Non Small Cell Lung Cancer, NSCLC
Conditions
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 .
Interventions
DEVICENovoTTF-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)
Sponsors
University of Texas Southwestern Medical Center
NovoCure Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTEbele Mbanugo, Ed.D, CCRP
PRINCIPAL_INVESTIGATORJohn Waters, MD
University of Texas Southwestern Medical Center
Outcome results
None listed