Pre-operative Tumor Treating Fields in Patients With Resectable Lung Cancer

NCT06552000 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: SCCC 07524; STU-2024-0624
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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. Resection is the medical term for surgically removing part or all of a tissue, structure, or organ.

Conditions

NSCLC; Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  approximately 14-28 days

Secondary Outcomes (1)

• Safety of administering TTFields

  approximately 14-28 days

Study Arms (1)

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

Device: NovoTTF-200T System

Interventions

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)

Tumor Treatment Fields

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• a. 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• NovoCure Ltd.: collaborator

Study Sites (1)

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• John Waters, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ebele Mbanugo, Ed.D, CCRP

CONTACT

214-645-0326; ebele.mbanugo@utsouthwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Cardiovascular & Thoracic Surgery

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 13, 2024
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)