NCT05537922 · Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
I3LUNG: Integrative Science, Intelligent Data Platform for Individualized LUNG Cancer Care With Immunotherapy
What this study is about
I3LUNG is an international project aiming to develop a medical device to predict immunotherapy effectiveness for NSCLC patients using the integration of multisource data (real word and multi-omics data).
View original scientific description
I3LUNG is an international project aiming to develop a medical device to predict immunotherapy efficacy for NSCLC patients using the integration of multisource data (real word and multi-omics data). This objective will be reached through a retrospective - setting up a transnational platform of available data from 2000 patients - and a prospective - multi-omics prospective data collection in 200 NSCLS patients - study phase. The retrospective cohort will be used to perform a preliminary knowledge extraction phase and to build a retrospective predictive model for IO (R-Model), that will be used in the prospective study phase to create a first version of the PDSS tool, an AI-based tool to provide an easy and ready-to-use access to predictive models, increasing care appropriateness, reducing the negative impacts of prolonged and toxic treatments on wellbeing and healthcare costs. The prospective part of the project includes the collection and the analysis of multi-OMICs data from a multicentric prospective cohort of about 200 patients. This cohort will be used to validate the results obtained from the retrospective model through the creation of a new model (P-Model), which will be used to create the final PDSS tool.
Primary outcome measures
Response Rate
Time frame: 8 weeks (i.e. first radiological evaluation)
Prediction of response to immune checkpoint inhibitors in NSCLC
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Chicago, Illinois
Collaborators
Vall d'Hebron Institute of Oncology, Shaare Zedek Medical Center, LungenClinic Grosshansdorf, Metropolitan Hospital, Athens, University of Chicago
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 6, 2023 · Source of record for eligibility and locations