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

NCT ID: NCT05764954

Last Updated: 2025-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-04

Study Completion Date

2027-08-31

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.

Detailed Description

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Conditions

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Adenocarcinoma of Lung

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

NovoTTF-200T System

Intervention Type DEVICE

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

Interventions

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NovoTTF-200T System

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

Intervention Type DEVICE

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 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
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NovoCure Ltd.

INDUSTRY

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Prasad Adusumilli, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Basking Ridge (Consent Only)

Basking Ridge, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Monmouth (Consent Only)

Middletown, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Bergen (Consent Only)

Montvale, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Suffolk - Commack (Consent Only)

Commack, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Westchester (Consent Only)

Harrison, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Nassau (Consent Only)

Uniondale, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Prasad Adusumilli, MD

Role: CONTACT

212-639-8093

Matthew Bott, MD

Role: CONTACT

212-639-5944

Facility Contacts

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Prasad J Adusumilli, MD

Role: primary

212-639-8093

Prasad Adusumilli, MD

Role: primary

212-639-8093

Prasad Adusumilli, MD

Role: primary

212-639-8093

Prasad Adusumilli, MD

Role: primary

212-639-8093

Prasad Adusumilli, MD

Role: primary

212-639-8093

Prasad Adusumilli, MD

Role: primary

212-639-8093

Matthew Bott, MD

Role: backup

212-639-5944

Prasad Adusumilli, MD

Role: primary

212-639-8093

Related Links

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http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan Kettering Cancer Center

Other Identifiers

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22-387

Identifier Type: -

Identifier Source: org_study_id

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