RecruitingPhase 1NCT05764954

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

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


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

25 participants

Start Date

Aug 4, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 22 Years

Inclusion Criteria6

  • 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 Criteria5

  • 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

Interventions

DEVICENovoTTF-200T System

The device is applied continuously for an average duration of 18 hours per day for 3 weeks (+/- 1 week).


Locations(7)

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 Bergen (Consent Only)

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk - Commack (Consent Only)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Consent Only)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (Consent Only)

Uniondale, New York, United States

View Full Details on ClinicalTrials.gov

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NCT05764954


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