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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mono-immunotherapy | Patients with NSCLC stage IV treated with immunotherapy alone as first-line treatment |
| |
| Chemo-immunotherapy | Patients with NSCLC stage IV treated with chemo-immunotherapy as first-line treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunotherapy | Drug | First-line regimen according to clinical practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria:
Exclusion criteria:
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Patients with NSCLC stage IV treated with at least 1 cycle of first-line treatment
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesca Rita Ogliari, MD | Contact | 0039 02 2643 2643 | oncologia.medica@hsr.it | |
| Clinical Trial Center OSR | Contact | ctc.trialmanagement@hsr.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Francesca Rita Ogliari | Recruiting | Milan | 20132 | Italy |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 6, 2024 | Jan 15, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D007167 | Immunotherapy |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| Chemotherapy | Drug | First-line regimen according to clinical practice |
|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |