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.

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) .

Study Overview

• Status: Not yet recruiting
• Conditions: NSCLC Brain Metastasis
• Intervention / Treatment: Device: Tumor treating felds (TTF); Other: Best Standard of Care

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ligang Xing Dr Xing, Doctor; Phone Number: (0531)87984777; Email: xinglg@medmail.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TTF+Best Standard of Care	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.
Active Comparator: Best Standard of Care	Other: Best Standard of Care; Patients will be treated with the best known standard of care for NSCLC brain metastasis and undergo SRS alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Defined as the time from the date of treatment until death due to any cause.	3 years
Objective response rate (ORR)	Defined as the number (%) of patients with at least 1 visit response of complete response (CR) or partial response (PR).	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
Rate of decline in cognitive function		3 years
Number of participants with adverse events (AEs)	Adverse events will be defined as the incidence, frequency and severity of adverse events (AEs) noted in patients treated with study treatments	3 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): December 20, 2024
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): October 30, 2028

Study Registration Dates

• First Submitted: November 29, 2024
• First Submitted That Met QC Criteria: December 2, 2024
• First Posted (Estimated): December 4, 2024

Study Record Updates

• Last Update Posted (Estimated): December 4, 2024
• Last Update Submitted That Met QC Criteria: December 2, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: TTF; NSCLC brain metastasis
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Neoplasms by Site; Neoplasms; Neoplastic Processes; Nervous System Neoplasms; Central Nervous System Neoplasms; Neoplasm Metastasis; Brain Neoplasms
• Other Study ID Numbers: HL-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No