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Recruiting

NCT Number: NCT06788366

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

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).

Recruiting

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Key information

Conditions

NSCLC Stage IV Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Francesca Rita Ogliari

Milan, 20132, Italy

Location status: Recruiting

Location contact

Francesca Rita Ogliari

CONTACT

[email protected]

Francesca Rita Ogliari

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Immunotherapy

Drug

First-line regimen according to clinical practice

Chemotherapy

Drug

First-line regimen according to clinical practice

Primary outcomes

  1. Early progressive disease

    Time frame: 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

  2. Lung toxicity

    Time frame: 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

  3. Long survivors

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trial Center OSR

CONTACT

[email protected]

Francesca Rita Ogliari, MD

CONTACT

[email protected]

0039 02 2643 2643

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2025
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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