Using Tumor-Treating Fields for Lung Adenocarcinoma Treatment

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

This study is testing a device that uses Tumor-Treating Fields to see if it can help people with lung adenocarcinoma before they have surgery.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: Memorial Sloan Kettering Cancer Center (Academic / other)
• Locations: 7 sites (Basking Ridge, New Jersey and 6 other locations)
• Trial ID: NCT05764954 on ClinicalTrials.gov

What this trial studies

This study investigates the safety and feasibility of using the NovoTTF-200T System, a device that delivers Tumor-Treating Fields (TTFields), in patients with lung adenocarcinoma prior to surgical resection. The researchers aim to evaluate how this treatment may enhance the immune response against cancer. Participants will be closely monitored for any adverse effects and the overall practicality of this approach in a clinical setting.

Who should consider this trial

Good fit: Ideal candidates are adults aged 22 and older with biopsy-proven clinical stage 1A2, 1A3, or IB lung adenocarcinoma who are eligible for surgical resection.

Not a fit: Patients with concurrent active malignancies, those with a history of cardiac arrhythmias, or those with lung nodules smaller than 1 cm will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a novel non-invasive option to improve outcomes for patients with lung adenocarcinoma.

How similar studies have performed: While the use of TTFields is a relatively novel approach in lung cancer treatment, similar studies in other cancer types have shown promising results.

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

Where this trial is running

Basking Ridge, New Jersey and 6 other locations

• Memorial Sloan Kettering Basking Ridge (Consent Only) — Basking Ridge, New Jersey, United States (Recruiting)
• Memorial Sloan Kettering Monmouth (Consent Only) — Middletown, New Jersey, United States (Recruiting)
• Memorial Sloan Kettering Bergen (Consent Only) — Montvale, New Jersey, United States (Recruiting)
• Memorial Sloan Kettering Suffolk - Commack (Consent Only) — Commack, New York, United States (Recruiting)
• Memorial Sloan Kettering Westchester (Consent Only) — Harrison, New York, United States (Recruiting)
• Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (Recruiting)
• Memorial Sloan Kettering Nassau (Consent Only) — Uniondale, New York, United States (Recruiting)

Study contacts

• Principal investigator: Prasad Adusumilli, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Prasad Adusumilli, MD

Conditions Adenocarcinoma of Lung; NOVOTTF-200T system; TTFields treatment; 22-387