TTFields for Lung Cancer

Recruiting at 6 trial locations

Overseen By Matthew Bott, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Active malignancy, Cardiac arrhythmias, Pacemaker, 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: Unknown

Duration: 3 weeks

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, the NovoTTF-200T System, to determine its safety and feasibility for individuals with lung adenocarcinoma (ADC) before surgery. The device uses Tumor-Treating Fields (TTFields) to target cancer cells, and researchers are also evaluating its potential to enhance the immune system's ability to fight cancer. Suitable candidates for this trial include those with biopsy-confirmed lung ADC, a lung nodule larger than 1 cm, and plans for surgical removal. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative treatment.

Will I have to stop taking my current medications?

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 the NovoTTF-200T System is safe for treating lung adenocarcinoma?

Research has shown that the NovoTTF-200T System, which uses Tumor Treating Fields (TTFields), has been tested for safety in treating various cancers, though it is still under study for lung cancer. Previous studies found the device to be generally safe, with most side effects being mild to moderate skin reactions at the application site.

The NovoTTF-200T System is currently undergoing tests for non-small cell lung cancer, but the FDA has not yet approved it for this purpose. As this trial is in an early stage, the main goal is to assess the treatment's safety and tolerability. While specific safety information for lung adenocarcinoma is limited, the device has shown potential in other conditions. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for lung cancer, which typically involves chemotherapy, radiation, or surgery, the NovoTTF-200T System offers a novel approach using Tumor-Treating Fields (TTFields). This investigational device delivers low-intensity, alternating electric fields directly to the chest to disrupt cancer cell division. Researchers are excited about this treatment because it provides a non-invasive option that can be used continuously for extended periods each day, potentially minimizing the side effects associated with traditional treatments.

What evidence suggests that the NovoTTF-200T System is effective for lung cancer?

Research has shown that the NovoTTF-200T System, which uses Tumor-Treating Fields (TTFields), may help treat lung cancer. In this trial, participants will receive the NovoTTF-200T System as an investigational treatment. Studies have found that it can greatly improve the survival of patients with non-small cell lung cancer (NSCLC). TTFields use gentle electric fields to target the tumor, stopping cancer cells from dividing. In earlier trials, patients using similar TTFields technology achieved better results when combined with chemotherapy. These findings suggest that TTFields could help the immune system fight lung adenocarcinoma effectively. ^{2 3 4 6 7}

Who Is on the Research Team?

Prasad Adusumilli, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I have no cancer history, except for certain skin, bladder, or cervical cancers, or I've been cancer-free for 5 years after treatment.

I am 22 years old or older.

Exclusion Criteria

My lung nodules are less than half solid.

I am currently being treated for another cancer.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TTFields treatment using the NovoTTF-200T System for an average of 18 hours per day

3 weeks

Continuous application

Surgery

Surgical removal (resection) of lung adenocarcinoma

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• NovoTTF-200T System

Trial Overview 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.

How Is the Trial Designed?

Group I: NovoTTF-200T System Tumor-Treating Fields (TTFields) Experimental Treatment 1 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).

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

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

In a Phase I-II study involving 19 patients with advanced non-small cell lung cancer (NSCLC), the maximum tolerated dose of Fotemustine was determined to be 75 mg/m2 over three consecutive days, but this regimen resulted in significant toxicity, including 25% of patients experiencing severe neutropenia and 31% severe thrombocytopenia.

Despite observing two partial responses in patients, the three-day administration schedule of Fotemustine was found to be less effective and more toxic compared to other treatment schedules, leading to the conclusion that the standard administration on days 1 and 8 remains the preferred method for NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I-II and pharmacokinetic study of a new fotemustine schedule in advanced non-small cell lung cancer. Le Cesne, A., Chabot, G., Bérille, J., et al.[2019]

In a study of 10 patients with metastatic non-small cell lung cancer (NSCLC), (18)F-FLT PET/CT imaging effectively measured tumor proliferation before and after treatment with tyrosine kinase inhibitors, showing a significant decrease in (18)F-FLT uptake at 7 and 28 days post-treatment.

