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

San Donato Group (GSD)

Status

Enrolling

Conditions

NSCLC Stage IV

Treatments

Drug: Chemotherapy

Drug: Immunotherapy

Study type

Observational

Funder types

Other

Identifiers

NCT06788366

AI-HOPE

Details and patient eligibility

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).

Enrollment

2,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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