NSCLC (Advanced Non-small Cell Lung Cancer)NCT06604689
AI-guided Prognostication and Cranial Radiotherapy Optimization in EGFR-TKI-treated Non-small Cell Lung Cancer Patients With Baseline Brain Metastases
An observational study of NSCLC (Advanced Non-small Cell Lung Cancer) and Brain Metastasases, run by Fudan University at 1 site in China.
Trial summary
The goal of this observational study is to extract the imaging features of brain lesions and primary lung lesions in NSCLC patients with brain metastases by deep learning, as well as common clinicopathological parameters, which are used to construct a multimode model that can accurately predict the treatment efficacy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC (Advanced Non-small Cell Lung Cancer), Brain Metastasases
- What is being tested?
- third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib)
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2024to 1 Oct 2025
- 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 are collected all over china, diagnosed with EGFR-mutant NSCLC with brain metastases.
Who may be able to join
- Pathologically confirmed non-small cell lung cancer;
- clinical stage IV (AJCC, 8th edition, 2017);
- EGFR sensitive mutations: EGFR L858R, EGFR exon 19 deletion;
- age≥18 years old;
- KPS score≥70;
- brain metastases at diagnosis;
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- complete systemic imaging (including brain MRI) before third-generation EGFR-TKI treatment;
- received standard third-generation EGFR-TKI therapy (monotherapy or combined with brain radiotherapy);
- willing to cooperate with the follow-up after third-generation EGFR-TKI treatment;
- informed consent of the patient.
Who cannot join
- Multiple primary or metastatic tumors (except early skin cancer, cervical carcinoma in situ that has been treated radically, with no recurrence or progression for more than 5 years);
- Pregnant or lactating women who, as judged by the investigator, were not candidates for brain MRI;
- EGFR sensitive mutations were negative or EGFR mutation status was not detected.
- Uncontrolled epilepsy, central nervous system disease, or history of mental disorders, judged by the researcher to potentially interfere with the signing of the informed consent form or affect patient compliance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Cancer center
Shanghai, Shanghai Municipality, 200050
Zhengfei Zhu, PhD, 86+137 6408 8764, fuscczzf@163.com
About this study
Official title: Artificial Intelligence-guided Prognostication and Cranial Radiotherapy Optimization in First-line Third-generation EGFR-TKI-treated EGFR-mutant Non-small Cell Lung Cancer With Baseline Brain Metastases: a Multicenter, Observational Study
The goal of this observational study is to extract the imaging features of brain lesions and primary lung lesions in NSCLC patients with brain metastases by deep learning, as well as common clinicopathological parameters, which are used to construct a multimode model that can accurately predict the treatment efficacy and survival of the third-generation EGFR-TKI treatment, and to use the model to assist in screening high-risk populations suitable for upfront cranial radiotherapy.
Participants receiving third-generation EGFR-TKI treatment will be enrolled in our study and we will collect their regular contrast-enhanced chest CT and contrast-enhanced brain MRI for model construction.
- Being tested
- third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib)
- 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.
third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib)Drug
EGFR-mutated NSCLC patients with brain metastases who met the inclusion and exclusion criteria, would receive first-line third-generation EGFR-TKI treatment (monotherapy or combined with upfront cranial radiotherapy)
| Study group | Role | What they receive |
|---|---|---|
| Construction of AI models (retrospective cohort) | Not described Receives: Drug: third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib) | |
| Validation of AI models (prospective cohort) | Not described Receives: Drug: third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
The time from the start of EGFR-TKI treatment until the documentation of disease progression or death from any cause, assessed according to the RECIST 1.1 criteria. Patients who are still alive at the time of analysis will have their last contact date used as the cutoff date.
Measured: 1 year
Secondary outcomes (4)
Intracranial Objective Response Rate (iORR)
The percentage of participants in the analysis population whose brain lesions achieve CR or PR, assessed according to the modified RECIST 1.1 criteria.
