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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione IRCCS Istituto Nazionale dei Tumori, Milano

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

2,200 Participants
are grouped into 2 trial groups

Sponsors and collaborators

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