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Trial Title:
A Pilot Study to Understand the Impact of Therapy With Tumour Treating Fields (TTFields) in NSCLC
NCT ID:
NCT05698264
Condition:
Non Small Cell Lung Cancer
EGFR Gene Mutation
Immune Checkpoint Inhibitor
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
TTFields
immune checkpoint inhibitor
Non Small Cell Lung Cancer
NSCLC
EGFR Gene Mutation
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
concomitant TTFields treatment device to standard of care EGFR positive NSCLC treatment
Description:
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.
Arm group label:
NSCLC patients with EGFR mutation
Intervention type:
Device
Intervention name:
concomitant TTFields treatment device to standard of care anti PD-1 NSCLC treatment
Description:
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.
Arm group label:
NSCLC patients planned to receive PD-1 inhibitors
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. 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Male and female patients 18 years of age and older.
2. Have histologically or cytologically confirmed lung cancer.
3. Documented next generation sequencing assay performed on tumor sample in Clinical
Laboratory Improvement Amendments (CLIA)-approved laboratory.
4. Have at least 1 measurable lesion per RECIST v1.1
5. Have life expectancy ≥3 months.
6. Have Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
7. 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.
8. Have the willingness and ability to comply with scheduled visits and study
procedures.
9. Cohort A, confirmed EGFR mutation.
Exclusion Criteria:
1. Implanted electronic devices (e.g. pacemaker) in the upper torso.
2. 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).
3. Have any condition or illness that, in the opinion of the investigator, would
compromise participants' safety or interfere with the evaluation.
4. Be pregnant or breastfeeding.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Shaare Zedek Medical Center
Address:
City:
Jerusalem
Country:
Israel
Start date:
January 20, 2023
Completion date:
December 31, 2028
Lead sponsor:
Agency:
Nir Peled
Agency class:
Other
Source:
Shaare Zedek Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05698264
