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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Enrolling; Phase 1

Conditions: Adenocarcinoma of Lung

Treatments: Device: NovoTTF-200T System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05764954

22-387

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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 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.

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

NovoTTF-200T System Tumor-Treating Fields (TTFields)

Experimental group

Description:

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).

Treatment:

Device: NovoTTF-200T System