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TTFields for Lung Cancer

Phase 1

Recruiting

Led By Prasad Adusumilli, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The participant has clinical stage IA3 or IB biopsy-proven lung ADC and is eligible for anatomical resection.

The participant is ≥22 years of age on the day of signing informed consent.

Must not have

Patients with lung nodules that are <50% solid of any size

Patients receiving therapy for concurrent active malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if a new treatment for lung cancer is safe and effective, and could help the body fight it.

Who is the study for?

This trial is for adults over 22 with a specific lung cancer called adenocarcinoma, who are eligible for surgery to remove it. They must have a tumor larger than 2 cm and no history of other cancers (with some exceptions) in the last five years. It's not for those with certain heart issues, pacemakers, very small or less solid tumors, or active treatment for another cancer.

What is being tested?

The study tests the NovoTTF-200T System which uses Tumor-Treating Fields (TTFields) before surgery on lung adenocarcinoma patients. The goal is to see if this method is safe and doable, and how it might boost the body's own fight against cancer.

What are the potential side effects?

While specific side effects aren't listed here, TTFields therapy generally can cause skin irritation under device electrodes, headaches, malaise and muscle twitching. Each person may experience these differently.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung cancer is at an early stage and I can have surgery to remove it.

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I am 22 years old or older.

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I have a lung nodule larger than 2 cm and am scheduled for a biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My lung nodules are less than half solid.

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I am currently being treated for another cancer.

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My lung scans show areas that are completely 'foggy' looking.

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I have a history of heart rhythm problems or use a pacemaker.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse events, severity and frequency

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: NovoTTF-200T System Tumor-Treating Fields (TTFields)Experimental Treatment1 Intervention

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).

0 / 7Eligibility criteria met