NSCLC Stage IVNCT06788366
AI-HOPE Lung Cancer: Building a Predictive Tool for Metastatic Lung Cancer
An observational study of NSCLC Stage IV, run by IRCCS San Raffaele at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC Stage IV
- What is being tested?
- Immunotherapy and Chemotherapy
- Type of treatment
- Injection or infusion
- How many people
- 2,000 participants
- Where
- 1 siteItaly
- Study dates
- 12 Feb 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with NSCLC stage IV treated with at least 1 cycle of first-line treatment
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Clinical Trial Center OSR contact
Italy1 site, 1 recruiting
- Recruiting
Francesca Rita Ogliari
Milan, 20132
Francesca Rita Ogliari, oncologia.medica@hsr.it
Francesca Rita Ogliari
About this study
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).
Read more
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
- Being tested
- Immunotherapy, Chemotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunotherapyDrug
First-line regimen according to clinical practice
ChemotherapyDrug
First-line regimen according to clinical practice
| Study group | Role | What they receive |
|---|---|---|
| Mono-immunotherapy | Patients with NSCLC stage IV treated with immunotherapy alone as first-line treatment Receives: Drug: Immunotherapy | |
| Chemo-immunotherapy | Patients with NSCLC stage IV treated with chemo-immunotherapy as first-line treatment Receives: Drug: Immunotherapy; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early progressive disease
Number of patients experiencing progressive disease (PD) as best response to first-line treatment
Measured: 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
Measured: 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)
Measured: At a 3-year cut-off
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start12 Feb 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC Stage IVStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesca Rita Ogliari, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06788366
- Sponsor's protocol ID
- AI-HOPE
- Status last verified
- Jan 2025
- First submitted
- 29 Feb 2024
- Last updated
- 23 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-HOPE Lung Cancer: Building a Predictive Tool for Metastatic Lung Cancer
- ClinicalTrials.gov ID
- NCT06788366
- Acronym / sponsor ID
- AI-HOPE
- Conditions
- NSCLC Stage IV
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mono-immunotherapy | – | Drug: ImmunotherapyPatients with NSCLC stage IV treated with immunotherapy alone as first-line treatment |
| Chemo-immunotherapy | – | Drug: Immunotherapy, Drug: ChemotherapyPatients with NSCLC stage IV treated with chemo-immunotherapy as first-line treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with NSCLC stage IV treated with at least 1 cycle of first-line treatment
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImmunotherapyFirst-line regimen according to clinical practice | Drug | Chemo-immunotherapy, Mono-immunotherapy |
| ChemotherapyFirst-line regimen according to clinical practice | Drug | Chemo-immunotherapy |
Primary outcome
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
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
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for NSCLC Stage IV
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Active, not recruitingPhase 2
A Study of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H/KEYMAKER-U01)
Carcinoma, Non-Small-Cell Lung
Active, not recruitingPhase 2
CAN-2409 Plus Prodrug With Standard of Care Immune Checkpoint Inhibitor for Stage III/IV NSCLC
Non Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Trial Center OSR contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC Stage IV, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesca Rita Ogliari, MD (0039 02 2643 2643, oncologia.medica@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.