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

NCT06558799 | Active Not Recruiting Phase 2 FDA Device

• 1 other identifier: EF-50
• Study Type: interventional
• Target: 69
• Locations: 7 countries
• Sites: 24

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.

Conditions

Non-Small Cell Lung Cancer (NSCLC)

Keywords

NSCLC; Metastatic

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  To compare OS in subjects treated with TTFields concomitant with pembrolizumab compared to OS of subjects who were treated with docetaxel alone in the LUNAR/ EF-24 study (superiority analysis)

  16

Study Arms (1)

NovoTTF-200T + Pembrolizumab

EXPERIMENTAL

Device: NovoTTF-200T; Drug: Pembrolizumab

Interventions

NovoTTF-200T DEVICE

The NovoTTF-200T is a portable, battery operated system intended for continuous home use, which delivers TTFields at a frequency of 150kHz to the subject by means of insulated transducer arrays. TTFields exert electric forces intended to disrupt cancer cell division and induce immunogenic cell death.

NovoTTF-200T + Pembrolizumab

Pembrolizumab DRUG

Pembrolizumab is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells.

NovoTTF-200T + Pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NovoCure GmbH: lead

Study Sites (24)

Universitätsklinik f. Innere Medizin III

Salzburg, Austria

Location

Vitkovicka Nemocnice

Ostrava, 1192, Czechia

Location

General University Hospital in Prague, Clinic of Oncology

Prague, 128 08, Czechia

Location

FN Motol

Prague, 150 06, Czechia

Location

APHP - Hôpital Ambroise-Paré

Boulogne-Billancourt, 92100, France

Location

Centre hospitalier intercommunal de Créteil Service de Pneumologie

Créteil, 94010, France

Location

Centre Léon Berard Service D'oncologie Médicale

Lyon, 69373, France

Location

Hôpital Européen Marseille

Marseille, 13003, France

Location

Montpellier University Hospital

Montpellier, 34295, France

Location

Hôpital Privé du Confluent Service D'oncologie Médicale

Nantes, 44277, France

Location

Centre Hospitalier Intercommunal de Cornouaille Service D'oncologie Médicale

Quimper, 29107, France

Location

Humanitas Gavazzeni Bergamo-U.O.Farmacia-Edificio D Piano -1

Bergamo, Italy

Location

Istituto Europeo di Oncologia

Milan, 20141, Italy

Location

AO SM Misericordia di Perugia

Perugia, 06129, Italy

Location

AOUS Policlinico Le Scotte U.O.C. Immunoterapia Oncologica

Siena, 53100, Italy

Location

Rijnstate Ziekenhuis

Arnhem, Netherlands

Location

Pratia MCM Kraków

Krakow, Poland

Location

MS Pneumed Janusz Milanowski, Katarzyna Szmygin-Milanowska Spó?ka Jawna

Lublin, Poland

Location

Hospital Universitario del Vinalopó

Elche, 03293, Spain

Location

Hospital Universitario Arnau de Vilanova

Lleida, Spain

Location

Clínica Universidad de Navarra, Madrid

Madrid, 28027, Spain

Location

Hospital Regional Universitario de Malaga (Hospital Civil)

Málaga, Spain

Location

Clínica Universidad de Navarra

Pamplona, 31008, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, Spain

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 19, 2024
• Study Start: October 14, 2024
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: October 28, 2025

Record last verified: 2025-10

Locations

CZ (3); PL (2); FR (7); NL (1); ES (6); IT (4); AU (1)