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

NCT06788366 | Recruiting

• 1 other identifier: AI-HOPE
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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).

Conditions

NSCLC Stage IV

Outcome Measures

Primary Outcomes (3)

• Early progressive disease

  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

  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

  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

Study Arms (2)

Mono-immunotherapy

Patients with NSCLC stage IV treated with immunotherapy alone as first-line treatment

Drug: Immunotherapy

Chemo-immunotherapy

Patients with NSCLC stage IV treated with chemo-immunotherapy as first-line treatment

Drug: Immunotherapy; Drug: Chemotherapy

Interventions

Immunotherapy DRUG

First-line regimen according to clinical practice

Chemo-immunotherapy; Mono-immunotherapy

Chemotherapy DRUG

First-line regimen according to clinical practice

Chemo-immunotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

Francesca Rita Ogliari

Milan, 20132, Italy

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Immunotherapy; Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Central Study Contacts

Francesca Rita Ogliari, MD

CONTACT

0039 02 2643 2643; oncologia.medica@hsr.it

Clinical Trial Center OSR

CONTACT

ctc.trialmanagement@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Medical doctor

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: January 23, 2025
• Study Start: February 12, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)