NSCLC Brain MetastasisNCT06716775
Tumor Treating Fields (TTF) in Combination with Stereotactic Radiosurgery(SRS) for Brain Metastases from Non-small Cell Lung Cancer.
A study testing Tumor treating felds (TTF) in people with NSCLC Brain Metastasis, run by Jiangsu Healthy Life Innovation Medical Technology Co., Ltd.
Trial 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) . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC Brain Metastasis
- What is being tested?
- Tumor treating felds (TTF)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2024to 30 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- absolute neutrophil count < 1.5×103/μL;
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
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
- Being tested
- Tumor treating felds (TTF), Best Standard of Care
- Keywords
- TTF, NSCLC brain metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor treating felds (TTF)Device
Tumor Treating Fields will be administered continuously with a planned ≥ 18 h per day.
Best Standard of CareOther
Patients will be treated with the best known standard of care for NSCLC brain metastasis and undergo SRS alone.
| Study group | Role | What they receive |
|---|---|---|
| TTF+Best Standard of Care | Experimental | Not described Receives: Device: Tumor treating felds (TTF); Other: Best Standard of Care |
| Best Standard of Care | Active comparator | Not described Receives: Other: Best Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (7)
Overall Survival (OS)
Defined as the time from the date of treatment until death due to any cause.
Measured: 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).
Measured: 3 years
Time to neurocognitive failure
Measured: 3 years
Rate of intracranial progression at 2, 4, 6, 8, 10, 12 months
Measured: 3 years
Neurocognitive failure-free survival
Measured: 3 years
Rate of decline in cognitive function
Measured: 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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start20 Dec 2024 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC Brain MetastasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Healthy Life Innovation Medical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shandong Cancer Hospital and Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06716775
- Sponsor's protocol ID
- HL-10
- Status last verified
- Dec 2024
- First submitted
- 29 Nov 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06716775
- Acronym / sponsor ID
- HL-10
- Conditions
- NSCLC Brain Metastasis
- Keywords
- TTF, NSCLC brain metastasis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jiangsu Healthy Life Innovation Medical Technology Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Shandong Cancer Hospital and Institute
- Study start
- 20 Dec 2024 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (12 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tumor treating felds (TTF)Tumor Treating Fields will be administered continuously with a planned ≥ 18 h per day. | Device | TTF+Best Standard of Care |
| Best Standard of CarePatients will be treated with the best known standard of care for NSCLC brain metastasis and undergo SRS alone. | Other | Best Standard of Care, TTF+Best Standard of Care |
Primary outcome
Intracranial tumor progression-free survival (iPFS)
Time frame: 3 years
Defined as the time from randomization to the first occurrence of intracranial progression (according to RANO-BM criteria) or neurologic death, whichever occurred first.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Tumor treating felds (TTF) in people with NSCLC Brain Metastasis, run by Jiangsu Healthy Life Innovation Medical Technology Co., Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ligang Xing Dr Xing, Doctor ((0531)87984777, xinglg@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracranial tumor progression-free survival (iPFS) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.