Risk and Prognosis of Brain Metastasis in Non-Small Cell Lung Cancer

Not yet recruiting

• Conditions: NSCLC (Non-small Cell Lung Cancer); Brain Metastases From Non-small Cell Lung Cancer (NSCLC)

• Registration Number: NCT07034365
• Lead Sponsor: Fudan University

Brief Summary

This multi-center, prospective, observational study aim to construct a comprehensive model, integrating common clinical pathological parameters, radiographic features and multi-omics data, for assessing the risk and prognosis of brain metastasis in NSCLC. This model is intended to address the following clinical needs: (1) Identify patients at high risk of brain metastasis; (2) Optimize the combined strategies of local and systemic treatments; (3) Predict the survival outcomes of patients with brain metastases from NSCLC and provide evidence-based support for individualized treatment decisions.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-15
• Study First Submitted QC: 2025-06-15
• Study First Posted: 2025-06-24
• Last Update Submitted: 2025-06-25
• Last Update Posted: 2025-06-29
• Study Start: 2025-08-01
• Primary Completion: 2026-12
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• Pathologically confirmed non-small cell lung cancer;
• Age≥18 years old;
• KPS score≥70;
• Complete systemic imaging (including brain MRI) before treatment initiation, including contrast-enhanced MRI of the brain;
• Receiving standard 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);
• Physical examination findings, clinical laboratory abnormalities, or other uncontrolled medical conditions identified by the investigator as potentially interfering with study results interpretation or increasing the patient's risk of - 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;
• Pregnant or lactating women.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	2 years	The time from enrollment to disease progression or death from any cause. Patients who were still alive at the time of analysis will have the date of their last contact as the cutoff date.

Secondary Outcome Measures

Name	Time	Method
Intracranial Progression-Free Survival (iPFS)	2 years	The time from the enrollment 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)	2 years	The time from the start of systemic 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.