Clinical trial · Interventional
Tumor Treating Fields (TTF) in Combination with Stereotactic Radiosurgery(SRS) for Brain Metastases from Non-small Cell Lung Cancer.
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.
NCT06716775CI-TRIAL-00083314not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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) .
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NSCLC Brain Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best Standard of Care | Other | — | UNRESOLVED |
| Tumor treating felds (TTF) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TTF+Best Standard of Care
- interventionNames
- Device: Tumor treating felds (TTF)
- Other: Best Standard of Care
- type
- ACTIVE_COMPARATOR
- label
- Best Standard of Care
- interventionNames
- Other: Best Standard of Care
Primary outcomes (1)
- measure
- Intracranial tumor progression-free survival (iPFS)
- timeFrame
- 3 years
- description
- Defined as the time from randomization to the first occurrence of intracranial progression (according to RANO-BM criteria) or neurologic death, whichever occurred first.
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.