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

Recruiting

• Conditions: NSCLC Stage IV
• Interventions: Drug: Immunotherapy; Drug: Chemotherapy

• Registration Number: NCT06788366
• Lead Sponsor: IRCCS San Raffaele

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-12
• Study First Submitted: 2024-02-29
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-20
• Last Update Submitted: 2025-01-20
• Study First Posted: 2025-01-23
• Last Update Posted: 2025-01-23
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mono-immunotherapy	Immunotherapy	Patients with NSCLC stage IV treated with immunotherapy alone as first-line treatment
Chemo-immunotherapy	Immunotherapy	Patients with NSCLC stage IV treated with chemo-immunotherapy as first-line treatment
Chemo-immunotherapy	Chemotherapy	Patients with NSCLC stage IV treated with chemo-immunotherapy as first-line treatment

Primary Outcome Measures

Name	Time	Method
Early progressive disease	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
Lung toxicity	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
Long survivors	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)

Trial Locations

Locations (1)

Francesca Rita Ogliari; 🇮🇹 Milan, Italy