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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Contact
Study Contact
- Name: Prasad Adusumilli, MD
- Phone Number: 212-639-8093
- Email: adusumip@mskcc.org
Study Contact Backup
- Name: Matthew Bott, MD
- Phone Number: 212-639-5944
Study Locations
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New Jersey
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Basking Ridge, New Jersey, United States, 07920
- Memorial Sloan Kettering Basking Ridge (Consent Only)
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Middletown, New Jersey, United States, 07748
- Memorial Sloan Kettering Monmouth (Consent only)
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Montvale, New Jersey, United States, 07645
- Memorial Sloan Kettering Bergen (Consent Only)
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New York
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Commack, New York, United States, 11725
- Memorial Sloan Kettering Suffolk - Commack (Consent Only)
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Harrison, New York, United States, 10604
- Memorial Sloan Kettering Westchester (Consent Only)
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)
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Uniondale, New York, United States, 11553
- Memorial Sloan Kettering Nassau (Consent Only)
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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).
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The device is applied continuously for an average duration of 18 hours per day for 3 weeks (+/- 1 week).
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adverse events, severity and frequency
Time Frame: 1 year
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based on Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
|
1 year
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Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Prasad Adusumilli, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 22-387
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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