LUNAR-2: TTFields With Pembrolizumab + Platinum-based Chemotherapy for Metastatic NSCLC
Start Date
7/31/2024
Completion Date
10/1/2028
Summary
This study, known as LUNAR-2, aims to investigate the effectiveness and safety of using TTFields, delivered by the NovoTTF-200T device, concomitantly administered with pembrolizumab and platinum-based chemotherapy for patients with advanced non-small cell lung cancer that has spread to other parts of the body. The primary goals of the study are to assess overall survival and progression-free survival. Secondary objectives include analyzing outcomes based on the specific histology (subtype) of the lung cancer.
Detailed Description
LUNAR-2 is a pivotal, randomized, open-label study that aims to evaluate the effectiveness and safety of Tumor Treating Fields (TTFields) concomitantly administered with pembrolizumab and platinum-based chemotherapy for the treatment of metastatic non-small cell lung cancer (NSCLC). The primary objectives of the study are to assess overall survival (OS) and progression-free survival (PFS) in subjects treated with TTFields, pembrolizumab, and platinum-based chemotherapy compared to those treated with pembrolizumab and platinum-based chemotherapy alone. PFS will be evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The secondary endpoints of this study will evaluate PFS and OS, stratified by the specific histological subtype of NSCLC and PD-L1 Tumor Proportion Score (TPS). The population will consist of subjects with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 and will be stratified as follow: 1. Histology - Squamous vs. non-squamous 2. PD-L1 expression level - TPS \<1% vs. 1% ≤TPS \<50% vs. TPS ≥50% 3. Prior treatment with immunotherapy - yes vs. no The study will be conducted globally at approximately 130 participating sites. The study device, NovoTTF-200T, is a portable, battery-operated system that delivers TTFields at a frequency of 150kHz. It utilizes insulated transducer arrays to deliver electric forces intended to disrupt cancer cell division.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
NovoTTF-200T
Pembrolizumab
Platinum based chemotherapy
Conditions
Locations
Central Alabama Research
Birmingham, Alabama 35209
United States
Western Regional Medical Center, LLC
Goodyear, Arizona 85338
United States
St. Jude Herritage Medical Group
Fullerton, California 92835
United States
Hoag Family Cancer Institute - Hoag Memorial Hospital
Newport Beach, California 92663
United States
Sutter Institute for Medical Research
Sacramento, California 95816
United States
Florida Cancer Affiliates - Ocala Oncology
Ocala, Florida 34474
United States
Moffitt Cancer Center
Tampa, Florida 33612
United States
Northwest Oncology & Hematology
Barrington, Illinois 60010
United States
Elmhurst Hospital Nancy Knowles Cancer Center
Elmhurst, Illinois 60126
United States
Edward Cancer Center
Naperville, Illinois 60540-6766
United States
Cancer Treatment Centers of America (CTCA)
Zion, Illinois 60099
United States
Parkview Packnett Family Cancer Institute
Fort Wayne, Indiana 46845
United States
Franciscan Health Indianapolis
Indianapolis, Indiana 46237
United States
University of Kansas Cancer Center
Westwood, Kansas 66205
United States
Luminis Health Radiation Oncology - Anne Arundel Health System
Annapolis, Missouri 21401
United States
University of Kansas Cancer Center - North
Kansas City, Missouri 64154
United States
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri 64064
United States
University of Kansas Cancer Center - Overland Park
Overland, Missouri 66210
United States
New York Cancer & Blood Specialists (NYCBS)
New Hyde Park, New York 11042
United States
New York Cancer & Blood Specialists (NYCBS)
New York, New York 10028
United States
University of Rochester Medical Center
Rochester, New York 14642
United States
New York Cancer & Blood Specialists (NYCBS)
Shirley, New York 19967
United States
New York Cancer & Blood Specialists (NYCBS)
The Bronx, New York 10469
United States
WakeMed Health & Hospitals
Cary, North Carolina 27518
United States
Abramson Cancer Center
Philadelphia, Pennsylvania 19104
United States
AHN Cancer Center
Pittsburgh, Pennsylvania 15212
United States
Old Parkland Hospital Hematology Oncology Clinic
Dallas, Texas 75235
United States
UT Southwestern Medical Center
Dallas, Texas 75235
United States
DHR Health Oncology Institute
Edinburg, Texas 78539
United States
Houston Methodist Cancer Center
Houston, Texas 77030
United States
Methodist Richardson Cancer Center
Richardson, Texas 75082
United States
Jason Bates at University of Texas Health Science Center
San Antonio, Texas 78229
United States
MultiCare Regional Cancer Center
Auburn, Washington 98001
United States
MultiCare Regional Cancer Center
Gig Harbor, Washington 98335
United States
MultiCare Regional Cancer Center
Puyallup, Washington 98372
United States
MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
Spokane, Washington 99218
United States
MultiCare Institute for Research & Innovation
Tacoma, Washington 98405
United States
Universitaetsklinik fuer Innere Medizin V Innsbruck
Innsbruck, 6020
Austria
University Hospital Salzburg
Salzburg, 5020
Austria
Karl Landsteiner Institut fur Lungenforschung und pneumologische Onkologie c/o Klinik Floridsdorf
Vienna, 1210
Austria
Cliniques universitaires Saint-Luc
Brussels, 1200
Belgium
AZ Maria Middelares - Campus Maria Middelares
Ghent, 9000
Belgium
Fakultni nemocnice Olomouc FNOL
Olomouc, 779 00
Czechia
Nemocnice Agel Ostrava-Vitkovice / Agel Ostrava-Vitkovice Hospital
Ostrava, 70300
Czechia
General University Hospital in Prague
Prague, 12808
Czechia
Centre Hospitalier Intercommunal de Creteil
Créteil, 94010
France
CHU Limoges
Limoges, 87000
France
Hopital Europeen
Marseille, 13003
France
Hopital Prive du Confluent
Nantes, 44277
France
Institut Curie
Paris, 75005
France
CHU de Bordeaux
Pessac, 33604
France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
France
Nouvel Hopital Civil (NHC)
Strasbourg, 67091
France
Evangelische Lungenklinik Berlin
Berlin, 13125
Germany
University Hospital Giessen, ZIM IV
Giessen, 35392
Germany
Krankenhaus Martha-Maria Halle-Dolau
Halle, 06120
Germany
Thoraxklinik Heidelberg
Heidelberg, 69126
Germany
Klinik Loewenstein gGmbH
Löwenstein, 74245
Germany
Pius-Hospital Oldenburg
Oldenburg, 26121
Germany
Farkasgyepui Tudogyogyintezet
Farkasgyepű, 8582
Hungary
Bacs-Kiskun Varmegyei Oktatokorhaz
Kecskemét, 6000
Hungary
Tolna Varmegyei Balassa Janos Korhaz
Szekszárd, 7100
Hungary
Emek Medical Center
Afula, 1834111
Israel
Bnai zion MC
Haifa, 34561
Israel
A.O. SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Alessandria, 15121
Italy
Humanitas Gavazzeni
Bergamo, 24125
Italy
Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna
Ferrara, 44124
Italy
IRCCS - Istituto Romagnolo per lo Studio Dei Tumori, Dino Amadori
Meldola, 47014
Italy
Azienda Sanitaria Territoriale Pesaro Urbino
Pesaro, 61122
Italy
Universita Campus Bio-Medico di Roma (UCBM) - Policlinico Universitario
Roma, 00128
Italy
Ospedale Isola Tiberina Gemelli
Rome, 00186
Italy
Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
Siena, 53100
Italy
Saitama Medical University International Medical Center
Hidaka, Saitama 350-1298
Japan
Rijnstate Ziekenhuis
Arnhem, 6815AD
Netherlands
Medisch Centrum Leeuwarden (MCL) - Oncologisch Centrum Leeuwarden (OCL)
Friesland, 8934 AD
Netherlands
St. Jansdal ziekenhuis
Harderwijk, 3844 DG
Netherlands
St Antonius Ziekenhuis
Utrecht, 3543 AZ
Netherlands
Uniwersytecki Szpital Kliniczny
Poznan, 60-693
Poland
NCCS Singapore
Singapore, 168583
Singapore
Curie Oncology
Singapore, 329563
Singapore
Icon Cancer Centre Singapore (Singapore Oncology Consultants)
Singapore, 574623
Singapore
Hospital Universitario del Vinalopo
Elche, Alicante 3293
Spain
Hospital Universitario Virgen del Rocio
Seville, Andalusia 41013
Spain
Clinica Mi Tres Torres Barcelona - Giromed Institute
Barcelona, Catalonia 8017
Spain
Hospital Universitario de Torrejon
Torrejón de Ardoz, Madrid 28850
Spain
Institut Catala d'Oncologia
Barcelona, 8916
Spain
Hospital Universitario Arnau de Vilanova
Lleida, 25198
Spain
Clinica Universidad de Navarra (Madrid)
Madrid, 28027
Spain
Hospital Ruber Internacional
Madrid, 28034
Spain
Hospital Regional Universitario de Malaga
Málaga, 29010
Spain
Clinica Universidad de Navarra
Pamplona, 31008
Spain
Cantonal Hospital Baden
Baden, 5404
Switzerland
HFR Freiburg-Kantonsspital
Fribourg, 1752
Switzerland
Charing Cross Hospital
London, Greater London
United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, Leicestershire LE1 5WW
United Kingdom
The Royal Marsden NHS Foundation Trust
London, London SW3 6JJ
United Kingdom
Clatterbridge Cancer Centre - Liverpool
Liverpool, Merseyside L7 8YA
United Kingdom
The Royal Marsden NHS Foundation Trust - Sutton
Sutton, Sutton SM2 5PT
United Kingdom