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.
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 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
The retrospective cohort consists of aNSCLC patients treated with IO. Data from an estimated 2000 patients treated with IO-based therapy will be collected from all the clinical partners (INT, GHD, VHIO, MH, SZMC and UOC). Informed consent for the study will be obtained before enrolment. If not feasible, i.e. patients not alive, the approval to Privacy Guarantee will be obtained. In the prospective phase, the study cohort consists of aNSCLC patients candidate for first-line IO-based therapy with available surgical samples (enough to perform OMICs). Baseline data of an estimated 200 patients from 5 clinical centers (INT, GHD, VHIO, MH and SZMC) will be collected including complete clinical, multi- OMICs analysis, imaging of CT and PET scan at baseline IO, behavioral, health economic, QoL measurements with based-sensor techniques and standard QoL. Informed consent for the study will be obtained before enrolment.
Cohort
Other
Not listed
Response Rate
Prediction of response to immune checkpoint inhibitors in NSCLC
PFS
Progression Free Survival in NSCLC treated with immune checkpoint inhibitors
OS
Overall Survival in NSCLC treated with immune checkpoint inhibitors
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Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Lead sponsor
Vall d'Hebron Institute of Oncology
Collaborator
Shaare Zedek Medical Center
Collaborator
LungenClinic Grosshansdorf
Collaborator
Metropolitan Hospital, Athens
Collaborator
University of Chicago
Collaborator
