Clinical trial NCT06552000: Pre-operative Tumor Treating Fields in Patients With Resectable Lung Cancer
Official title: Phase 0 Trial of Pre-operative Tumor Treating Fields in Patients With Resectable Lung Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: NSCLC
Non Small Cell Lung Cancer
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: NovoCure Ltd.
First posted: 2024-08-13
Enrollment: 18
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 .

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.

Primary outcomes:
measure: Effect of TTF (Tumor-Treating Fields) on Fanconi anemia-related genes.
timeFrame: approximately 14-28 days
Secondary outcomes:
measure: Safety of administering TTFields
timeFrame: approximately 14-28 days
Other outcomes:
Locations:
city: Dallas
country: United States
facility: The University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: John Waters, MD
role: PRINCIPAL_INVESTIGATOR
References: