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

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

NCT ID: NCT06552000

Condition: NSCLC
Non Small Cell Lung Cancer

Conditions: Official terms:
Lung Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: NovoTTF-200T System
Description: 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)
Arm group label: Tumor Treatment Fields

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 .

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 22 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: The University of Texas Southwestern Medical Center

Address:
City: Dallas
Zip: 75390
Country: United States

Contact:
Last name: Ebele Mbanugo, Ed.D, CCRP

Phone: 214-645-0326
Email: ebele.mbanugo@utsouthwestern.edu

Investigator:
Last name: John Waters, MD
Email: Principal Investigator

Start date: December 1, 2024

Completion date: December 1, 2029

Lead sponsor:
Agency: University of Texas Southwestern Medical Center
Agency class: Other

Collaborator:
Agency: NovoCure Ltd.
Agency class: Industry

Source: University of Texas Southwestern Medical Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06552000