NCT05698264Not yet recruiting
A Pilot Study to Understand the Impact of Therapy With Tumour Treating Fields (TTFields) in NSCLC
Source: ClinicalTrials.gov · Last updated 26 Jan 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Low intensity, intermediate frequency (100-300 kHz) alternating electric fields, also known as Tumor Treating Fields (TTFields) were found to have a profound inhibitory effect on the growth rate of a variety of human cancer cells. Previous study showed anti-tumor activity in respect of melanoma, glioblastoma (GBM), breast carcinoma and NSCLC cell lines. This study aims to assess the impact of TTFields on NSCLC though the understanding of tumor evolution and peripheral lymphocytes activity and proliferation. Concomitant to drug therapy, patients will receive treatment with Tumor Treating Fields (TTFields), generated by the medical device NovoTTF-200T with a recommended duration of minimum 18 h a day. TTFields administered using insulated transducer arrays applied to the skin surrounding the region of a malignant tumor. 50 patients will be recruited according to the study design in two cohorts and will receive TTFields therapy: Cohort A: Adult NSCLC EGFR positive mutation. Cohort B: Adult NSCLC patients to be treated with PD-1 inhibitors. The cohort A will focus on the clonal evolution in EGFR mutated lung cancer patients by using circulating tumor DNA (ctDNA) analysis of paired baseline and end-of-treatment (EOT) plasma samples. The cohort B will study the impact of TTField on the profile, activity, and proliferation of peripheral lymphocytes. Lymphocytes will be purified from whole blood samples for the profile, proliferation, and activity analyzed by FACS. Treatment with TTFields will be administered until progressive disease, unacceptable toxicity1, withdrawal of consent or death. After the end of treatment, the patients will be followed until data cutoff date or 2 years after the last patient had entered the study.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 23 Nov 2022
- Start date
- 20 Jan 2023
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Nir Peled
- Diseases
- Lung cancer
- NCT number
- NCT05698264
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 20 Jan 2023 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Have been diagnosed with another primary malignancy within the past 3 years (except for adequately treated non-melanoma skin cancer, cervical cancer in situ or prostate cancer, which are allowed within 3 years).
- Have any condition or illness that, in the opinion of the investigator, would compromise participants' safety or interfere with the evaluation.
Other
- Implanted electronic devices (e.g. pacemaker) in the upper torso.
- Be pregnant or breastfeeding.
Who the study is looking for
- Male and female patients 18 years of age and older.
- Have histologically or cytologically confirmed lung cancer.
- Documented next generation sequencing assay performed on tumor sample in Clinical Laboratory Improvement Amendments (CLIA)-approved laboratory.
- Have at least 1 measurable lesion per RECIST v1.1
- Have life expectancy ≥3 months.
- Have Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- Must provide a signed and dated informed consent indicating that the participants have been informed of all pertinent aspects of the study, including the potential risks, and is willingly participating.
- Have the willingness and ability to comply with scheduled visits and study procedures.
- Cohort A, confirmed EGFR mutation.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shaare Zedek Medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.