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Trial Title:
A Study of Tumor-Treating Fields (TTFields) in People With Lung Adenocarcinoma
NCT ID:
NCT05764954
Condition:
Adenocarcinoma of Lung
Conditions: Official terms:
Adenocarcinoma
Adenocarcinoma of Lung
Conditions: Keywords:
NOVOTTF-200T system
TTFields treatment
22-387
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
NovoTTF-200T System
Description:
The device is applied continuously for an average duration of 18 hours per day for 3
weeks (+/- 1 week).
Arm group label:
NovoTTF-200T System Tumor-Treating Fields (TTFields)
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
22 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Basking Ridge (Consent Only)
Address:
City:
Basking Ridge
Zip:
07920
Country:
United States
Status:
Recruiting
Contact:
Last name:
Prasad J Adusumilli, MD
Phone:
212-639-8093
Facility:
Name:
Memorial Sloan Kettering Monmouth (Consent Only)
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Contact:
Last name:
Prasad Adusumilli, MD
Phone:
212-639-8093
Facility:
Name:
Memorial Sloan Kettering Bergen (Consent Only)
Address:
City:
Montvale
Zip:
07645
Country:
United States
Status:
Recruiting
Contact:
Last name:
Prasad Adusumilli, MD
Phone:
212-639-8093
Facility:
Name:
Memorial Sloan Kettering Suffolk - Commack (Consent Only)
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Contact:
Last name:
Prasad Adusumilli, MD
Phone:
212-639-8093
Facility:
Name:
Memorial Sloan Kettering Westchester (Consent Only)
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Prasad Adusumilli, MD
Phone:
212-639-8093
Facility:
Name:
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Prasad Adusumilli, MD
Phone:
212-639-8093
Contact backup:
Last name:
Matthew Bott, MD
Phone:
212-639-5944
Investigator:
Last name:
Prasad Adusumilli, MD
Email:
Principal Investigator
Facility:
Name:
Memorial Sloan Kettering Nassau (Consent Only)
Address:
City:
Uniondale
Zip:
11553
Country:
United States
Status:
Recruiting
Contact:
Last name:
Prasad Adusumilli, MD
Phone:
212-639-8093
Start date:
August 4, 2023
Completion date:
August 2027
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Collaborator:
Agency:
NovoCure Ltd.
Agency class:
Industry
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05764954
http://www.mskcc.org/mskcc/html/44.cfm
