A Study of Tumor-Treating Fields (TTFields) in People With Lung Adenocarcinoma
- Conditions
- Adenocarcinoma of Lung
- Interventions
- Device: NovoTTF-200T System
- Registration Number
- NCT05764954
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Brief Summary
The researchers are doing this study to find out if treatment with TTFields using the NovoTTF-200T System is safe and practical (feasible) before surgical removal (resection) of lung adenocarcinoma (ADC). The researchers will also look at how the treatment may help the body's immune system to fight cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 25
- The participant (or legally acceptable representative [LAR], if applicable) provides written informed consent for the study.
- The participant is ≥22 years of age on the day of signing informed consent.
- The participant has clinical stage 1A2, 1A3 or IB biopsy-proven lung ADC and is eligible for anatomical resection.
- The participant has a lung nodule >1 cm and suspected lung ADC with a plan to undergo biopsy.
- The participant with multiple nodules has one nodule that meets the criteria.
- The participant has no history of prior malignancy in the chest or has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
- Patients receiving therapy for concurrent active malignancy
- Patients with a history of cardiac arrhythmias and/or pacemaker use
- Patients with lung nodules <1cm
- Patients with lung nodules that are pure ground glass opacities (GGOs) of any size
- Patients with lung nodules that are <50% solid of any size
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description NovoTTF-200T System Tumor-Treating Fields (TTFields) NovoTTF-200T System Following pathological confirmation on of lung ADC, patients will proceed with TTFields treatment. The NovoTTF-200T System is an investigational medical device delivering 150 kHz TTFields to the patient's chest. The device is applied continuously for an average duration of 18 hours per day for 3 weeks (+/- 1 week).
- Primary Outcome Measures
Name Time Method Adverse events, severity and frequency 1 year based on Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Memorial Sloan Kettering Nassau (Consent Only)
🇺🇸Uniondale, New York, United States
Memorial Sloan Kettering Westchester (Consent Only)
🇺🇸Harrison, New York, United States
Memorial Sloan Kettering Bergen (Consent Only)
🇺🇸Montvale, New Jersey, United States
Memorial Sloan Kettering Basking Ridge (Consent Only)
🇺🇸Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Consent Only)
🇺🇸Middletown, New Jersey, United States
Memorial Sloan Kettering Suffolk - Commack (Consent Only)
🇺🇸Commack, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
🇺🇸New York, New York, United States