Clinical trial NCT06558799: LUNAR-4: Effect of Tumor Treating Fields (TTFields) (150 kHz) Concurrent With Pembrolizumab for Treatment of Metastatic Non-small Cell Lung Cancer (NSCLC)
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer (NSCLC)
Keywords: NSCLC
Metastatic
Lead sponsor: NovoCure Ltd.
Sponsor class: INDUSTRY
First posted: 2024-08-19
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 previously treated with a PD-1/PD-L1 inhibitor and platinum-based chemotherapy.


Eligibility 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.

Primary outcomes:
measure: Overall Survival
timeFrame: 16
Secondary outcomes:
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: Universitätsklinik f. Innere Medizin III
city: Ostrava
country: Czechia
facility: Vitkovicka Nemocnice
city: Praha
country: Czechia
facility: FN Motol
city: Créteil
country: France
facility: Centre hospitalier intercommunal de Créteil Service de Pneumologie
city: Lyon
country: France
facility: Centre Léon Berard Service D'oncologie Médicale
city: Montpellier
country: France
facility: Montpellier University Hospital
city: Nantes
country: France
facility: Hôpital Privé du Confluent Service D'oncologie Médicale
city: Quimper
country: France
facility: Centre Hospitalier Intercommunal de Cornouaille Service D'oncologie Médicale
city: Bergamo
country: Italy
facility: Humanitas Gavazzeni Bergamo-U.O.Farmacia-Edificio D Piano -1
city: Milan
country: Italy
facility: Istituto Europeo di Oncologia
city: Siena
country: Italy
facility: AOUS Policlinico Le Scotte U.O.C. Immunoterapia Oncologica
city: Arnhem
country: Netherlands
facility: Rijnstate Ziekenhuis
city: Kraków
country: Poland
facility: Pratia MCM Kraków
city: Lublin
country: Poland
facility: MS Pneumed Janusz Milanowski, Katarzyna Szmygin-Milanowska Spó?ka Jawna
city: Lleida
country: Spain
facility: Hospital Universitario Arnau de Vilanova
city: Madrid
country: Spain
facility: Clínica Universidad de Navarra, Madrid
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Malaga (Hospital Civil)
city: Pamplona
country: Spain
facility: Clínica Universidad de Navarra
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
Study officials:
References: