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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: NSCLC; Non Small Cell Lung Cancer
• Intervention / Treatment: Device: NovoTTF-200T System

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 .

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ebele Mbanugo, Ed.D, CCRP; Phone Number: 214-645-0326; Email: ebele.mbanugo@utsouthwestern.edu

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • The University of Texas Southwestern Medical Center
      • Contact: Ebele Mbanugo, Ed.D, CCRP; Phone Number: 214-645-0326; Email: ebele.mbanugo@utsouthwestern.edu
      • Principal Investigator: John Waters, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Diagnosis of stage I-IIIA NSCLC planned for surgical resection.
2. Eastern Cooperative Oncology Group (ECOG) 0-2 performance status.
3. Willingness and ability to undergo planned correlative studies, including imaging tests.
4. 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.
5. Ability to understand and the willingness to sign a written informed consent.

6. 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).
7. Age ≥22 years at time of screening.

Exclusion Criteria:

1. Receipt of prior therapy for the current NSCLC.
2. Planned neoadjuvant therapy for the current NSCLC.
3. History of major allergic reactions attributed to adhesive or compounds in TTFields micro-array.
4. 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.
5. Pregnant or nursing patients due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
6. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tumor Treatment Fields; 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; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	approximately 14-28 days

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: NovoCure Ltd.
• Investigators: Principal Investigator: John Waters, MD, University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: August 9, 2024
• First Submitted That Met QC Criteria: August 9, 2024
• First Posted (Actual): August 13, 2024

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: SCCC 07524; STU-2024-0624

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No