Measured: 1 year
Intracranial Progression-Free Survival (iPFS)
The time from the start of EGFR-TKI treatment until the documentation of intracranial disease progression or death from any cause. If the patients have extracranial disease progression (without intracranial disease progression), the cutoff date was the date of the first occurrence of extracranial disease progression. Patients who have not progressed at the time of analysis will have their last contact date used as the cutoff date.
Measured: 1 year
Overall Survival (OS)
The time from the start of EGFR-TKI treatment until death from any cause. Patients who are still alive at the time of analysis will have their last contact date used as the cutoff date.
Measured: 1 year
Objective Response Rate (ORR)
The percentage of participants who achieve a Complete Response (CR) or Partial Response (PR) after treatment, assessed according to the RECIST 1.1 criteria.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start30 Sep 2024
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC (Advanced Non-small Cell Lung Cancer)Studies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhengfei Zhu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06604689
- Sponsor's protocol ID
- BM-AI
- Status last verified
- Nov 2024
- First submitted
- 18 Sep 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence-guided Prognostication and Cranial Radiotherapy Optimization in First-line Third-generation EGFR-TKI-treated EGFR-mutant Non-small Cell Lung Cancer With Baseline Brain Metastases: a Multicenter, Observational Study
- ClinicalTrials.gov ID
- NCT06604689
- Acronym / sponsor ID
- BM-AI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 19 Sep 2024 (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 this observational study is to extract the imaging features of brain lesions and primary lung lesions in NSCLC patients with brain metastases by deep learning, as well as common clinicopathological parameters, which are used to construct a multimode model that can accurately predict the treatment efficacy and survival of the third-generation EGFR-TKI treatment, and to use the model to assist in screening high-risk populations suitable for upfront cranial radiotherapy.
Participants receiving third-generation EGFR-TKI treatment will be enrolled in our study and we will collect their regular contrast-enhanced chest CT and contrast-enhanced brain MRI for model construction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Construction of AI models (retrospective cohort) | – | Drug: third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib) |
| Validation of AI models (prospective cohort) | – | Drug: third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are collected all over china, diagnosed with EGFR-mutant NSCLC with brain metastases.
Key inclusion criteria (10 listed)
- Pathologically confirmed non-small cell lung cancer;
- clinical stage IV (AJCC, 8th edition, 2017);
- EGFR sensitive mutations: EGFR L858R, EGFR exon 19 deletion;
- age≥18 years old;
- KPS score≥70;
Key exclusion criteria (4 listed)
- Multiple primary or metastatic tumors (except early skin cancer, cervical carcinoma in situ that has been treated radically, with no recurrence or progression for more than 5 years);
- Pregnant or lactating women who, as judged by the investigator, were not candidates for brain MRI;
- EGFR sensitive mutations were negative or EGFR mutation status was not detected.
- Uncontrolled epilepsy, central nervous system disease, or history of mental disorders, judged by the researcher to potentially interfere with the signing of the informed consent form or affect patient compliance.
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 |
|---|---|---|
| third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib)EGFR-mutated NSCLC patients with brain metastases who met the inclusion and exclusion criteria, would receive first-line third-generation EGFR-TKI treatment (monotherapy or combined with upfront cranial radiotherapy) | Drug | Construction of AI models (retrospective cohort), Validation of AI models (prospective cohort) |
Primary outcome
Progression-Free Survival (PFS)
Time frame: 1 year
The time from the start of EGFR-TKI treatment until the documentation of disease progression or death from any cause, assessed according to the RECIST 1.1 criteria. Patients who are still alive at the time of analysis will have their last contact date used as the cutoff date.
4 secondary outcomes
Intracranial Objective Response Rate (iORR)
Time frame: 1 year
Intracranial Progression-Free Survival (iPFS)
Time frame: 1 year
Overall Survival (OS)
Time frame: 1 year
Objective Response Rate (ORR)
Time frame: 1 year
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 12 Nov 2024.
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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.
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 (Advanced Non-small Cell Lung Cancer) and Brain Metastasases, run by Fudan University at 1 site in China.
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 10 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 12 Nov 2024. 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 China. 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 zhengfei Zhu (+86-18017312901, fuscczzf@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: 1 year). 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 12 Nov 2024.