Clinical trial NCT05764954: 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
Overall status: RECRUITING
Phase: PHASE1
Conditions: Adenocarcinoma of Lung
Keywords: NOVOTTF-200T system
TTFields treatment
22-387
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: NovoCure Ltd.
First posted: 2023-03-13
Enrollment: 25
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Adverse events, severity and frequency
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Consent Only)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Consent Only)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Consent Only)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk - Commack (Consent Only)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Consent Only)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Consent Only)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Prasad Adusumilli, MD
role: PRINCIPAL_INVESTIGATOR
References: