RecruitingNCT06788366

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


Sponsor

IRCCS San Raffaele

Enrollment

2,000 participants

Start Date

Feb 12, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is using artificial intelligence to analyze data from patients with advanced non-small cell lung cancer (a common type of lung cancer) in order to build a tool that predicts how the cancer will spread (metastasize). This is an observational study — it collects information from patients already receiving treatment, without changing their care. **You may be eligible if...** - You have been diagnosed with non-small cell lung cancer (NSCLC) confirmed by a tissue or cell test - Your cancer is at stage IV (spread to other parts of the body) or is too advanced for localized treatment - You have already received at least one cycle of immunotherapy (with or without chemotherapy) as part of your standard care - You have follow-up care available at the study site **You may NOT be eligible if...** - You have a different type of thoracic (chest) cancer, such as small cell lung cancer (SCLC) - Your cancer is not stage IV or is still potentially curable with local treatment - You received your treatment as part of a different clinical trial using combination drugs not included in this study - You have been lost to follow-up (no longer being tracked by doctors) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGImmunotherapy

First-line regimen according to clinical practice

DRUGChemotherapy

First-line regimen according to clinical practice


Locations(1)

Francesca Rita Ogliari

Milan, Italy

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NCT06788366


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