Actively Recruiting
Tumor Treating Fields for Locally Advanced NSCLC
Led by University of Utah · Updated on 2026-01-08
30
Participants Needed
1
Research Sites
188 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this open-label, Phase 1 clinical trial is to determine the safety of TTFields started concurrently with SOC chemoradiation and during consolidation durvalumab in locally advanced, unresectable stage III non-small cell lung cancer (NSCLC). The main question it aims to answer is, "What is the rate of dose-limiting toxicities (DLTs) with TTFields in addition to concurrent chemoradiation and consolidation durvalumab?" Step 1 * All participants will be screened and enrolled in Step 1 prior to SOC concurrent chemoradiation. * The purpose of the Step 1 Registration is to ensure that eligible participants are candidate for concurrent chemoradiation and do not have contraindications to TTF therapy or immunotherapy. * Starting Level: Participants in Device Duration Level 1 will receive standard of care concurrent chemoradiation following Step 1 Registration. * Escalation Level : Participants in Device Duration Level 2 will begin standard of care chemoradiation and treatment with TTFields following Step 1 Registration. Step 2 * All participants will complete Step 2 screening and enrollment prior to receiving treatment with durvalumab consolidation therapy and TTFields. * The purpose of the Step 2 registration is to ensure that eligible patients meet criteria for consolidation durvalumab after completion of CRT and do not have contraindications to TTF. therapy or immunotherapy.
CONDITIONS
Official Title
Tumor Treating Fields for Locally Advanced NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 22 years or older with histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Clinical stage IIIA, IIIB, or IIIC NSCLC with unresectable disease
- Completion of staging scans (FDG-PET/CT and brain MRI or CT) within 60 days prior to chemoradiation
- Ability to operate the NovoTTF-200T System independently or with caregiver help
- Eligible for standard of care concurrent chemoradiation and consolidation immunotherapy
- Measurable disease by RECIST 1.1 criteria
- ECOG Performance Status 0 or 1
- Adequate hematologic, hepatic, and renal function as specified in the protocol
- Negative pregnancy test or evidence of post-menopausal status for subjects of childbearing potential
- Agreement to use effective contraception if applicable
- Ability to provide informed consent and willingness to sign consent form
- Recovery to baseline or Grade 1 or less toxicities from prior therapy before consolidation phase
- Resolution of any prior radiation pneumonitis to less than grade 1
You will not qualify if you...
- Prior thoracic radiation or prior exposure to TTFields
- Prior systemic immunotherapy or radiotherapy for NSCLC
- Known allergy to skin adhesives or hydrogel
- Hypersensitivity to radiation due to genetic or connective tissue disorders
- Use of other investigational agents
- Major surgery within 4 weeks before starting study treatment or not fully recovered
- Diagnosis of another malignancy within 2 years except certain treated cancers
- Uncontrolled significant illnesses including severe cardiovascular conditions
- Implanted pacemaker, defibrillator, or other electrical medical devices
- Known HIV infection with detectable viral load within 6 months before treatment
- Active infections including tuberculosis, hepatitis B or C with positive viral RNA
- Medical or psychiatric conditions impairing consent or compliance
- History of allogenic stem cell or solid organ transplant
- Active or prior autoimmune or inflammatory disorders, except specified exceptions
- Use of immunosuppressive medications within 14 days before treatment start except certain steroids
- History of exudative pleural effusions
- Peripheral neuropathy greater than grade 1 in patients receiving carboplatin and paclitaxel chemotherapy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
K
Kaitlin Stephens
CONTACT
M
Matthew Gumbleton, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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