Recruiting

Immunotherapy

Sponsor:

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Code:

NCT05537922

Conditions

Non Small Cell Lung Cancer

Lung Cancer Metastatic

Lung Cancer, Nonsmall Cell

Lung Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Non Small Cell Lung Cancer

Lung Cancer Metastatic

Lung Cancer, Nonsmall Cell

Lung Adenocarcinoma

Study ID

NCT05537922

Start date

Oct 1, 2022

Status verified date

Jan, 2023

Completion date

Oct 1, 2027

Anticipated

Primary completion date

Oct 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

2200 participants

Anticipated

Interventions and Outcome Measures

Arms

Retrospective Cohort

This cohort includes the analysis of a multicentric retrospective cohort of more than 2,000 patients. This cohort will be used to perform a preliminary knowledge extraction phase and to build a retrospective predictive model for IO (R-Model). All available clinical data will be collected. Also, CT and PET scans will be collected and a first radiomic signature.

Prospective Cohort

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.

Primary outcome measure

  • Response Rate [ Time Frame: 8 weeks (i.e. first radiological evaluation) ]

Central Contacts and Locations

Locations

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

More Information

Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Last update posted

Jan 6, 2023

Last verified

Jan, 2023

Keywords

  • NSCLC
  • Artificial Intelligence
  • Immunotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano on 2023-01-06.