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

May 28, 2026 updated by: NovoCure GmbH

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Salzburg, Austria
        • Universitätsklinik f. Innere Medizin III
  • Czechia
      • Ostrava, Czechia, 1192
        • Vitkovicka Nemocnice
      • Prague, Czechia, 128 08
        • General University Hospital in Prague, Clinic of Oncology
      • Prague, Czechia, 150 06
        • FN Motol
  • France
      • Boulogne-Billancourt, France, 92100
        • APHP - Hôpital Ambroise-Paré
      • Créteil, France, 94010
        • Centre hospitalier intercommunal de Créteil Service de Pneumologie
      • Lyon, France, 69373
        • Centre Léon Berard Service D'oncologie Médicale
      • Marseille, France, 13003
        • Hôpital Européen Marseille
      • Montpellier, France, 34295
        • Montpellier University Hospital
      • Nantes, France, 44277
        • Hôpital Privé du Confluent Service D'oncologie Médicale
      • Quimper, France, 29107
        • Centre Hospitalier Intercommunal de Cornouaille Service D'oncologie Médicale
  • Italy
      • Bergamo, Italy
        • Humanitas Gavazzeni Bergamo-U.O.Farmacia-Edificio D Piano -1
      • Milan, Italy, 20141
        • Istituto Europeo Di Oncologia
      • Perugia, Italy, 06129
        • AO SM Misericordia di Perugia
      • Siena, Italy, 53100
        • AOUS Policlinico Le Scotte U.O.C. Immunoterapia Oncologica
  • Netherlands
      • Arnhem, Netherlands
        • Rijnstate Ziekenhuis
  • Poland
      • Krakow, Poland
        • PRATIA MCM Kraków
      • Lublin, Poland
        • MS Pneumed Janusz Milanowski, Katarzyna Szmygin-Milanowska Spó?ka Jawna
  • Spain
      • Elche, Spain, 03293
        • Hospital Universitario del Vinalopó
      • Lleida, Spain
        • Hospital Universitario Arnau de Vilanova
      • Madrid, Spain, 28027
        • Clínica Universidad de Navarra, Madrid
      • Málaga, Spain
        • Hospital Regional Universitario de Malaga (Hospital Civil)
      • Pamplona, Spain, 31008
        • Clinica Universidad de Navarra
      • Seville, Spain
        • Hospital Universitario Virgen del Rocio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NovoTTF-200T + Pembrolizumab
Drug: Pembrolizumab
Pembrolizumab is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells.
Device: NovoTTF-200T
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 16
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NovoCure GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2024

Primary Completion (Actual)

February 23, 2026

Study Completion (Actual)

February 23, 2026

Study Registration Dates

First Submitted

July 31, 2024

First Submitted That Met QC Criteria

August 13, 2024

First Posted (Actual)

August 19, 2024

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EF-50

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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