Clinical trial · Interventional
Pre-operative Tumor Treating Fields in Patients With Resectable Lung Cancer
Phase 0 Trial of Pre-operative Tumor Treating Fields in Patients With Resectable Lung Cancer
NCT06552000CI-TRIAL-00103814not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NovoTTF-200T System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tumor Treatment Fields
- description
- Duration: 2-4 week; target 18 hours/day (on average). Continuous between time of enrollment and date of surgery. Cycle Length: 2-4 weeks
- interventionNames
- Device: NovoTTF-200T System
Primary outcomes (1)
- measure
- Effect of TTF (Tumor-Treating Fields) on Fanconi anemia-related genes.
- timeFrame
- approximately 14-28 days
- description
- Determine the effect of TTFields on expression of Fanconi anemia pathway-associated genes in NSCLC.
Secondary outcomes (1)
- measure
- Safety of administering TTFields
- timeFrame
- approximately 14-28 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 22 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.