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: 2025-07
• Last Update Submitted: 2025-07-08
• Last Update Posted: 2025-07-09
• Primary Completion: 2026-12
• Study Completion: 2026-12-01

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 (24)

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

Vitkovicka Nemocnice; 🇨🇿 Ostrava, Czechia

General University Hospital in Prague, Clinic of Oncology; 🇨🇿 Prague, Czechia

FN Motol; 🇨🇿 Praha, Czechia

APHP - Hôpital Ambroise-Paré; 🇫🇷 Boulogne-Billancourt, France

Centre hospitalier intercommunal de Créteil Service de Pneumologie; 🇫🇷 Créteil, France

Centre Léon Berard Service D'oncologie Médicale; 🇫🇷 Lyon, France

Hôpital Européen Marseille; 🇫🇷 Marseille, France

Montpellier University Hospital; 🇫🇷 Montpellier, France

Hôpital Privé du Confluent Service D'oncologie Médicale; 🇫🇷 Nantes, France

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