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

Обзор

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.

Вмешательства

• Устройство 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.
• Устройство 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.

Первичные конечные точки

• Molecular ctDNA characterization under concomitant TTFields therapy - cohort A (EGFR) [Срок оценки: 5 years]
• In vitro peripheral lymphocytes activity characterization under concomitant TTFields therapy - cohort B (under PD-1 inhibitors treatment) [Срок оценки: 5 years]
• Characterization of the impact of TTFields on peripheral lymphocytes proliferation ex-vivo - cohort B (PD-1 inhibitors treatment) [Срок оценки: 5 years]

Вторичные конечные точки (3)

• Safety will be assessed by recording adverse events in both cohorts. [Срок оценки: 5 years]
• Objective response rate [Срок оценки: 5 years]
• DoR [Срок оценки: 5 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Израиль · 1 центр

• Shaare Zedek Medical Center — Jerusalem

Идентификаторы

NCT: NCT05698264 · SZMC-0216-22

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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