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

NovoCure

Status and phase

Enrolling

Phase 2

Conditions

Non-Small Cell Lung Cancer (NSCLC)

Treatments

Drug: Pembrolizumab

Device: NovoTTF-200T

Study type

Interventional

Funder types

Industry

Identifiers

NCT06558799

EF-50

Details and patient eligibility

About

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.

Enrollment

69 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.