NSCLCNCT06552000
Pre-operative Tumor Treating Fields in Patients With Resectable Lung Cancer
A study testing NovoTTF-200T System in people with NSCLC and Non Small Cell Lung Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to study the clinical and biologic effects of Tumor Treatment Fields (TTFields) in patients undergoing resection of stage I-IIIA Non-Small Cell Lung Cancer (NSCLC). TTField is a non-invasive treatment that uses low-intensity electrical fields to treat cancer. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- NSCLC, Non Small Cell Lung Cancer
- What is being tested?
- NovoTTF-200T System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 1 Dec 2030
- Phase
- Interventional
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of stage I-IIIA NSCLC planned for surgical resection.
- Eastern Cooperative Oncology Group (ECOG) 0-2 performance status.
- Willingness and ability to undergo planned correlative studies, including imaging tests.
- Fresh biopsy diagnostic material obtained from standard of care procedure to perform baseline correlatives (10-15 slides)-if not available, enrollment will be considered on a case-by-case basis after discussion with and approval by the Lead Site PI or Lead Site Co-Principal Investigator.
- Ability to understand and the willingness to sign a written informed consent.
- All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
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- 6a. A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- • Has not undergone a hysterectomy or bilateral oophorectomy; or
- • Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- Age ≥22 years at time of screening.
Who cannot join
- Receipt of prior therapy for the current NSCLC.
- Planned neoadjuvant therapy for the current NSCLC.
- History of major allergic reactions attributed to adhesive or compounds in TTFields micro-array.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.
- Pregnant or nursing patients due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
- Use of electronic devices or prosthetics - i.e., pacemakers, defibrillators, spinal infusion pumps. Specific scenarios can be discussed with the Lead Site PI or Lead Site Co-Principal Investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
Official title: Phase 0 Trial of Pre-operative Tumor Treating Fields in Patients With Resectable Lung Cancer
The purpose of this study is to study the clinical and biologic effects of Tumor Treatment Fields (TTFields) in patients undergoing resection of stage I-IIIA Non-Small Cell Lung Cancer (NSCLC). TTField is a non-invasive treatment that uses low-intensity electrical fields to treat cancer. Resection is the medical term for surgically removing part or all of a tissue, structure, or organ.
Read the detailed description
To study the clinical and biologic effects of Tumor Treatment Fields (TTFields) in patients undergoing resection of stage I-IIIA NSCLC.
Participants in this study will have a blood sample collected as well as vital signs along with a tumor tissue sample and tumor scan. Once it has been determined the participant can enroll into this study, he/she will come to the clinic for 5 scheduled visits over a period of 2 months .
- Conditions
- NSCLC, Non Small Cell Lung Cancer
- Being tested
- NovoTTF-200T System
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NovoTTF-200T SystemDevice
Exposure/Frequency: 150 kHz Route: Transdermal through patented microarray system to the hemithorax affected with cancer, 2-4 week duration, target 18 hours/day (on average)
| Study group | Role | What they receive |
|---|---|---|
| Tumor Treatment Fields | Experimental | Duration: 2-4 week; target 18 hours/day (on average). Continuous between time of enrollment and date of surgery.
Cycle Length: 2-4 weeks Receives: Device: NovoTTF-200T System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of TTF (Tumor-Treating Fields) on Fanconi anemia-related genes.
Determine the effect of TTFields on expression of Fanconi anemia pathway-associated genes in NSCLC.
Measured: approximately 14-28 days
Secondary outcomes (1)
Safety of administering TTFields
Assess the safety of administering TTFields prior to standard of care lung cancer resection.
Analyses will be performed for all subjects having initiated TTFields therapy. The study will use the CTCAE version 5.0 for reporting of adverse events.
Measured: approximately 14-28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start1 Oct 2026 (estimated)
- Primary completion1 Dec 2029 (estimated)
- Study completion1 Dec 2030 (estimated)
Why it stopped: Sponsor deprioritized the study and made the choice to close the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- NovoCure Ltd.
- Responsible party
- Principal investigator, John Waters, University of Texas Southwestern Medical Center
- Investigators
- John Waters, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06552000
- Sponsor's protocol ID
- SCCC 07524; STU-2024-0624
- Status last verified
- Sep 2026
- First submitted
- 9 Aug 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No