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) .
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;
Positive driver genes;
Recurrent brain metastasis of NSCLC;
Suffering from severe cerebral edema;
Leptomeningeal metastases;
Parallel
Tumor treating felds (TTF)
DeviceTumor Treating Fields will be administered continuously with a planned ≥ 18 h per day.
Best Standard of Care
Other interventionPatients will be treated with the best known standard of care for NSCLC brain metastasis and undergo SRS alone.
Intracranial tumor progression-free survival (iPFS)
Defined as the time from randomization to the first occurrence of intracranial progression (according to RANO-BM criteria) or neurologic death, whichever occurred first.
Overall Survival (OS)
Defined as the time from the date of treatment until death due to any cause.
Objective response rate (ORR)
Defined as the number (%) of patients with at least 1 visit response of complete response (CR) or partial response (PR).
Time to neurocognitive failure
Rate of intracranial progression at 2, 4, 6, 8, 10, 12 months
Click on the lead sponsor to view all of their trials.
Jiangsu Healthy Life Innovation Medical Technology Co., Ltd
Lead sponsor
Shandong Cancer Hospital and Institute
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
