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

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

Study Overview

• Status: Recruiting
• Conditions: Adenocarcinoma of Lung
• Intervention / Treatment: Device: NovoTTF-200T System

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Prasad Adusumilli, MD; Phone Number: 212-639-8093; Email: adusumip@mskcc.org
• Study Contact Backup: Name: Matthew Bott, MD; Phone Number: 212-639-5944

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Recruiting
      • Memorial Sloan Kettering Basking Ridge (Consent only)
      • Contact: Prasad J Adusumilli, MD; Phone Number: 212-639-8093
    • Middletown, New Jersey, United States, 07748
      • Recruiting
      • Memorial Sloan Kettering Monmouth (Consent only)
      • Contact: Prasad Adusumilli, MD; Phone Number: 212-639-8093
    • Montvale, New Jersey, United States, 07645
      • Recruiting
      • Memorial Sloan Kettering Bergen (Consent only)
      • Contact: Prasad Adusumilli, MD; Phone Number: 212-639-8093
  • New York
    • Commack, New York, United States, 11725
      • Recruiting
      • Memorial Sloan Kettering Suffolk - Commack (Consent only)
      • Contact: Prasad Adusumilli, MD; Phone Number: 212-639-8093
    • Harrison, New York, United States, 10604
      • Recruiting
      • Memorial Sloan Kettering Westchester (Consent only)
      • Contact: Prasad Adusumilli, MD; Phone Number: 212-639-8093
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
      • Contact: Matthew Bott, MD; Phone Number: 212-639-5944
      • Contact: Prasad Adusumilli, MD; Phone Number: 212-639-8093
      • Principal Investigator: Prasad Adusumilli, MD
    • Uniondale, New York, United States, 11553
      • Recruiting
      • Memorial Sloan Kettering Nassau (Consent only)
      • Contact: Prasad Adusumilli, MD; Phone Number: 212-639-8093

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NovoTTF-200T System Tumor-Treating Fields (TTFields); 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; The device is applied continuously for an average duration of 18 hours per day for 3 weeks (+/- 1 week).

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: NovoCure Ltd.
• Investigators: Principal Investigator: Prasad Adusumilli, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2023
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: February 22, 2023
• First Submitted That Met QC Criteria: March 3, 2023
• First Posted (Actual): March 13, 2023

Study Record Updates

• Last Update Posted (Actual): August 7, 2023
• Last Update Submitted That Met QC Criteria: August 4, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: NOVOTTF-200T system; TTFields treatment; 22-387
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Adenocarcinoma; Adenocarcinoma of Lung
• Other Study ID Numbers: 22-387

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes