LUNAR-4: Effect of Tumor Treating Fields (TTFields) (150 kHz) Concurrent With Pembrolizumab for Treatment of Metastatic Non-small Cell Lung Cancer (NSCLC)
- Conditions
- Non-Small Cell Lung Cancer (NSCLC)
- Registration Number
- NCT06558799
- Lead Sponsor
- NovoCure GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 69
INCLUSION CRITERIA:<br><br> - =18 years of age<br><br> - Histologically or cytologically confirmed diagnosis of NSCLC.<br><br> - Documented positive tumor PD-L1 expression (TPS=1%).<br><br> - Eastern Cooperative Oncology Group (ECOG) Score of 0-1.<br><br> - Diagnosis of radiological progression while on or after first platinum-based<br> systemic therapy administered for advanced or metastatic disease.<br><br> - Subjects must have received one line of PD-1/PD-L1 inhibitor therapy for advanced or<br> metastatic NSCLC. PD-1/PD-L1 inhibitor may have been given alone or in combination<br> with other therapy.<br><br> - Subjects who received PD-1/PD-L1 inhibitor for advanced disease, must have had a<br> best response on PD-1/PD-L1 inhibitor of stable disease (SD), partial response (PR)<br> or complete response (CR).<br><br> - Subjects must have experienced disease progression more than 84 days following Cycle<br> 1 Day 1 (C1D1) of their most recent PD-1/PD-L1 inhibitor therapy.<br><br>EXCLUSION CRITERIA - All individuals meeting any of the following exclusion criteria will<br>be excluded from study participation:<br><br> - Mixed small cell and NSCLC histology.<br><br> - Subject must not have leptomeningeal disease or spinal cord compression.<br><br> - Subject must not have untreated, symptomatic brain metastases, or residual<br> neurological dysfunction.<br><br> - Subjects must not have received more than one line of PD-1/PD-L1 inhibitor for<br> advanced disease.<br><br> - Subjects with a known sensitizing mutation for which the Food and Drug<br> Administration (FDA)-approved targeted therapy for NSCLC exists (e.g., EGFR, ALK,<br> ROS1) are excluded unless previously received at least one of the approved<br> therapy(ies).<br><br> - Subjects with more than 2 lines of therapy in the advanced setting.<br><br> - Pregnant or breastfeeding.<br><br> - Implantable electronic medical devices (e.g. pacemaker, defibrillator) in the upper<br> torso.<br><br> - Known allergies to medical adhesives or hydrogel.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Survival
- Secondary Outcome Measures
Name Time Method