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

NCT06716775 | Not Yet Recruiting DMC

• 1 other identifier: HL-10
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

NSCLC Brain Metastasis

Keywords

TTF; NSCLC brain metastasis

Outcome Measures

Primary Outcomes (1)

• 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.

  3 years

Secondary Outcomes (7)

• Overall Survival (OS)

  3 years

• Objective response rate (ORR)

  3 years

• Time to neurocognitive failure

  3 years

• Rate of intracranial progression at 2, 4, 6, 8, 10, 12 months

  3 years

• Neurocognitive failure-free survival

  3 years

Study Arms (2)

TTF+Best Standard of Care

EXPERIMENTAL

Device: Tumor treating felds (TTF); Other: Best Standard of Care

Best Standard of Care

ACTIVE COMPARATOR

Other: Best Standard of Care

Interventions

Tumor treating felds (TTF) DEVICE

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

TTF+Best Standard of Care

Best Standard of Care OTHER

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

Best Standard of Care; TTF+Best Standard of Care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu Healthy Life Innovation Medical Technology Co., Ltd: lead
• Shandong Cancer Hospital and Institute: collaborator

Central Study Contacts

Ligang Xing Dr Xing, Doctor

CONTACT

(0531)87984777; xinglg@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 4, 2024
• Study Start: December 20, 2024
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): October 30, 2028
• Last Updated: December 4, 2024

Record last verified: 2024-12