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
1 other identifier
interventional
25
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2023
Longer than P75 for phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2023
CompletedFirst Posted
Study publicly available on registry
March 13, 2023
CompletedStudy Start
First participant enrolled
August 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
April 9, 2026
April 1, 2026
4 years
February 22, 2023
April 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse events, severity and frequency
based on Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
1 year
Study Arms (1)
NovoTTF-200T System Tumor-Treating Fields (TTFields)
EXPERIMENTALFollowing 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).
Interventions
The device is applied continuously for an average duration of 18 hours per day for 3 weeks (+/- 1 week).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Memorial Sloan Kettering Cancer Centerlead
- NovoCure Ltd.collaborator
Study Sites (7)
Memorial Sloan Kettering Basking Ridge (Consent Only)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Consent Only)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Consent Only)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Suffolk - Commack (Consent Only)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Consent Only)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Consent Only)
Uniondale, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Prasad Adusumilli, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2023
First Posted
March 13, 2023
Study Start
August 4, 2023
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
August 1, 2027
Last Updated
April 9, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org