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OpenTrials
Active, Not Recruiting

NCT Number: NCT05764954

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Adenocarcinoma of Lung Adenocarcinoma Carcinoma Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Memorial Sloan Kettering Basking Ridge (Consent Only), Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NovoTTF-200T System

Device

The device is applied continuously for an average duration of 18 hours per day for 3 weeks (+/- 1 week).

Primary outcomes

  1. Adverse events, severity and frequency

    Time frame: 1 year

    based on Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • NovoCure Ltd.

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Mar 13, 2023
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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