Your session is about to expire
← Back to Search
Device
Radiosurgery + TTFields for Lung Cancer
Phase 3
Waitlist Available
Led By Minesh Mehta, MD
Research Sponsored by NovoCure GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
1 inoperable brain metastasis or 2- 10 brain lesions per screening MRI, confirmed by contrast enhanced MRI amenable to SRS according to specific criteria
18 years of age and older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial tests a device to treat brain metastases in advanced NSCLC patients, comparing it to the current standard of care.
Who is the study for?
This trial is for adults with a new diagnosis of 1 inoperable brain metastasis or 2-10 brain lesions from NSCLC, confirmed by MRI. Participants must have a life expectancy of at least 3 months, be able to use the NovoTTF-200M device independently or with help, and not be part of other trials involving brain therapy.Check my eligibility
What is being tested?
The study compares the effectiveness and safety of using the NovoTTF-200M device alongside standard supportive treatment versus supportive treatment alone for NSCLC patients after radiosurgery for brain metastases.See study design
What are the potential side effects?
Potential side effects may include skin irritation beneath electrode arrays, headaches, malaise due to carrying the device, and possible interference with underlying conditions due to electric fields.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have 1 to 10 brain tumors that cannot be removed by surgery but can be treated with targeted radiation.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to intracranial progression
Secondary outcome measures
Neurocognitive failure-free survival
Overall survival
Quality of Life using the EORTC QLQ C30 with BN20 addendum
+9 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: NovoTTF-200M deviceExperimental Treatment2 Interventions
NovoTTF-200M device Patients undergo SRS followed by continuous TTFields treatment using the NovoTTF-200M device. TTFields treatment will consist of wearing four electrically insulated electrode arrays on the head.
The treatment enables the patient to maintain regular daily routine.
Group II: Best Standard of CareActive Control1 Intervention
Patients will undergo SRS alone and be treated with the best known standard of care for Non-Small Cell Lung Cancer metastatic to the brain.
Find a Location
Who is running the clinical trial?
NovoCure GmbHLead Sponsor
11 Previous Clinical Trials
2,469 Total Patients Enrolled
Minesh Mehta, MDPrincipal InvestigatorMiami Cancer Institute, Miami FL USA
1 Previous Clinical Trials
624 Total Patients Enrolled
Paul Brown, MDPrincipal InvestigatorMD Anderson Cancer Center, Houston TX USA
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has specific gene mutations treatable with targeted drugs for brain metastasis.8. You can use the NovoTTF-200M device by yourself or with the help of a caregiver.
9. You can have taken part in other clinical trials before, as long as they did not involve treatment specifically targeting the brain.I have seizures that cannot be controlled with medication.My cancer has spread to the lining of my brain and spinal cord.I do not have severe health issues that could affect my participation in the study.I have one treatable brain tumor.I have 1 to 10 brain tumors that cannot be removed by surgery but can be treated with targeted radiation.I am on the best treatment for my cancer outside the brain and can continue it while starting TTFields.I have not had any treatments aimed at the brain in previous clinical trials.My lung cancer has spread to my brain within the last 5 years.I have had whole brain radiation therapy for brain metastases.You have a large shift in the middle of your brain.You are expected to live for at least 3 more months.You have at least one specific disease that can be measured according to the study's guidelines.My cancer has spread to my brain more than once.1. Your largest tumor is smaller than 10 cc.
2. Your longest tumor is smaller than 3 cm.
3. The total size of all your tumors combined is less than or equal to 15 cc.
4. You have at least one tumor that can be measured according to the study rules.
5. You are getting the best treatment for your condition based on local guidelines.I have severe swelling in my brain that could lead to dangerous pressure.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: NovoTTF-200M device
- Group 2: Best Standard of Care
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger