RecruitingNCT06604689

AI-guided Prognostication and Cranial Radiotherapy Optimization in EGFR-TKI-treated Non-small Cell Lung Cancer Patients With Baseline Brain Metastases

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


Sponsor

Fudan University

Enrollment

800 participants

Start Date

Sep 30, 2024

Study Type

OBSERVATIONAL

Conditions

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 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses artificial intelligence to help predict outcomes and guide radiation treatment decisions for people with advanced non-small cell lung cancer (NSCLC) that has spread to the brain. Participants have a specific genetic mutation (EGFR) and are being treated with targeted therapy pills called EGFR-TKIs. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with stage IV non-small cell lung cancer - Your tumor has an EGFR L858R or exon 19 deletion mutation - You had brain metastases (cancer spread to the brain) at the time of diagnosis - You are currently receiving or have received third-generation EGFR-TKI treatment - You had a complete imaging workup including a brain MRI before starting treatment - You have a good performance level (able to care for yourself) **You may NOT be eligible if...** - You have multiple different primary cancers (unless a skin cancer or cervical cancer that was fully treated more than 5 years ago) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGthird-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)


Locations(1)

Shanghai Cancer center

Shanghai, Shanghai Municipality, China

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NCT06604689


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