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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effects of Tumor Treatment Fields (TTFields), a non-invasive therapy using low-intensity electrical fields to treat cancer, in individuals with early-stage non-small cell lung cancer (NSCLC) scheduled for surgery. The researchers aim to determine whether TTFields can shrink tumors or improve surgical outcomes. Participants will use a device called the NovoTTF-200T System for 2-4 weeks before surgery. This trial may suit those diagnosed with stage I-IIIA NSCLC who plan to have part or all of their lung surgically removed. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research in cancer treatment.

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 prior data suggests that Tumor Treatment Fields are safe for treating lung cancer?

Studies have shown that Tumor Treating Fields (TTFields) are generally easy for patients to manage. Research indicates that the NovoTTF-200T System, used for treating non-small cell lung cancer, does not typically cause side effects that affect the entire body. It targets cancer cells specifically, sparing other parts of the body.

Additionally, the FDA has approved the related Optune Lua device, which uses similar technology, for treating a different stage of lung cancer. This approval suggests safety, as testing has confirmed it is safe for some patients. However, TTFields for this specific use are still under study, so discussing any concerns with the medical team is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for lung cancer, which typically involve chemotherapy, radiation, or surgery, the NovoTTF-200T System offers a unique approach by using Tumor Treating Fields (TTFields). TTFields are low-intensity electric fields that disrupt cancer cell division without harming healthy cells. Researchers are excited about this treatment because it provides a non-invasive way to target tumors continuously, potentially reducing side effects and improving quality of life for patients. This innovative mechanism of action sets it apart from traditional therapies, offering hope for better outcomes in lung cancer treatment.

What evidence suggests that Tumor Treatment Fields might be an effective treatment for lung cancer?

Research shows that Tumor Treating Fields (TTFields), which participants in this trial will receive, can help treat non-small cell lung cancer (NSCLC). Past studies found that TTFields enhance the effectiveness of chemotherapy in both lab tests and real-life situations. This non-invasive treatment uses gentle electrical fields to stop cancer cells from dividing, eliminating the need for surgery. The FDA has approved a similar device, Optune Lua, for advanced NSCLC, highlighting its effectiveness. Patients using TTFields have achieved good results when combined with other treatments like immune checkpoint inhibitors. This suggests that TTFields could also benefit patients with early-stage NSCLC. ^{2 3 6 7 8}

Who Is on the Research Team?

John Waters, MD

Principal Investigator

UT Southwestern Medical Center

Are You a Good Fit for This Trial?

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

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

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

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

Exclusion Criteria

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

I am not pregnant or breastfeeding.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11807771/

Estimating the Cost-Effectiveness of Tumor Treating Fields ... This study evaluates the cost-effectiveness of TTFields therapy concomitant with immune checkpoint inhibitors (ICIs) or docetaxel.

2. novocuretrials.com novocuretrials.com/cancer-clinical-trials/non-small-cell-lung-cancer-clinical-trial-lunar

LUNAR - NSCLC Clinical Trial LUNAR is a cancer clinical trial intended for lung cancer patients interested in participating in a clinical study that uses Novocure's TTFields technology.

3. novocure.com novocure.com/fda-approves-novocures-optune-lua-for-the-treatment-of-metastatic-non-small-cell-lung-cancer

FDA Approves Novocure's Optune Lua® for the Treatment ... The first treatment of its kind for metastatic NSCLC, Optune Lua is approved for use concurrently with PD-1/PD-L1 inhibitors or docetaxel in ...

4. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/P230042C.pdf

Optune LuaTM for Non-Small Cell Lung Cancer (NSCLC) ... Optune Lua is a portable, battery-powered or mains-powered device that produces alternating electrical fields, called tumor treating fields (“TTFields”) within ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02973789

NCT02973789 | Effect of Tumor Treating Fields (TTFields) ... Alternating electric fields (tumor-treating fields therapy) can improve chemotherapy treatment efficacy in non-small cell lung cancer both in vitro and in vivo.

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/P230042b.pdf

Tumor Treatment Fields II. Device Tr - accessdata.fda.gov The simulations showed that for all models, Optune Lua delivers therapeutic intensities of over 0.7 V/cm RMS to over at least 76% of the lungs.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12055647/

Tumor Treating Fields (TTFields) Therapy in Unresectable ... Patients received continuous TTFields therapy at a frequency of 150 kHz with the NovoTTF- 100L system, for a planned duration of at least 18 h ...

8. novocuretrials.com novocuretrials.com/cancer-clinical-trials/lung-cancer-clinical-trials-keynote-b36

KEYNOTE B36 - Lung Cancer Clinical Trial NovoTTF-200T for the treatment of non-small cell lung cancer is investigational; it has not been approved by the U.S. Food and Drug Administration (FDA). The ...