A Study of Tumor-Treating Fields (TTFields) in People With Lung Adenocarcinoma
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: NovoTTF-200T System Tumor-Treating Fields (TTFields) 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
The device is applied continuously for an average duration of 18 hours per day for 3 weeks (+/- 1 week).
|
Outcome Measures
Primary Outcome Measures
- Adverse events, severity and frequency [1 year]
based on Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Eligibility Criteria
Criteria
Inclusion Criteria:
-
The participant (or legally acceptable representative [LAR], if applicable) provides written informed consent for the study.
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The participant is ≥22 years of age on the day of signing informed consent.
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The participant has clinical stage IA3 or IB biopsy-proven lung ADC and is eligible for anatomical resection.
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The participant has a lung nodule >2 cm and suspected lung ADC with a plan to undergo biopsy.
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The participant with multiple nodules has one nodule that meets the criteria.
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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:
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Patients receiving therapy for concurrent active malignancy
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Patients with a history of cardiac arrhythmias and/or pacemaker use
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Patients with lung nodules <2cm
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Patients with lung nodules that are pure ground glass opacities (GGOs) of any size
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Patients with lung nodules that are <50% solid of any size
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Memorial Sloan Kettering Basking Ridge (Consent Only) | Basking Ridge | New Jersey | United States | 07920 |
| 2 | Memorial Sloan Kettering Monmouth (Consent Only) | Middletown | New Jersey | United States | 07748 |
| 3 | Memorial Sloan Kettering Bergen (Consent Only) | Montvale | New Jersey | United States | 07645 |
| 4 | Memorial Sloan Kettering Suffolk - Commack (Consent Only) | Commack | New York | United States | 11725 |
| 5 | Memorial Sloan Kettering Westchester (Consent Only) | Harrison | New York | United States | 10604 |
| 6 | Memorial Sloan Kettering Cancer Center (All Protocol Activities) | New York | New York | United States | 10065 |
| 7 | Memorial Sloan Kettering Nassau (Consent Only) | Uniondale | New York | United States | 11553 |
Sponsors and Collaborators
- Memorial Sloan Kettering Cancer Center
- NovoCure Ltd.
Investigators
- Principal Investigator: Prasad Adusumilli, MD, Memorial Sloan Kettering Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 22-387