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

Adenocarcinoma of Lung Clinical Trial

Official title:

A Prospective Clinical Trial of Tumor Immunomodulation Using Tumor-Treating Fields (TTFields) in Patients With Early-Stage Resectable Lung Adenocarcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05764954
• Other study ID #: 22-387
• Status: Recruiting
• Phase: Phase 1
• Start date: August 4, 2023
• Est. completion date: August 2027

Study information

• Verified date: August 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Prasad Adusumilli, MD
• Phone: 212-639-8093
• Email: adusumip[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: August 2027
• Est. primary completion date: August 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Lung

Intervention

Device:
• NovoTTF-200T System
The device is applied continuously for an average duration of 18 hours per day for 3 weeks (+/- 1 week).

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (Consent Only)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Suffolk - Commack (Consent Only)	Commack	New York
United States	Memorial Sloan Kettering Westchester (Consent Only)	Harrison	New York
United States	Memorial Sloan Kettering Monmouth (Consent Only)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (Consent Only)	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York
United States	Memorial Sloan Kettering Nassau (Consent Only)	Uniondale	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	NovoCure Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events, severity and frequency	based on Common Terminology Criteria for Adverse Events (CTCAE) version 5.0	1 year

External Links

•   Memorial Sloan Kettering Cancer Center