A Feasibility Study to Evaluate the Addition of Tumor Treating Fields to Treatment of Locally Advanced Stage III NSCLC
Overview
- Phase
- Phase 1
- Intervention
- NovoTTF-200T (TTFields) System
- Conditions
- Non Small Cell Lung Cancer
- Sponsor
- University of Utah
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Rate of dose-limiting toxicities (DLTs) during the DLT evaluation period
- Status
- Recruiting
- Last Updated
- 3 months ago
Overview
Brief Summary
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
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All participants will be screened and enrolled in Step 1 prior to SOC concurrent chemoradiation.
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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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Step 1: Pre-Chemoradiation Inclusion Criteria
- •Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC).
- •Clinical AJCC (AJCC, 8th ed.) stage IIIA or IIIB, or IIIC NSCLC with unresectable disease. Staging FDG-PET/CT and MRI brain (preferred) or CT head with contrast scan must have been completed within 60 days prior to initiation of concurrent CRT. Unresectable disease must be determined by a multi-disciplinary team unless, in the opinion of the treating investigator, the subject's disease is clearly unresectable. Subjects who refuse surgery will be considered to have unresectable disease.
- •Able to operate the NovoTTF-200T System independently or with the help of a caregiver.
- •Eligible to receive standard of care chemoradiation per institutional standards.
- •Subject must have measurable disease by RECIST 1.1 criteria by CT.
- •ECOG Performance Status ≤
- •Adequate organ function as defined as:
- •Hematologic:
- •Absolute neutrophil count (ANC) ≥ 1500/mm3
Exclusion Criteria
- •Step 1: Pre-Chemoradiation Phase Exclusion Criteria
- •Prior thoracic radiation, including breatbreast radiation.
- •Prior exposure to TTFields.
- •Prior systemic immunotherapy or radiotherapy for NSCLC.
- •nown underlying skin hypersensitivity or known allergy to skin adhesives or hydrogel.
- •Known hypersensitivity to radiation due to genetic susceptibility, connective tissue disease, or any other cause.
- •Receiving other investigational agents.
- •Major surgery (per treating investigator) within 4 weeks prior to starting study drug or who have not fully recovered from major surgery. Note: Biopsies without significant complications will not be considered major surgery.
- •The diagnosis of another malignancy within ≤ 2 years before study enrollment, except for those considered to be adequately treated with no evidence of disease or symptoms and/or will not require therapy during the study duration (i.e., basal cell or squamous cell skin cancer, carcinoma in situ of the breast, bladder or of the cervix, or low-grade prostate cancer with Gleason Score ≤ 6).
- •Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions:
Arms & Interventions
Device Duration Level 1
Participants in Device Duration Level 1 will receive Tumor Treatment Fields (TTF) therapy during standard of care consolidation durvalumab.
Intervention: NovoTTF-200T (TTFields) System
Device Duration Level 1
Participants in Device Duration Level 1 will receive Tumor Treatment Fields (TTF) therapy during standard of care consolidation durvalumab.
Intervention: Durvalumab
Device Duration Level 2
Participants in in Device Duration Level 2 will begin TTF therapy during SOC durvalumab and SOC Concurrent chemoradiation following Device Duration Level 1.
Intervention: carboplatin chemotherapy
Device Duration Level 2
Participants in in Device Duration Level 2 will begin TTF therapy during SOC durvalumab and SOC Concurrent chemoradiation following Device Duration Level 1.
Intervention: NovoTTF-200T (TTFields) System
Device Duration Level 2
Participants in in Device Duration Level 2 will begin TTF therapy during SOC durvalumab and SOC Concurrent chemoradiation following Device Duration Level 1.
Intervention: Durvalumab
Outcomes
Primary Outcomes
Rate of dose-limiting toxicities (DLTs) during the DLT evaluation period
Time Frame: 12 weeks
To assess the safety of Tumor Treating Fields (TTFields) started concurrently with SOC chemoradiation and during consolidation durvalumab for treatment of unresectable stage III non-small cell lung cancer (NSCLC).
Secondary Outcomes
- Overall survival (OS) as defined as the time from CRT until death from any cause.(1 year 6 months)
- The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE, version 5.0), seriousness, duration, and relationship to study treatment(1 year 6 months)
- Progression-free survival as defined as the time from CRT to the time documented disease progression (as assessed by RECIST 1.1) or death from any cause.(1 year 6 months)