A Study of Tumor-Treating Fields (TTFields) in People Wit... | NCT05764954

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

NCT05764954

Sponsor

Memorial Sloan Kettering Cancer Center

Status

Active, not recruiting

Last Update Posted

May 28, 2026Actual

Enrollment

12Actual

Phase

Phase 1

Conditions

Adenocarcinoma of Lung

Interventions

NovoTTF-200T System

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Aug 4, 2023Actual

Primary Completion Date

Aug 2027Estimated

Completion Date

Aug 2027Estimated

First Submitted Date

Feb 22, 2023

First Submission Date that Met QC Criteria

Mar 3, 2023

First Posted Date

Mar 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 27, 2026

Last Update Posted Date

May 28, 2026Actual

Name	Class
NovoCure Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NovoTTF-200T System Tumor-Treating Fields (TTFields)	Experimental	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).	Device: NovoTTF-200T System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NovoTTF-200T System	Device	The device is applied continuously for an average duration of 18 hours per day for 3 weeks (+/- 1 week).	NovoTTF-200T System Tumor-Treating Fields (TTFields)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse events, severity and frequency	based on Common Terminology Criteria for Adverse Events (CTCAE) version 5.0	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Prasad Adusumilli, MD	Memorial Sloan Kettering Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Memorial Sloan Kettering Basking Ridge (Consent Only)		Basking Ridge	New Jersey	07920	United States

Label	URL
Memorial Sloan Kettering Cancer Center	View source

IPD Sharing Statement Module

Plan to Share IPD

Yes

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000077192	Adenocarcinoma of Lung

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided