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
Status: Recruiting
Location: See all (21) locations...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• ≥18 years of age
• Histologically or cytologically confirmed diagnosis of NSCLC.
• 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.
Locations
Other Locations
Austria
Universitätsklinik f. Innere Medizin III
RECRUITING
Salzburg
France
APHP - Hôpital Ambroise-Paré
RECRUITING
Boulogne-billancourt
Centre hospitalier intercommunal de Créteil Service de Pneumologie
RECRUITING
Créteil
Centre Léon Berard Service D'oncologie Médicale
RECRUITING
Lyon
Hôpital Européen Marseille
RECRUITING
Marseille
Montpellier University Hospital
RECRUITING
Montpellier
Hôpital Privé du Confluent Service D'oncologie Médicale
RECRUITING
Nantes
Centre Hospitalier Intercommunal de Cornouaille Service D'oncologie Médicale
RECRUITING
Quimper
Italy
Humanitas Gavazzeni Bergamo-U.O.Farmacia-Edificio D Piano -1
RECRUITING
Bergamo
Istituto Europeo di Oncologia
RECRUITING
Milan
AO SM Misericordia di Perugia
RECRUITING
Perugia
AOUS Policlinico Le Scotte U.O.C. Immunoterapia Oncologica
RECRUITING
Siena
Netherlands
Rijnstate Ziekenhuis
RECRUITING
Arnhem
Poland
Pratia MCM Kraków
RECRUITING
Krakow
MS Pneumed Janusz Milanowski, Katarzyna Szmygin-Milanowska Spó?ka Jawna
RECRUITING
Lublin
Spain
Hospital Universitario del Vinalopó
RECRUITING
Elche
Hospital Universitario Arnau de Vilanova
RECRUITING
Lleida
Clínica Universidad de Navarra, Madrid
RECRUITING
Madrid
Hospital Regional Universitario de Malaga (Hospital Civil)