Non Small Cell Lung CancerNCT05698264
A Pilot Study to Understand the Impact of Therapy With Tumour Treating Fields (TTFields) in NSCLC
A study of Non Small Cell Lung Cancer and EGFR Gene Mutation, run by Nir Peled at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, EGFR Gene Mutation, Immune Checkpoint Inhibitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 20 Jan 2023to 31 Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- Implanted electronic devices (e.g. pacemaker) in the upper torso.
- 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.
- Be pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
- Being tested
- concomitant TTFields treatment device to standard of care EGFR positive NSCLC treatment, concomitant TTFields treatment device to standard of care anti PD-1 NSCLC treatment
- Keywords
- TTFields, immune checkpoint inhibitor, Non Small Cell Lung Cancer, NSCLC, EGFR Gene Mutation
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
concomitant TTFields treatment device to standard of care EGFR positive NSCLC treatmentDevice
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.
concomitant TTFields treatment device to standard of care anti PD-1 NSCLC treatmentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| NSCLC patients with EGFR mutation | Experimental | 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. This cohort will be compared to matched EGFR patients previously analyzed by our group.
Analysis of paired samples from this study will allow a dissection of events acquired through therapy, specifically which component of the combination therapy may be driving selection of the mutations in comparison with the control group without TTFields. Receives: Device: concomitant TTFields treatment device to standard of care EGFR positive NSCLC treatment |
| NSCLC patients planned to receive PD-1 inhibitors | Experimental | The cohort B will study the impact of TTField on the profile, activity, and proliferation of peripheral lymphocytes in NSCLC patients receiving PD-1 inhibitors concomitant to TTFields treatment. Lymphocytes will be purified from whole blood samples for the profile, proliferation, and activity analyzed by FACS. Receives: Device: concomitant TTFields treatment device to standard of care anti PD-1 NSCLC treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular ctDNA characterization under concomitant TTFields therapy - cohort A (EGFR)
The primary outcome measure will be the rate of new somatic mutation detection in circulating tumor DNA (ctDNA) using Next Generation Sequencing (NGS) in patients receiving concurrent TTFields therapy. The measure will be reported as the percentage of patients showing new somatic mutations upon progression of their disease following TTFields treatment.
Measured: 5 years
In vitro peripheral lymphocytes activity characterization under concomitant TTFields therapy - cohort B (under PD-1 inhibitors treatment)
The primary outcome measure will be the evaluation of the impact of combining PD-1 inhibitors with TTFields therapy on peripheral lymphocyte activity using an in vitro assay. Whole blood samples will be collected and the assay will involve the isolation, activation, and labeling of peripheral lymphocytes from patients in cohort B with a panel of antibodies. The analysis will be performed using flow cytometry (FACS) and the longitudinal changes in peripheral lymphocyte activity will be correlated with each patient's response.
Measured: 5 years
Characterization of the impact of TTFields on peripheral lymphocytes proliferation ex-vivo - cohort B (PD-1 inhibitors treatment)
The primary outcome measure will be the quantification of peripheral lymphocyte proliferation in patients receiving PD-1 inhibitors therapy using an in vitro assay. Whole blood samples will be collected and the assay will involve the isolation, labeling, and analysis of peripheral lymphocytes with carboxyfluorescein diacetate succinimidyl ester (CFSE). Proliferation will be measured using flow cytometry (FACS) and the longitudinal changes in peripheral lymphocyte proliferation will be correlated with each patient's response to the therapy in cohort B.
Measured: 5 years
Secondary outcomes (3)
Safety will be assessed by recording adverse events in both cohorts.
Grading of an Adverse Event. The descriptions and grading scales found in the revised NCI Common Toxicity Criteria (CTC) version 4.0 will be utilized for assessing severity of adverse events. If the toxicity is not characterized adequately by the NCI toxicity scale, the investigator will use the adjectives MILD, MODERATE, SEVERE to describe the maximum intensity of the adverse event.
Measured: 5 years
Objective response rate
Objective response rate (ORR) assessed by the investigator, defined as the proportion of the participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid tumors (RECIST) v1.1, after initiation of study treatment.
Measured: 5 years
DoR
Duration of response, defined as the time interval from the time that the measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that the progressive disease is objectively documented or death. Patients without progressive disease or death will be censored at the last valid response assessment
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start20 Jan 2023 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nir Peled
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nir Peled, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05698264
- Sponsor's protocol ID
- SZMC-0216-22
- Status last verified
- Jan 2023
- First submitted
- 23 Nov 2022
- Last updated
- 26 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No