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

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.

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Key information

Conditions

NSCLC (Non-small Cell Lung Cancer) Brain Diseases Brain Metastases From Non-small Cell Lung Cancer (NSCLC) Brain Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Central Nervous System Diseases Central Nervous System Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

Progression-Free Survival (PFS)

Time frame: 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 outcomes

Intracranial Progression-Free Survival (iPFS)

Time frame: 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)

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhengfei Zhu, PhD

CONTACT

[email protected]

+8618017312901

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

Risk and Prognosis of Brain Metastasis in Non-Small Cell Lung Cancer: A Multicenter, Prospective, Observational Study

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2027
First posted: Jun 24, 2025
Registry last updated: Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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