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.