Predicting how well immunotherapy works for lung cancer patients
Builds a tool to predict immunotherapy response in adults with non-small cell lung cancer.
Plain-language title generated from the registry record
Registry title: I3LUNG: Integrative Science, Intelligent Data Platform for Individualized LUNG Cancer Care With Immunotherapy
Key facts
- Where
- Barcelona, SpainSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced non-small cell lung cancer (stage IIIB/C-IV) who got, or are about to get, immunotherapy.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Non-small cell lung cancer confirmed by tissue testing, stage IIIB/C-IV. Brain or spinal cord (CNS) metastases are allowed. ECOG performance status of 2 or lower.
- Earlier treatment
- Past-treatment group: has received immunotherapy of any line (Durvalumab maintenance is allowed). New-treatment group: a doctor plans immunotherapy as first treatment, with no prior treatment for advanced disease.
- Biomarker or test result
- Past-treatment group: people with driver gene changes can join. New-treatment group: needs at least one tumour tissue block (FFPE) for lab tests.
Main reasons for not taking part
- Past-treatment group: not enough treatment information available
- New-treatment group: any earlier treatment for advanced disease
- Cannot take part in the study procedures, such as quality-of-life questionnaires
Read by machine on 12 November 2026.
Where in Spain
- Vall d'Hebron Institute of OncologyBarcelona, SpainContact: Enriqueta FelipTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Trial code
- NCT05537922
- Record updated
- 6 January 2023
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Prior treatment for advanced disease (only for prospective cohort); Patients without minimal treatment information data to be included in the retrospective cohort; Unavailability or inability to comply with the requested study procedures, including compilation of QoL questionnaires.