CI

At a glance

ClinicalIndex Comparison Record
N/ARecruiting· 2,200 target
Drug / intervention
Not specified
Likely dose
Not stated in record
Key inclusion· 9
  • Age 18 years or older
  • ECOG performance status 0, 1, or 2
  • Histologically confirmed stage IIIB/C-IV NSCLC
  • Retrospective cohort: prior immunotherapy (including Durvalumab maintenance allowed)
Key exclusion· 3
  • Retrospective cohort: insufficient minimal treatment information data
  • Prospective cohort: prior treatment for advanced disease
  • Unable to comply with study procedures including QoL questionnaires

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05537922
NCT05537922N/ARecruitingUpdate OverdueUpdated 41mo ago · Completion was 9mo ago
Enrollment Stalled
Long Recruiting
Update Overdue

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

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano·observational·Posted Sep 13, 2022·Updated Jan 6, 2023

In Brief

An observational study for Non Small Cell Lung Cancer and 3 related conditions. Currently recruiting, targeting 2,200 participants across 4 sites in 4 countries.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Timeline

N/ARecruiting
20232024202520262027
First PostedSep 13, 2022
Enrollment StartOct 1, 2022
Primary CompletionOct 1, 2025
Study CompletionOct 1, 2027
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 3.8 years ago