RecruitingPhase 3NCT06216301

LUNAR-2: TTFields With Pembrolizumab + Platinum-based Chemotherapy for Metastatic NSCLC

LUNAR-2: Pivotal, Randomized, Open-Label Study of Tumor Treating Fields (TTFields, 150 kHz) Concomitant With Pembrolizumab and Platinum-based Chemotherapy for the Treatment of Metastatic Non-Small Cell Lung Cancer

Sponsor

NovoCure GmbH

Enrollment

734 participants

Start Date

Jul 31, 2024

Study Type

INTERVENTIONAL

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial (LUNAR-2) is testing a combination of tumor treating fields (TTFields — a wearable device that uses electrical fields to disrupt cancer cell growth), pembrolizumab (an immunotherapy), and platinum-based chemotherapy for patients with stage 4 non-small cell lung cancer (NSCLC) that has spread. It is testing this combination as an initial first-line treatment. **You may be eligible if...** - You are 18 or older (22 or older if in the USA) - You have stage 4 non-small cell lung cancer confirmed by biopsy (squamous or non-squamous) - You have not yet received systemic treatment for your metastatic lung cancer - You are in good physical health and able to carry out daily activities (ECOG 0 or 1) - You have measurable or evaluable cancer in the chest - You are not pregnant or breastfeeding **You may NOT be eligible if...** - Your lung cancer has certain targetable genetic changes (EGFR, ALK, ROS1, or RET mutations/rearrangements) — these patients have other targeted options - You have mixed small cell and non-small cell lung cancer - You have active brain metastases that are untreated or unstable - You have an active autoimmune condition requiring treatment - You have had prior immunotherapy or chemotherapy for your metastatic disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICENovoTTF-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 physically disrupt the rapid cell division exhibited by cancer cells. The physical disruption induced by TTFields can lead to to downstream immunogenic cell death.

DRUGPembrolizumab

Pembrolizumab is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells.

DRUGPlatinum based chemotherapy

Platinum-based chemotherapy is a standard chemotherapy regimen commonly used in the treatment of non-small cell lung cancer

Locations(90)

Central Alabama Research

Birmingham, Alabama, United States

Western Regional Medical Center, LLC

Goodyear, Arizona, United States

St. Jude Herritage Medical Group

Fullerton, California, United States

Hoag Family Cancer Institute - Hoag Memorial Hospital

Newport Beach, California, United States

Sutter Institute for Medical Research

Sacramento, California, United States

Florida Cancer Affiliates - Ocala Oncology

Ocala, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Northwest Oncology & Hematology

Barrington, Illinois, United States

Elmhurst Hospital Nancy Knowles Cancer Center

Elmhurst, Illinois, United States

Edward Cancer Center

Naperville, Illinois, United States

Cancer Treatment Centers of America (CTCA)

Zion, Illinois, United States

Franciscan Health Indianapolis

Indianapolis, Indiana, United States

University of Kansas Cancer Center

Westwood, Kansas, United States

Luminis Health Radiation Oncology - Anne Arundel Health System

Annapolis, Missouri, United States

University of Kansas Cancer Center - North

Kansas City, Missouri, United States

University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, United States

University of Kansas Cancer Center - Overland Park

Overland, Missouri, United States

New York Cancer & Blood Specialists (NYCBS)

New Hyde Park, New York, United States

New York Cancer & Blood Specialists (NYCBS)

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

New York Cancer & Blood Specialists (NYCBS)

Shirley, New York, United States

New York Cancer & Blood Specialists (NYCBS)

The Bronx, New York, United States

WakeMed Health & Hospitals

Cary, North Carolina, United States

Abramson Cancer Center

Philadelphia, Pennsylvania, United States

AHN Cancer Center

Pittsburgh, Pennsylvania, United States

Old Parkland Hospital Hematology Oncology Clinic

Dallas, Texas, United States

UT Southwestern Medical Center

Dallas, Texas, United States

DHR Health Oncology Institute

Edinburg, Texas, United States

Methodist Richardson Cancer Center

Richardson, Texas, United States

Jason Bates at University of Texas Health Science Center

San Antonio, Texas, United States

MultiCare Regional Cancer Center

Auburn, Washington, United States

MultiCare Regional Cancer Center

Gig Harbor, Washington, United States

MultiCare Regional Cancer Center

Puyallup, Washington, United States

MultiCare Deaconess Cancer and Blood Specialty Center - Downtown

Spokane, Washington, United States

MultiCare Institute for Research & Innovation

Tacoma, Washington, United States

Universitaetsklinik fuer Innere Medizin V Innsbruck

Innsbruck, Austria

University Hospital Salzburg

Salzburg, Austria

Karl Landsteiner Institut fur Lungenforschung und pneumologische Onkologie c/o Klinik Floridsdorf

