A Pilot Study to Understand the Impact of Therapy With Tumour Treating Fields (TTFields) in NSCLC

NCT ID: NCT05698264

Last Updated: 2023-01-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-20
• Study Completion Date: 2028-12-31

Brief 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.

Conditions

Non Small Cell Lung Cancer; EGFR Gene Mutation; Immune Checkpoint Inhibitor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NSCLC patients with EGFR mutation

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.

Group Type: EXPERIMENTAL

concomitant TTFields treatment device to standard of care EGFR positive NSCLC treatment

Intervention Type: DEVICE

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.

NSCLC patients planned to receive PD-1 inhibitors

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.

Group Type: EXPERIMENTAL

concomitant TTFields treatment device to standard of care anti PD-1 NSCLC treatment

Intervention Type: DEVICE

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.

Interventions

concomitant TTFields treatment device to standard of care EGFR positive NSCLC treatment

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.

Intervention Type: DEVICE

concomitant TTFields treatment device to standard of care anti PD-1 NSCLC treatment

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nir Peled

OTHER

Sponsor Role: lead

Responsible Party

Nir Peled

Head of Oncology

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Shaare Zedek Medical Center

Jerusalem, , Israel

Countries

Israel

Central Contacts

Nir Peled, MD

Role: CONTACT

nirp@szmc.org.il

+972587040620

Other Identifiers

SZMC-0216-22

Identifier Type: -

Identifier Source: org_study_id