OncoMatch/Clinical Trials/NCT06124118
Tumor Treating Fields for Locally Advanced NSCLC
Is NCT06124118 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including NovoTTF-200T (TTFields) System and Durvalumab for non small cell lung cancer.
Treatment: NovoTTF-200T (TTFields) System · Durvalumab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Non-Small Cell Lung Carcinoma
Disease stage
Required: Stage IIIA, IIIB, IIIC
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: thoracic radiation
Prior thoracic radiation, including breast radiation
Cannot have received: systemic immunotherapy
Prior systemic immunotherapy or radiotherapy for NSCLC
Cannot have received: TTFields
Prior exposure to TTFields
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1500/mm3; Platelet count ≥ 100,000/mm3; Hemoglobin ≥ 10 g/dL (transfusions are allowed for Device Duration Level 2 only if anemia is due to prior therapy)
Kidney function
Estimated creatinine clearance ≥ 50 mL/min by Cockcroft-Gault formula
Liver function
Total Bilirubin ≤ 1.5x institutional ULN or direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN. AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN. Subjects with liver metastases will be allowed to enroll with AST and ALT levels ≤ 5 x ULN.
Cardiac function
No congestive heart failure NYHA Class III or IV, unstable angina, serious arrhythmias, stroke/TIA/MI/thromboembolic event within 3 months, QTcF > 500 ms, known congenital long QT, LVEF < 50%, uncontrolled hypertension (≥ 160/90), no implanted pacemaker/defibrillator/other electrical medical devices
Adequate organ function as defined as: Hematologic: ANC ≥ 1500/mm3, Platelet count ≥ 100,000/mm3, Hemoglobin ≥ 10 g/dL. Hepatic: Total Bilirubin ≤ 1.5x institutional ULN or direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN. AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN. Subjects with liver metastases will be allowed to enroll with AST and ALT levels ≤ 5 x ULN. Renal: Estimated creatinine clearance ≥ 50 mL/min by Cockcroft-Gault formula. Cardiac: see exclusion criteria for details.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Huntsman Cancer Institute · Salt Lake City, Utah
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06124118 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
What disease stage is eligible?
Stage IIIA or IIIB or IIIC is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages