NCT05537922

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,200

participants targeted

Target at P75+ for all trials

Timeline
17mo left

Started Oct 2022

Longer than P75 for all trials

Geographic Reach
4 countries

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Oct 2022Oct 2027

First Submitted

Initial submission to the registry

September 5, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 13, 2022

Completed
18 days until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Expected
Last Updated

January 6, 2023

Status Verified

January 1, 2023

Enrollment Period

3 years

First QC Date

September 5, 2022

Last Update Submit

January 5, 2023

Conditions

Non Small Cell Lung CancerLung Cancer MetastaticLung Cancer, Nonsmall CellLung Adenocarcinoma

Keywords

NSCLCArtificial IntelligenceImmunotherapy

Outcome Measures

Primary Outcomes (1)

  • Response Rate

    Prediction of response to immune checkpoint inhibitors in NSCLC

    8 weeks (i.e. first radiological evaluation)

Secondary Outcomes (2)

  • PFS

    From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months

  • OS

    From date of enrollment until the date of death from any cause, assessed up to 120 months

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The retrospective cohort consists of aNSCLC patients treated with IO. Data from an estimated 2000 patients treated with IO-based therapy will be collected from all the clinical partners (INT, GHD, VHIO, MH, SZMC and UOC). Informed consent for the study will be obtained before enrolment. If not feasible, i.e. patients not alive, the approval to Privacy Guarantee will be obtained. In the prospective phase, the study cohort consists of aNSCLC patients candidate for first-line IO-based therapy with available surgical samples (enough to perform OMICs). Baseline data of an estimated 200 patients from 5 clinical centers (INT, GHD, VHIO, MH and SZMC) will be collected including complete clinical, multi- OMICs analysis, imaging of CT and PET scan at baseline IO, behavioral, health economic, QoL measurements with based-sensor techniques and standard QoL. Informed consent for the study will be obtained before enrolment.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Metropolitan Hospital

Athens, Greece

RECRUITING

Shaare Zedek Medical Center

Jerusalem, Israel

RECRUITING

Vall D'Hebron Institute of Oncology

Barcelona, Spain

RECRUITING

Related Publications (1)

  • Lo Russo G, Prelaj A, Dolezal J, Beninato T, Agnelli L, Triulzi T, Fabbri A, Lorenzini D, Ferrara R, Brambilla M, Occhipinti M, Mazzeo L, Provenzano L, Spagnoletti A, Viscardi G, Sgambelluri F, Brich S, Miskovic V, Pedrocchi ALG, Trovo' F, Manglaviti S, Giani C, Ambrosini P, Leporati R, Franza A, McCulloch J, Torelli T, Anichini A, Mortarini R, Trinchieri G, Pruneri G, Torri V, De Braud F, Proto C, Ganzinelli M, Garassino MC. PEOPLE (NTC03447678), a phase II trial to test pembrolizumab as first-line treatment in patients with advanced NSCLC with PD-L1 <50%: a multiomics analysis. J Immunother Cancer. 2023 Jun;11(6):e006833. doi: 10.1136/jitc-2023-006833.

    PMID: 37286305DERIVED

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungAdenocarcinoma of Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Central Study Contacts

Arsela Prelaj, MD

CONTACT

+39 022390 3647arsela.prelaj@istitutotumori.mi.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 5, 2022

First Posted

September 13, 2022

Study Start

October 1, 2022

Primary Completion

October 1, 2025

Study Completion (Estimated)

October 1, 2027

Last Updated

January 6, 2023

Record last verified: 2023-01

Locations

ES(1)GR(1)IL(1)US(1)