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NCT06124118Suspended

Tumor Treating Fields for Locally Advanced NSCLC

A Feasibility Study to Evaluate the Addition of Tumor Treating Fields to Treatment of Locally Advanced Stage III NSCLC
University of UtahPhase 1ClinicalTrials.govradiation
Study focus
Drug/Device/Intervention
carboplatin chemotherapy
Study type
Interventional
Intervention type
radiation
Sponsor & location
Primary sponsor
University of Utah
Location
Salt Lake City, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Nov 03, 2023
End date
Nov 15, 2026
Enrollment
30 participants
Primary outcome

Rate of dose-limiting toxicities (DLTs) during the DLT evaluation period

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
 
 - 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.

ICD-10 classifications
Secondary malignant neoplasm of lungMalignant neoplasm: Lower lobe, bronchus or lungMalignant neoplasm: Middle lobe, bronchus or lungMalignant neoplasm: Bronchus or lung, unspecifiedMalignant neoplasm of bronchus and lung
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06124118
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06124118 through Pure Global AI's free database. This Phase 1 trial is sponsored by University of Utah and is currently Suspended. The study focuses on Non Small Cell Lung Cancer. Target enrollment is 30 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.