Actively Recruiting

Age: 18Years +
All Genders
NCT06788366

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

Led by IRCCS San Raffaele · Updated on 2025-01-23

2000

Participants Needed

1

Research Sites

150 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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

You will not qualify if you...

  • Patients with other thoracic tumours non-NSCLC such as small cell lung cancer (SCLC)
  • Stage other than IV or feasible for radical treatment upfront
  • Treatment within clinical trials using combination regimens different from those specified
  • Lost to follow-up

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Francesca Rita Ogliari

Milan, Italy, 20132

Actively Recruiting

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Research Team

F

Francesca Rita Ogliari, MD

CONTACT

C

Clinical Trial Center OSR

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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