Simplified quantitative measures like standardized uptake value (SUV) and tumor-to-blood ratio (TBR) were found to correlate well with more complex kinetic analyses, suggesting they can be reliable indicators of treatment response in NSCLC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of simplified methods to measure 18F-FLT uptake changes in EGFR-mutated non-small cell lung cancer patients undergoing EGFR tyrosine kinase inhibitor treatment. Frings, V., Yaqub, M., Hoyng, LL., et al.[2018]

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]

Recent advancements in the treatment of non-small-cell lung cancer (NSCLC) have made personalized therapies more feasible, particularly with the discovery of mutations in the epidermal growth factor receptor and anaplastic lymphoma kinase.

Erlotinib and crizotinib have been proven effective and safe for specific subgroups of NSCLC patients, and ongoing research into new tyrosine kinase inhibitors and detection systems aims to enhance the affordability and effectiveness of treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted therapy for lung cancer. Petrosyan, F., Daw, H., Haddad, A., et al.[2018]

The study analyzed the uptake of 18F-FLT in head and neck squamous cell carcinomas using dynamic PET imaging, finding that a three-tissue model provided a better fit for tumor time-activity curves than a two-tissue model, indicating improved accuracy in assessing tumor behavior.

The use of EM-BIC clustering helped simplify complex parametric maps, which could enhance the precision of radiotherapy planning, although it also revealed significant noise in phosphorylation rate-constant maps that needs to be addressed for better reliability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18F-FLT uptake kinetics in head and neck squamous cell carcinoma: a PET imaging study. Liu, D., Chalkidou, A., Landau, DB., et al.[2022]

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]

Concurrent chemoradiation is the standard treatment for locally advanced unresectable non-small-cell lung cancer, highlighting its efficacy as a major therapeutic option.

New radiotherapy techniques, such as respiratory gating and intensity-modulated radiotherapy, are being developed to improve treatment precision, while stereotactic and proton-beam therapies may offer better options for early-stage tumors in non-operable patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Radiotherapy for non-small cell lung cancer]. Girard, N., Mornex, F.[2009]

Intratracheal administration of αvβ3-integrin targeted perfluorocarbon (PFC) nanoparticles in a rabbit lung cancer model resulted in significantly higher concentrations of nanoparticles in tumors compared to intravenous administration.

The use of 19F MRI allowed for effective quantitative assessment of the distribution of these nanoparticles and the evaluation of tumor angiogenesis, demonstrating the feasibility and efficacy of this delivery method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

19F MRI in orthotopic cancer model via intratracheal administration of ανβ3-targeted perfluorocarbon nanoparticles. Xu, X., Zhang, R., Liu, F., et al.[2019]

In a phase II study involving 43 patients with advanced non-small-cell lung cancer (NSCLC), the novel drug fotemustine showed a partial response rate of 13.5%, indicating moderate efficacy in this patient population.

Fotemustine was generally well-tolerated, with the main side effects being mild anemia and thrombocytopenia, suggesting it has a manageable safety profile for treating NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II study of fotemustine in untreated inoperable non-small-cell lung cancer. Rudd, R., Allen, R., Berille, J., et al.[2019]

Citations

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

Tumor Treating Fields (TTFields) Therapy in Unresectable ... TTFields therapy represents a novel and clinically versatile therapeutic option in the battle against pleural mesothelioma without introducing additional ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02973789

NCT02973789 | Effect of Tumor Treating Fields (TTFields) ... The effect of treatment compliance with NovoTTF-200T on overall survival and progression free survival outcomes, 4 years. Adverse events, severity and ...

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

LUNAR - NSCLC Clinical Trial Update: The LUNAR study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in overall survival over ...

4. optuneluahcp.com optuneluahcp.com/mpm/clinical-data/efficacy

Efficacy of Optune Lua® together with chemotherapy Patients received continuous TTFields to the thorax at a frequency of 150 kHz for at least 18 hours/day and concomitant chemotherapy every 21 days for up to 6 ...

5. horizonscandb.pcori.org horizonscandb.pcori.org/report/topics/22

Optune Lua device (NovoTTF-200T) to treat metastatic non ... Optune Lua is a portable, battery-powered, noninvasive device intended to treat NSCLC by exposing the tumor to low-intensity alternating electric fields.

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. novocure.com novocure.com/fda-grants-breakthrough-device-designation-to-the-novottf-200t-system-for-advanced-liver-cancer

FDA Grants Breakthrough Device Designation ... - Novocure The FDA granted breakthrough device designation in part based on clinical data from Novocure's phase 2 pilot HEPANOVA trial testing the safety ...