An official website of the United States government
A Study of Tumor-Treating Fields (TTFields) in People with Lung Adenocarcinoma
Trial Status: active
This phase I trial tests the safety and feasibility of a tumor-treating fields (TTFields) treatment device (NovoTTF-200T System) for the treatment of patients with stage IA2, IA3 or IB lung adenocarcinoma that is able to be removed by surgery (resectable). TTFields therapy is a type of electromagnetic field therapy. The NovoTTF-200T System is a portable device that is worn on the chest and delivers low-intensity, alternating electric fields through patches that are worn on the skin. This may disrupt the ability of tumor cells to divide and grow.
Inclusion Criteria
The participant (or legally acceptable representative [LAR], if applicable) provides written informed consent for the study
The participant is ≥ 22 years of age on the day of signing informed consent
The participant has clinical stage IA2, IA3 or IB biopsy-proven lung ADC and is eligible for anatomical resection
The participant has a lung nodule > 1 cm and suspected lung ADC with a plan to undergo biopsy
The participant with multiple nodules has one nodule that meets the criteria
The participant has no history of prior malignancy in the chest or has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy
Exclusion Criteria
Patients receiving therapy for concurrent active malignancy
Patients with a history of cardiac arrhythmias and/or pacemaker use
Patients with lung nodules ≤ 1cm
Patients with lung nodules that are pure ground glass opacities (GGOs) of any size
Patients with lung nodules that are < 50% solid of any size
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05764954.
I. To assess the safety and feasibility of TTFields (NovoTTF-200T System) treatment for patients prior to the resection of stage IA3 or IB resectable lung adenocarcinoma (ADC).
SECONDARY OBJECTIVES:
I. To investigate immune response in resected tumor, peritumoral lung, and lymph nodes in patients following TTFields treatment.
II. To investigate associated T-cell clonal responses in peripheral blood in TTFields-treated patients compared to controls.
EXPLORATORY OBJECTIVES:
I. To investigate histopathological changes in resected tumor and peritumoral lung.
II. To assess the changes in immune microenvironment in tumors in relation to the predominant histological subtype.
III. To characterize chemokine receptor expression on tumor-infiltrating and peripheral blood T cells following TTFields application.
IV. To investigate relative accumulation of effector (CD3+, CD20+, M1 macrophages) and suppressor (T regulatory cells, CD63/162+ M2 macrophages) immune cell infiltration in lung ADC tumors treated with TTFields compared to controls.
V. To evaluate and quantify T-cell receptor beta responses in the tumor and peripheral blood.
OUTLINE:
Patients undergo TTFields treatment with the NovoTTF-200T System for an average of 18 hours per day for 3 weeks. Patients then undergo resection surgery. Patients undergo blood sample collection throughout the study and may undergo tissue sample collection at the time of standard of care diagnostic procedures and/or surgery.
After completion of surgery, patients are followed up at 1-2 weeks, 3 months and 6 months.
Trial PhasePhase I
Trial Typetreatment
Lead OrganizationMemorial Sloan Kettering Cancer Center
