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

Recruiting

• Conditions: NSCLC (Advanced Non-small Cell Lung Cancer); Brain Metastasases
• Interventions: Drug: third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib)

• Registration Number: NCT06604689
• Lead Sponsor: Fudan University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-18
• Study First Submitted QC: 2024-09-18
• Study First Posted: 2024-09-19
• Study Start: 2024-09-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-08
• Last Update Posted: 2024-11-11
• Primary Completion: 2025-04-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Construction of AI models (retrospective cohort)	third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib)	-
Validation of AI models (prospective cohort)	third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib)	-

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	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.

Secondary Outcome Measures

Name	Time	Method
Intracranial Objective Response Rate (iORR)	1 year	The percentage of participants in the analysis population whose brain lesions achieve CR or PR, assessed according to the modified RECIST 1.1 criteria.
Intracranial Progression-Free Survival (iPFS)	1 year	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.
Overall Survival (OS)	1 year	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.
Objective Response Rate (ORR)	1 year	The percentage of participants who achieve a Complete Response (CR) or Partial Response (PR) after treatment, assessed according to the RECIST 1.1 criteria.

Trial Locations

Locations (1)

Shanghai Cancer center; 🇨🇳 Shanghai, Shanghai, China