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

Not Applicable

Not yet recruiting

• Conditions: NSCLC; Non Small Cell Lung Cancer
• Interventions: Device: NovoTTF-200T System

• Registration Number: NCT06552000
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

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 Timeline

• Study First Submitted: 2024-08-09
• Study First Submitted QC: 2024-08-09
• Study First Posted: 2024-08-13
• Status Verified: 2025-01
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-03-28
• Study Start: 2025-05-31
• Primary Completion: 2027-12-01
• Study Completion: 2029-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tumor Treatment Fields	NovoTTF-200T System	Duration: 2-4 week; target 18 hours/day (on average). Continuous between time of enrollment and date of surgery. Cycle Length: 2-4 weeks

Primary Outcome Measures

Name	Time	Method
Effect of TTF (Tumor-Treating Fields) on Fanconi anemia-related genes.	approximately 14-28 days	Determine the effect of TTFields on expression of Fanconi anemia pathway-associated genes in NSCLC.

Secondary Outcome Measures

Name	Time	Method
Safety of administering TTFields	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.

Trial Locations

Locations (1)

The University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States