LUNAR-4: Effect of Tumor Treating Fields (TTFields) (150 kHz) Concurrent With Pembrolizumab for Treatment of Metastatic Non-small Cell Lung Cancer (NSCLC)

LUNAR-4: Pilot, Single Arm, Open-Label, Multinational Study of Tumor Treating Fields (TTFields, 150 kHz) Concomitant With Pembrolizumab for the Treatment of Metastatic Non-Small Cell Lung Cancer (NSCLC) Previously Treated With a PD-1/PD-L1 Inhibitor and Platinum-Based Chemotherapy

The purpose of the study is to test the effectiveness and safety of TTFields therapy, delivered using the NovoTTF-200T device, concomitant with pembrolizumab in subjects with metastatic NSCLC previously treated with a PD-1/PD-L1 inhibitor and platinum-based chemotherapy.

INCLUSION CRITERIA:

• ≥18 years of age
• Histologically or cytologically confirmed diagnosis of NSCLC.
• Documented positive tumor PD-L1 expression (TPS≥1%).
• Eastern Cooperative Oncology Group (ECOG) Score of 0-1.
• Diagnosis of radiological progression while on or after first platinum-based systemic therapy administered for advanced or metastatic disease.
• Subjects must have received one line of PD-1/PD-L1 inhibitor therapy for advanced or metastatic NSCLC. PD-1/PD-L1 inhibitor may have been given alone or in combination with other therapy.
• Subjects who received PD-1/PD-L1 inhibitor for advanced disease, must have had a best response on PD-1/PD-L1 inhibitor of stable disease (SD), partial response (PR) or complete response (CR).
• Subjects must have experienced disease progression more than 84 days following Cycle 1 Day 1 (C1D1) of their most recent PD-1/PD-L1 inhibitor therapy.

EXCLUSION CRITERIA - All individuals meeting any of the following exclusion criteria will be excluded from study participation:

• Mixed small cell and NSCLC histology.
• Subject must not have leptomeningeal disease or spinal cord compression.
• Subject must not have untreated, symptomatic brain metastases, or residual neurological dysfunction.
• Subjects must not have received more than one line of PD-1/PD-L1 inhibitor for advanced disease.
• Subjects with a known sensitizing mutation for which the Food and Drug Administration (FDA)-approved targeted therapy for NSCLC exists (e.g., EGFR, ALK, ROS1) are excluded unless previously received at least one of the approved therapy(ies).
• Subjects with more than 2 lines of therapy in the advanced setting.
• Pregnant or breastfeeding.
• Implantable electronic medical devices (e.g. pacemaker, defibrillator) in the upper torso.
• Known allergies to medical adhesives or hydrogel.