OncoMatch/Clinical Trials/NCT06124118
Tumor Treating Fields for Locally Advanced NSCLC
Is NCT06124118 recruiting? Yes, currently enrolling (May 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
Cancer type
Small Cell Lung Cancer
Disease stage
Required: Stage IIIA, IIIB, IIIC
Performance status
ECOG 0–1(Restricted strenuous activity)
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
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