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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07034365
Enrollment
2000
Registered
2025-06-24
Start date
2025-08-31
Completion date
2027-05-31
Last updated
2025-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Metastases From Non-small Cell Lung Cancer (NSCLC), NSCLC (Non-small Cell Lung Cancer)

Keywords

NSCLC, brain metastases, prognosis

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.

Interventions

OTHERNo intervention

No intervention

Sponsors

Fudan University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Progression-Free Survival (PFS)2 yearsThe 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

MeasureTime frameDescription
Intracranial Progression-Free Survival (iPFS)2 yearsThe 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 yearsThe 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.

Contacts

Primary ContactZhengfei Zhu, PhD
fuscczzf@163.com+8618017312901

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026