A Study of Tumor-Treating Fields (TTFields) in People With Lung Adenocarcinoma

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Clinical Trial of Tumor Immunomodulation Using Tumor-Treating Fields (TTFields) in Patients With Early-Stage Resectable Lung Adenocarcinoma

Conditions
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Adenocarcinoma of Lung

Intervention / Treatment
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* Device: NovoTTF-200T System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 IA3 or IB biopsy-proven lung ADC and is eligible for anatomical resection. The participant has a lung nodule >2 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 (with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or in situ cervical cancer) or has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy. Exclusion Criteria: Patients receiving therapy for concurrent active malignancy Patients with a history of cardiac arrhythmias and/or pacemaker use Patients with lung nodules <2cm 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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NovoTTF-200T System Tumor-Treating Fields (TTFields)<br>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). | Device: NovoTTF-200T System<br>* The device is applied continuously for an average duration of 18 hours per day for 3 weeks (+/- 1 week).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events, severity and frequency | based on Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NOVOTTF-200T system, TTFields treatment, 22-387