I3LUNG: Integrative Science, Intelligent Data Platform for Individualized LUNG Cancer Care With Immunotherapy

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.

NCT Number	NCT05537922
Lead Sponsor	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Collaborators: Vall d'Hebron Institute of Oncology, Shaare Zedek Medical Center, LungenClinic Grosshansdorf, Metropolitan Hospital, Athens, University of Chicago
Conditions	Non Small Cell Lung Cancer, Lung Cancer Metastatic, Lung Cancer, Nonsmall Cell, Lung Adenocarcinoma
Enrollment	2,200 participants
Start Date	2022-10-01
Primary Completion	2025-10-01 (estimated)
Study Completion	2027-10-01 (estimated)
Updated on ClinicalTrials.gov	2023-01-06