Status:
ACTIVE_NOT_RECRUITING
LUNAR-4: Effect of Tumor Treating Fields (TTFields) (150 kHz) Concurrent With Pembrolizumab for Treatment of Metastatic Non-small Cell Lung Cancer (NSCLC)
Lead Sponsor:
NovoCure GmbH
Conditions:
Non-Small Cell Lung Cancer (NSCLC)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 previous...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT06558799
Start Date
October 14 2024
End Date
January 31 2026
Last Update
October 28 2025
Active Locations (24)
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1
Universitätsklinik f. Innere Medizin III
Salzburg, Austria
2
Vitkovicka Nemocnice
Ostrava, Czechia, 1192
3
General University Hospital in Prague, Clinic of Oncology
Prague, Czechia, 128 08
4
FN Motol
Prague, Czechia, 150 06