Using AI to predict treatment outcomes in lung cancer patients with 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

This study is testing if using artificial intelligence to look at brain and lung scans can help predict how well treatment will work for people with advanced lung cancer that has spread to the brain.

Quick facts

• Study type: Observational
• Enrollment: 800 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06604689 on ClinicalTrials.gov

What this trial studies

This observational study aims to utilize deep learning to analyze imaging features of brain and lung lesions in patients with advanced non-small cell lung cancer (NSCLC) who have brain metastases. By collecting regular contrast-enhanced chest CT and brain MRI scans from participants receiving third-generation EGFR-TKI treatment, the study seeks to construct a multimodal model that predicts treatment efficacy and survival. The model will also help identify high-risk patients who may benefit from upfront cranial radiotherapy.

Who should consider this trial

Good fit: Ideal candidates include adults with pathologically confirmed stage IV NSCLC and specific EGFR mutations who have brain metastases.

Not a fit: Patients with multiple primary or metastatic tumors or those without EGFR sensitive mutations may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies and outcomes for lung cancer patients with brain metastases.

How similar studies have performed: Other studies utilizing AI for prognostication in cancer have shown promising results, indicating potential success for this approach.

Eligibility criteria

Inclusion Criteria:

* 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;
* 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.

Exclusion Criteria:

* 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.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Cancer center — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: zhengfei Zhu

Conditions NSCLC; Brain Metastasases