Status:
NOT_YET_RECRUITING
Pre-operative Tumor Treating Fields in Patients With Resectable Lung Cancer
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
NovoCure Ltd.
Conditions:
NSCLC
Non Small Cell Lung Cancer
Eligibility:
All Genders
22+ years
Phase:
NA
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). TTFiel...
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06552000
Start Date
December 1 2025
End Date
December 1 2029
Last Update
September 24 2025
Active Locations (1)
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1
The University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390