I3LUNG: Integrative Science, Intelligent Data Platform for Individualized LUNG Cancer Care With Immunotherapy
Trial ID: NCT05537922
Status: RECRUITING
Study type: OBSERVATIONAL
Start date: 2022-10-01
Completion date: 2027-10-01
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
Locations: University of Chicago; Metropolitan Hospital; Shaare Zedek Medical Center; Vall D'Hebron Institute of Oncology
Countries: United States; Greece; Israel; Spain
Enrollment: 2200
Age range: 18 Years - None
Sex: ALL

Summary:
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:
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

Outcomes:
Response Rate