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

Phase 2

Recruiting

• Conditions: Non-Small Cell Lung Cancer (NSCLC)
• Interventions: Device: NovoTTF-200T; Drug: Pembrolizumab

• Registration Number: NCT06558799
• Lead Sponsor: NovoCure GmbH

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-31
• Study First Submitted QC: 2024-08-13
• Study First Posted: 2024-08-19
• Study Start: 2024-10-14
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-02
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NovoTTF-200T + Pembrolizumab	NovoTTF-200T	-
NovoTTF-200T + Pembrolizumab	Pembrolizumab	-

Primary Outcome Measures

Name	Time	Method
Overall Survival	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)

Trial Locations

Locations (14)

Montpellier University Hospital; 🇫🇷 Montpellier, France

Clínica Universidad de Navarra, Madrid; 🇪🇸 Madrid, Spain

Clínica Universidad de Navarra; 🇪🇸 Pamplona, Spain

Universitätsklinik f. Innere Medizin III; 🇦🇹 Salzburg, Austria

Vitkovicka Nemocnice; 🇨🇿 Ostrava, Czechia

FN Motol; 🇨🇿 Praha, Czechia

Humanitas Gavazzeni Bergamo-U.O.Farmacia-Edificio D Piano -1; 🇮🇹 Bergamo, Italy

AOUS Policlinico Le Scotte U.O.C. Immunoterapia Oncologica; 🇮🇹 Siena, Italy

Rijnstate Ziekenhuis; 🇳🇱 Arnhem, Netherlands

Pratia MCM Kraków; 🇵🇱 Kraków, Poland

MS Pneumed Janusz Milanowski, Katarzyna Szmygin-Milanowska Spó?ka Jawna; 🇵🇱 Lublin, Poland

Hospital Universitario Arnau de Vilanova; 🇪🇸 Lleida, Spain

Hospital Regional Universitario de Malaga (Hospital Civil); 🇪🇸 Málaga, Spain

Hospital Universitario Virgen del Rocio; 🇪🇸 Sevilla, Spain