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NCT Number: NCT06552000

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.

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Key information

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location contact

Ebele Mbanugo, Ed.D, CCRP

CONTACT

[email protected]

214-645-0326

John Waters, MD

PRINCIPAL_INVESTIGATOR

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

NovoTTF-200T System

Device

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)

Primary outcomes

  1. Effect of TTF (Tumor-Treating Fields) on Fanconi anemia-related genes.

    Time frame: approximately 14-28 days

    Determine the effect of TTFields on expression of Fanconi anemia pathway-associated genes in NSCLC.

Secondary outcomes

  1. Safety of administering TTFields

    Time frame: approximately 14-28 days

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ebele Mbanugo, Ed.D, CCRP

CONTACT

[email protected]

214-645-0326

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • NovoCure Ltd.

Registry information

Official study title

Phase 0 Trial of Pre-operative Tumor Treating Fields in Patients With Resectable Lung Cancer

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Aug 13, 2024
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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