUNG: Integrative Science, Intelligent Data Platform for Individualized LUNG Cancer Care With Immunotherapy
Run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · NCT05537922 · Data updated 2026-11-12
This study is trying to create a smart tool that helps doctors predict how well immunotherapy will work for people with non-small cell lung cancer, so they can make better treatment choices.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 2200 (estimated) |
| Sponsor | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Academic / other |
| Drugs / interventions | Durvalumab, immunotherapy |
| Locations | 4 sites (Chicago, Illinois and 3 other locations) |
| Status | Recruiting |
| Started | October 1, 2022 |
| Main results expected | October 1, 2025 |
| Study ends | October 1, 2027 |
| Registry record updated | January 6, 2023 |
| Trial ID | NCT05537922 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with stage IIIB/C-IV NSCLC who have received immunotherapy.
✕Probably not a fit
Patients with early-stage lung cancer or those who have not received any form of immunotherapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
I3LUNG is an international initiative focused on developing a medical device that predicts the efficacy of immunotherapy for patients with non-small cell lung cancer (NSCLC) by integrating diverse data sources, including real-world and multi-omics data. The project consists of a retrospective phase involving data from 2000 patients to create a predictive model, followed by a prospective phase that collects multi-omics data from 200 NSCLC patients. The aim is to enhance personalized medicine through AI and machine learning, ultimately leading to the creation of a user-friendly decision support tool for clinicians and patients. This tool will help in making informed treatment decisions while minimizing the negative impacts of prolonged therapies.
Why it matters
Potential benefit: If successful, this project could significantly improve treatment personalization for NSCLC patients, leading to better outcomes and reduced side effects.
How similar studies have gone: Other studies utilizing AI and multi-omics approaches in cancer treatment have shown promise, indicating potential success for this novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>/= 18 years. * Eastern Cooperative Oncology Group (ECOG) performance status \</= 2. * Histologically confirmed diagnosis of stage IIIB/C-IV Non-Small-Cell Lung Cancer * Received any line immunotherapy (maintenance therapy with Durvalumab is allowed) for retrospective cohort; clinical indication for frontline treatment with immunotherapy as first line treatment for prospective cohort. * Patients with CNS metastasis are allowed * Patients with driver genomic alterations are allowed (only for retrospective cohort) * Evidence of a personally signed and dated ICF indicating that the patient has been informed of and understands all pertinent aspects of the study before enrolment (only for prospective cohort) * Availability of at least one FFPE block for -omics data generation (only for prospective cohort) Exclusion Criteria: * Patients without minimal treatment information data to be included in the retrospective cohort * Prior treatment for advanced disease (only for prospective cohort) * Unavailability or inability to comply with the requested study procedures, including compilation of QoL questionnaires
Where it's running
-
University of Chicago
Chicago, Illinois, United States Recruiting -
Metropolitan Hospital
Athens, Greece Recruiting -
Shaare Zedek Medical Center
Jerusalem, Israel Recruiting -
Vall D'Hebron Institute of Oncology
Barcelona, Spain Recruiting
Study contacts
- Study coordinator: Arsela Prelaj, MD
- Email: arsela.prelaj@istitutotumori.mi.it
- Phone: +39 022390 3647
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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.