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

NCT06788366 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2025-01-23

No results posted yet for this study

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).

Conditions

  • NSCLC Stage IV

Interventions

DRUG

Immunotherapy

First-line regimen according to clinical practice

DRUG

Chemotherapy

First-line regimen according to clinical practice

Sponsors & Collaborators

  • IRCCS San Raffaele

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-12
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06788366 on ClinicalTrials.gov