Back to resultsA Study of Tumor-Treating Fields (TTFields) in People With Lung Adenocarcinoma
Primary Purpose
Adenocarcinoma of Lung
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NovoTTF-200T System
Sponsored by
About this trial
This is an interventional treatment trial for Adenocarcinoma of Lung focused on measuring NOVOTTF-200T system, TTFields treatment, 22-387
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 IA3 or IB biopsy-proven lung ADC and is eligible for anatomical resection. The participant has a lung nodule >2 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 (with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or in situ cervical cancer) 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 <2cm 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
Sites / Locations
- Memorial Sloan Kettering Basking Ridge (Consent Only)Recruiting
- Memorial Sloan Kettering Monmouth (Consent Only)Recruiting
- Memorial Sloan Kettering Bergen (Consent Only)Recruiting
- Memorial Sloan Kettering Suffolk - Commack (Consent Only)Recruiting
- Memorial Sloan Kettering Westchester (Consent Only)Recruiting
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting
- Memorial Sloan Kettering Nassau (Consent Only)Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NovoTTF-200T System Tumor-Treating Fields (TTFields)
Arm Description
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).
Outcomes
Primary Outcome Measures
Adverse events, severity and frequency
based on Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Secondary Outcome Measures
Full Information
NCT ID
NCT05764954
First Posted
February 22, 2023
Last Updated
August 4, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
NovoCure Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05764954
Brief Title
A Study of Tumor-Treating Fields (TTFields) in People With Lung Adenocarcinoma
Official Title
A Prospective Clinical Trial of Tumor Immunomodulation Using Tumor-Treating Fields (TTFields) in Patients With Early-Stage Resectable Lung Adenocarcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 4, 2023 (Actual)
Primary Completion Date
August 2027 (Anticipated)
Study Completion Date
August 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
NovoCure Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of Lung
Keywords
NOVOTTF-200T system, TTFields treatment, 22-387
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NovoTTF-200T System Tumor-Treating Fields (TTFields)
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
NovoTTF-200T System
Intervention Description
The device is applied continuously for an average duration of 18 hours per day for 3 weeks (+/- 1 week).
Primary Outcome Measure Information:
Title
Adverse events, severity and frequency
Description
based on Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
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 IA3 or IB biopsy-proven lung ADC and is eligible for anatomical resection.
The participant has a lung nodule >2 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 (with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or in situ cervical cancer) 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 <2cm
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Prasad Adusumilli, MD
Phone
212-639-8093
Email
adusumip@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Bott, MD
Phone
212-639-5944
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prasad Adusumilli, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Basking Ridge (Consent Only)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prasad J Adusumilli, MD
Phone
212-639-8093
Facility Name
Memorial Sloan Kettering Monmouth (Consent Only)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prasad Adusumilli, MD
Phone
212-639-8093
Facility Name
Memorial Sloan Kettering Bergen (Consent Only)
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prasad Adusumilli, MD
Phone
212-639-8093
Facility Name
Memorial Sloan Kettering Suffolk - Commack (Consent Only)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prasad Adusumilli, MD
Phone
212-639-8093
Facility Name
Memorial Sloan Kettering Westchester (Consent Only)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prasad Adusumilli, MD
Phone
212-639-8093
Facility Name
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prasad Adusumilli, MD
Phone
212-639-8093
First Name & Middle Initial & Last Name & Degree
Matthew Bott, MD
Phone
212-639-5944
First Name & Middle Initial & Last Name & Degree
Prasad Adusumilli, MD
Facility Name
Memorial Sloan Kettering Nassau (Consent Only)
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prasad Adusumilli, MD
Phone
212-639-8093
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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
Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center
Learn more about this trial
A Study of Tumor-Treating Fields (TTFields) in People With Lung Adenocarcinoma
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