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Not yet recruiting NCT06716775

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

No phase Interventional NSCLC Brain Metastasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tumor treating felds (TTF), Best Standard of Care.
Who it may be relevant to
Registry conditions: NSCLC Brain Metastasis. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Tumor Treating Fields (TTF) in Combination with Stereotactic Radiosurgery(SRS) for Brain Metastases from Non-small Cell Lung Cancer: a Randomized, Controlled, Open-label Study.

Overview

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) .

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.

Primary outcome measures

  • Intracranial tumor progression-free survival (iPFS) [Time frame: 3 years]
Secondary outcome measures (7)
  • Overall Survival (OS) [Time frame: 3 years]
  • Objective response rate (ORR) [Time frame: 3 years]
  • Time to neurocognitive failure [Time frame: 3 years]
  • Rate of intracranial progression at 2, 4, 6, 8, 10, 12 months [Time frame: 3 years]
  • Neurocognitive failure-free survival [Time frame: 3 years]
  • Rate of decline in cognitive function [Time frame: 3 years]
  • Number of participants with adverse events (AEs) [Time frame: 3 years]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • Positive driver genes;
  • Recurrent brain metastasis of NSCLC;
  • Suffering from severe cerebral edema;
  • Leptomeningeal metastases;
  • 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:
  • platelet count < 100×103/μL;
  • 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);

  • There were infection, ulcer and unhealed wound in the skin where the electrode was applied；
  • Patients allergic to conductive hydrogels or medical adhesives;
  • Those who are pregnant or preparing to become pregnant or who are breastfeeding;
  • Patients with poor compliance, as judged by the investigator, or other factors considered by the investigator to be not suitable for the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06716775 · HL-10

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