Tumor Treating Fields (TTF) in Combination with Stereotactic Radiosurgery(SRS) for Brain Metastases from Non-small Cell Lung Cancer.

Study Purpose

This is a randomized, controlled, open-label, phase III trials. The main purpose of this study is to evaluate the effectiveness and safety of tumor treating felds (TTF) combined with stereotactic radiosurgery (SRS) in the treatment of brain metastases from non-small cell lung cancer (NSCLC) .

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. The age of the subject was between 18 and 75 years old (inclusive), regardless of gender; 2. The predicted survival time was ≥3 months; 3. Newly diagnosed with NSCLC brain metastasis; 4. MRI imaging showed 1-10 unresectable brain metastases; 5. Karnofsky performance status (KPS) score ≥70; 6. Able to operate the TTF independently or with the help of a caregiver; 7. Subjects of childbearing potential had to agree to use effective contraception for the duration of the trial; 8. Voluntarily signed the informed consent form.

Exclusion Criteria:

1. Positive driver genes; 2. Recurrent brain metastasis of NSCLC; 3. Suffering from severe cerebral edema; 4. Leptomeningeal metastases; 5. Participants had to meet certain criteria for bone marrow, liver and kidney function before enrollment, and were not eligible if they had any of the following: 1. platelet count < 100×103/μL; 2. absolute neutrophil count < 1.5×103/μL; d. AST or ALT exceeding 2.5 times the upper limit of normal; c.Total bilirubin more than 1.5 times the upper limit of the normal range; d.Severe renal impairment (serum creatinine >1.7 mg/dL, or >150 μmol/L); 6. There were infection, ulcer and unhealed wound in the skin where the electrode was applied； 7. Patients allergic to conductive hydrogels or medical adhesives; 8. Those who are pregnant or preparing to become pregnant or who are breastfeeding; 9. Patients with poor compliance, as judged by the investigator, or other factors considered by the investigator to be not suitable for the study.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06716775
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Jiangsu Healthy Life Innovation Medical Technology Co., Ltd
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry, Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	NSCLC Brain Metastasis

Arms & Interventions

Arms

Experimental: TTF+Best Standard of Care

Active Comparator: Best Standard of Care

Interventions

Device: - Tumor treating felds (TTF)

Tumor Treating Fields will be administered continuously with a planned ≥ 18 h per day.

Other: - Best Standard of Care

Patients will be treated with the best known standard of care for NSCLC brain metastasis and undergo SRS alone.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Ligang Xing Dr Xing, Doctor

[email protected]

(0531)87984777

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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