Tumor Treating Fields for Locally Advanced NSCLC - Trial NCT06124118

Timeline & Enrollment

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