AI-HOPE Lung Cancer: Building a Predictive Tool for Metastatic Lung Cancer

January 20, 2025 updated by: Francesca Rita Ogliari, IRCCS San Raffaele

The goal of our project is building a predictive response algorithm for patients with metastatic lung cancer, exploiting an artificial intelligence platform. It will collect patient information from all areas (clinical, laboratory, radiological, pathological) and analyse them, understanding connections and correlations, both at baseline and at pre-specified timepoints. It would lead to the development of a reliable and constantly evolving predictive score, able to continuously re-weight the importance of each variable as new data come in.

Since the greatest clinical need is identifying non-responders to immunotherapy and chemo-immunotherapy combination (30% of all treated patients), these two populations are defined as the starting cohorts (Cohort A, immunotherapy alone, Cohort B, chemo-immunotherapy combinations).

For each cohort, three main questions are to be answered:

Q1) Early progressors (defined as progressive disease or death within three months of treatment or at first radiological restaging) Q2) Toxicity (with a special focus on severe toxicities G≥3) Q3) Long survivors (defined as patients reaching an overall survival of at least 1.5x median overall survival in registrative trials)

The early identification of non-responders, high-risk patients (or on the other hand, long survivors) would help their healthcare planning, providing individualised follow-up strategies or prompting their inclusion in alternative treatments (eg clinical trials).

For all cohorts, first data entry will be retrospective and second data entry will be prospective (as validation set).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Milan, Italy, 20132
        • Recruiting
        • Francesca Rita Ogliari
        • Contact:
        • Principal Investigator:
          • Francesca Rita Ogliari

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with NSCLC stage IV treated with at least 1 cycle of first-line treatment

Description

Inclusion criteria:

  • Patients with histological or cytological diagnosis of NSCLC
  • Stage IV according to investigator's staging procedures (or any locally advanced tumour not feasible for local radical treatment)
  • Treatment with at least 1 cycle of mono-immunotherapy or chemo-immunotherapy (as per clinical practice)
  • Availability of follow-up

Exclusion criteria:

  • Patients with other thoracic tumours non-NSCLC (i.e. SCLC)
  • Stage other than IV or feasible for radical treatment upfront
  • Treatment within clinical trials (with combination regimens different from the aforementioned combinations)
  • Lost to follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mono-immunotherapy
Patients with NSCLC stage IV treated with immunotherapy alone as first-line treatment
Drug: Immunotherapy
First-line regimen according to clinical practice
Chemo-immunotherapy
Patients with NSCLC stage IV treated with chemo-immunotherapy as first-line treatment
Drug: Immunotherapy
First-line regimen according to clinical practice
Drug: Chemotherapy
First-line regimen according to clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early progressive disease
Time Frame: From date of enrolment until the date of first documented disease progression or death, whichever comes first, assessed within 8 to 12 weeks from first-line treatment start
Number of patients experiencing progressive disease (PD) as best response to first-line treatment
From date of enrolment until the date of first documented disease progression or death, whichever comes first, assessed within 8 to 12 weeks from first-line treatment start
Lung toxicity
Time Frame: From date of enrolment until the date of first documented immune-related pneumonitis of G3 or more, assessed up to 96 months
Number of patients experiencing immune-related pneumonitis of G3 or more
From date of enrolment until the date of first documented immune-related pneumonitis of G3 or more, assessed up to 96 months
Long survivors
Time Frame: At a 3-year cut-off
Numbero of patients experiencing an overall survival (time from treatment initiation to death) longer than 3 years (1.5x median overall survival from clinical trials)
At a 3-year cut-off

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 29, 2024

First Submitted That Met QC Criteria

January 20, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 20, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI-HOPE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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