Vienna, Austria

Cliniques universitaires Saint-Luc

Brussels, Belgium

AZ Maria Middelares - Campus Maria Middelares

Ghent, Belgium

Fakultni nemocnice Olomouc FNOL

Olomouc, Czechia

Nemocnice Agel Ostrava-Vitkovice / Agel Ostrava-Vitkovice Hospital

Ostrava, Czechia

General University Hospital in Prague

Prague, Czechia

Centre Hospitalier Intercommunal de Creteil

Créteil, France

CHU Limoges

Limoges, France

Hopital Europeen

Marseille, France

Hopital Prive du Confluent

Nantes, France

Institut Curie

Paris, France

CHU de Bordeaux

Pessac, France

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

Nouvel Hopital Civil (NHC)

Strasbourg, France

Evangelische Lungenklinik Berlin

Berlin, Germany

University Hospital Giessen, ZIM IV

Giessen, Germany

Krankenhaus Martha-Maria Halle-Dolau

Halle, Germany

Thoraxklinik Heidelberg

Heidelberg, Germany

Klinik Loewenstein gGmbH

Löwenstein, Germany

Pius-Hospital Oldenburg

Oldenburg, Germany

Farkasgyepui Tudogyogyintezet

Farkasgyepű, Hungary

Bacs-Kiskun Varmegyei Oktatokorhaz

Kecskemét, Hungary

Tolna Varmegyei Balassa Janos Korhaz

Szekszárd, Hungary

Emek Medical Center

Afula, Israel

Bnai zion MC

Haifa, Israel

A.O. SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Alessandria, Italy

Humanitas Gavazzeni

Bergamo, Italy

Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna

Ferrara, Italy

IRCCS - Istituto Romagnolo per lo Studio Dei Tumori, Dino Amadori

Meldola, Italy

Azienda Sanitaria Territoriale Pesaro Urbino

Pesaro, Italy

Universita Campus Bio-Medico di Roma (UCBM) - Policlinico Universitario

Roma, Italy

Ospedale Isola Tiberina Gemelli

Rome, Italy

Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte

Siena, Italy

Rijnstate Ziekenhuis

Arnhem, Netherlands

Medisch Centrum Leeuwarden (MCL) - Oncologisch Centrum Leeuwarden (OCL)

Friesland, Netherlands

St. Jansdal ziekenhuis

Harderwijk, Netherlands

St Antonius Ziekenhuis

Utrecht, Netherlands

Uniwersytecki Szpital Kliniczny

Poznan, Poland

NCCS Singapore

Singapore, Singapore

Curie Oncology

Singapore, Singapore

Icon Cancer Centre Singapore (Singapore Oncology Consultants)

Singapore, Singapore

Hospital Universitario del Vinalopo

Elche, Alicante, Spain

Hospital Universitario Virgen del Rocio

Seville, Andalusia, Spain

Clinica Mi Tres Torres Barcelona - Giromed Institute

Barcelona, Catalonia, Spain

Hospital Universitario de Torrejon

Torrejón de Ardoz, Madrid, Spain

Institut Catala d'Oncologia

Barcelona, Spain

Hospital Universitario Arnau de Vilanova

Lleida, Spain

Clinica Universidad de Navarra (Madrid)

Madrid, Spain

Hospital Ruber Internacional

Madrid, Spain

Hospital Regional Universitario de Malaga

Málaga, Spain

Clinica Universidad de Navarra

Pamplona, Spain

Cantonal Hospital Baden

Baden, Switzerland

HFR Freiburg-Kantonsspital

Fribourg, Switzerland

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NCT06216301