TTFields for Lung Cancer

Recruiting in Palo Alto (17 mi)

+6 other locations

Overseen by Prasad Adusumilli, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Active malignancy, Cardiac arrhythmias, Pacemaker, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment NovoTTF-200T System for lung cancer?

The research suggests that Tumor Treating Fields (TTFields) therapy, which is part of the NovoTTF-200T System, can enhance the effectiveness of standard cancer treatments like taxanes without adding significant side effects. This therapy uses electric fields to target cancer cells, potentially improving outcomes for patients with certain cancers, including lung cancer. ^{1 2 3 4 5}

How does the TTFields treatment for lung cancer differ from other treatments?

TTFields (Tumor Treating Fields) is unique because it uses electric fields to disrupt cancer cell division, unlike traditional treatments like chemotherapy or radiotherapy that use drugs or radiation. This non-invasive approach targets cancer cells specifically, potentially reducing side effects compared to conventional therapies. ^{3 6 7 8 9}

Research Team

Prasad Adusumilli, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• NovoTTF-200T System (Device)

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.

Participant Groups

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+

Lisa M. DeAngelis

Memorial Sloan Kettering Cancer Center

Chief Medical Officer since 2021

MD from Columbia University

Selwyn M. Vickers

Memorial Sloan Kettering Cancer Center

Chief Executive Officer since 2022

MD from Johns Hopkins University

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

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

19F MRI in orthotopic cancer model via intratracheal administration of ανβ3-targeted perfluorocarbon nanoparticles. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

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

4. Germany pubmed.ncbi.nlm.nih.gov

Phase II study of fotemustine in untreated inoperable non-small-cell lung cancer. [2019]

5. Ireland pubmed.ncbi.nlm.nih.gov

Phase I-II and pharmacokinetic study of a new fotemustine schedule in advanced non-small cell lung cancer. [2019]

6. France pubmed.ncbi.nlm.nih.gov

[Radiotherapy for non-small cell lung cancer]. [2009]

7. United States 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. [2018]

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

Targeted therapy for lung cancer. [2018]

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

18F-FLT uptake kinetics in head and neck squamous cell carcinoma: a PET imaging study. [2022]