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NCT06124118 · ClinicalTrials.gov record · last posted 2026-08-03

Tumor Treating Fields for Locally Advanced NSCLC

Study acronym: NOVOCURE
StatusWithdrawn
PhasePhase 1
Started2024-04-04
View on ClinicalTrials.gov ↗
Why the trial stopped
Slow accrual
from the ClinicalTrials.gov record
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.

Protocol amendment history 3 changes detected by DataLookout

2026-08-04
critical
Trial status changed: Recruiting → Withdrawn
2026-08-04
critical
Trial withdrawn: Slow accrual
2026-08-04
critical
Enrollment reduced: 30 → 0 participants
Trial Details
NCT Number NCT06124118
Lead Sponsor University of Utah
Conditions Non Small Cell Lung Cancer
Start Date 2024-04-04
Primary Completion 2026-11-15 (estimated)
Study Completion 2027-11-15 (estimated)
Updated on ClinicalTrials.gov 2026-08-03