Tumor Treating Fields for Lung Cancer

Overseen By Ebele Mbanugo, Ed.D, CCRP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Prior NSCLC therapy, Neoadjuvant therapy, Allergic reactions, Uncontrolled illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 2-4 weeks

18 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the Tumor Treating Fields treatment for lung cancer?

The Tumor Treating Fields (TTFields) treatment uses electric fields to disrupt cancer cell processes and has shown promise when used with taxanes, a type of chemotherapy, in treating certain cancers. This combination may enhance the effectiveness of standard cancer treatments without adding significant side effects. ^{1 2 3 4 5}

How is the NovoTTF-200T System treatment different from other lung cancer treatments?

The NovoTTF-200T System is unique because it uses low-intensity, alternating electric fields to disrupt cancer cell division, a completely new approach compared to traditional treatments like chemotherapy or radiation. This non-invasive treatment is delivered through a portable device with transducer arrays placed on the body, offering a novel way to target tumors without the side effects of drugs. ^{6 7 8 9 10}

What is the purpose of this trial?

The purpose of this study is to study the clinical and biologic effects of Tumor Treatment Fields (TTFields) in patients undergoing resection of stage I-IIIA Non-Small Cell Lung Cancer (NSCLC). TTField is a non-invasive treatment that uses low-intensity electrical fields to treat cancer. Resection is the medical term for surgically removing part or all of a tissue, structure, or organ.

Research Team

John Waters, MD

Principal Investigator

UT Southwestern Medical Center

Eligibility Criteria

This trial is for individuals with early-stage (I-IIIA) Non-Small Cell Lung Cancer who are candidates for surgery to remove the cancer. Participants should be able to undergo the TTFields treatment before their surgery.

Inclusion Criteria

I am able to care for myself and up to being unable to work but can still move around.

Ability to understand and the willingness to sign a written informed consent

Willingness and ability to undergo planned correlative studies, including imaging tests

Exclusion Criteria

I am not pregnant or breastfeeding.

I am scheduled for initial treatment before surgery for my lung cancer.

History of major allergic reactions attributed to adhesive or compounds in TTFields micro-array

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Tumor Treatment Fields (TTFields) for 18 hours/day on average, continuously between time of enrollment and date of surgery

2-4 weeks

5 visits (in-person) over 2 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• NovoTTF-200T System

Trial Overview The study is testing the NovoTTF-200T System, a non-invasive device that delivers low-intensity electrical fields (TTFields) aimed at treating lung cancer by disrupting cancer cell division.

Participant Groups

Group I: Tumor Treatment Fields Experimental Treatment 1 Intervention

Duration: 2-4 week; target 18 hours/day (on average). Continuous between time of enrollment and date of surgery. Cycle Length: 2-4 weeks

NovoTTF-200T System is already approved in United States, European Union for the following indications:

Approved in United States as NovoTTF-200T System for:

• Glioblastoma multiforme (GBM)
• Malignant pleural mesothelioma (MPM)
• Breakthrough designation for unresectable or metastatic liver cancer

Approved in European Union as Optune for:

• Glioblastoma multiforme (GBM)

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

NovoCure Ltd.

Industry Sponsor

Trials

64

Recruited

6,100+

Ashley Cordova

NovoCure Ltd.

Chief Executive Officer

Bachelor of Science in Material Engineering from Ben-Gurion University of the Negev, Israel

Uri Weinberg

NovoCure Ltd.

Chief Medical Officer since 2020

MD from an unspecified institution

Findings from Research

Tumor Treating Fields (TTFields) therapy is a noninvasive treatment that uses electric fields to disrupt cancer cell processes, showing promise in enhancing the efficacy of standard chemotherapy without increasing systemic toxicity.

TTFields therapy primarily causes manageable localized skin reactions, making it a safer option to combine with other treatments like taxanes for cancers such as non-small cell lung cancer, ovarian cancer, and pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tumor Treating Fields (TTFields) Therapy Concomitant with Taxanes for Cancer Treatment. Vergote, I., Macarulla, T., Hirsch, FR., et al.[2023]

Surgery is a potentially curative treatment for non-small cell lung cancer (NSCLC) in stages I and II, and stage IIIA T3 tumors may also be operable with the help of preoperative chemotherapy to downstage the disease.

Postoperative chemotherapy is generally not recommended for stages I, II, and IIIA NSCLC, but cisplatin-based chemotherapy combined with radiotherapy is effective for stage IIIA N2, stage IIIB, and metastatic stage IV NSCLC, improving survival rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of non-small cell lung cancer according to staging--an update. Lam, WK.[2019]

Current standard treatment for advanced non-small-cell lung cancer involves doublet chemotherapy, which has shown 1-year survival rates of approximately 35% and 2-year survival rates of about 15%.

Preliminary studies indicate that triplet therapy may enhance survival rates compared to double therapy, with toxicity rates being low enough to support the development of these three-drug combinations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Triplet combination chemotherapy and targeted therapy regimens. Bunn, PA.[2005]

The NovoTTF-100A device, which delivers low-intensity electric fields, showed comparable efficacy to traditional chemotherapy in treating recurrent glioblastoma, with a median survival of 6.6 months for TTF compared to 6.0 months for chemotherapy, although this difference was not statistically significant.

Patients using the TTF device experienced fewer severe adverse events (6%) compared to those receiving chemotherapy (16%), and quality of life assessments generally favored the TTF treatment, indicating it may be a safer alternative for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NovoTTF-100A versus physician's choice chemotherapy in recurrent glioblastoma: a randomised phase III trial of a novel treatment modality. Stupp, R., Wong, ET., Kanner, AA., et al.[2022]

Tumor Treating Fields (TTF) have been shown to effectively inhibit tumor growth in glioblastoma (GBM) by disrupting mitosis and inducing cell death, with clinical trials demonstrating improved progression-free and overall survival when combined with standard chemotherapy.

TTF treatment is non-invasive and has minimal systemic toxicity, making it a safe option for patients with GBM, as evidenced by randomized phase III trials that showed no significant adverse events compared to traditional chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tumor treating fields: a novel and effective therapy for glioblastoma: mechanism, efficacy, safety and future perspectives. Zhu, P., Zhu, JJ.[2018]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Tumor Treating Fields (TTFields) Therapy Concomitant with Taxanes for Cancer Treatment. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Adjuvant and neoadjuvant chemotherapy for non-small cell lung cancer: a time for reassessment? [2019]

3. Australia pubmed.ncbi.nlm.nih.gov

Management of non-small cell lung cancer according to staging--an update. [2019]

4. Japan pubmed.ncbi.nlm.nih.gov

[Targeting therapy for lung cancer]. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Triplet combination chemotherapy and targeted therapy regimens. [2005]

6. England pubmed.ncbi.nlm.nih.gov

NovoTTF-100A versus physician's choice chemotherapy in recurrent glioblastoma: a randomised phase III trial of a novel treatment modality. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Tumor treating fields - an emerging cancer treatment modality. [2013]

8. England pubmed.ncbi.nlm.nih.gov

NovoTTF™-100A System (Tumor Treating Fields) transducer array layout planning for glioblastoma: a NovoTAL™ system user study. [2018]

9. China pubmed.ncbi.nlm.nih.gov

Tumor treating fields: a novel and effective therapy for glioblastoma: mechanism, efficacy, safety and future perspectives. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Combination therapy of Doxorubicin with TTFields and radiation: newer approaches to combat lung cancer. [2022]