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RECRUITING

NCT06216301

PHASE3

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

Sponsor: NovoCure GmbH

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

734

Start Date

2024-07-31

Completion Date

2028-10

Last Updated

2025-12-17

Healthy Volunteers

Conditions

Metastatic Non-small Cell Lung Cancer

Interventions

DEVICE

NovoTTF-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.

DRUG

Pembrolizumab

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

DRUG

Platinum based chemotherapy

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

Inclusion Criteria * ≥22 years of age in the USA ≥18 years of age outside of the USA. * Histologically or cytologically diagnosis of stage 4 (according to Version 8 of the American Joint Committee on Cancer \[AJCC\] criteria) non-squamous or squamous NSCLC. * Evaluable (measurable or non-measurable) disease in the thorax per RECIST v1.1. * Have not received prior systemic treatment for their metastatic NSCLC. Subjects who received adjuvant, neoadjuvant chemotherapy or chemoradiotherapy with curative intent for non-metastatic disease are eligible if the therapy was completed at least 12 months prior to the development of metastatic disease. * ECOG Performance Status (PS) of 0-1. * Adequate hematologic and end-organ function o For subjects not receiving therapeutic anticoagulation: INR or aPTT ≤ 1.5 x ULN (unless participant is receiving anticoagulant therapy as long as INR or aPTT is within therapeutic range of intended use of anticoagulants). * A female participant is eligible to participate if she is not pregnant, not breastfeeding * If male subject with a female partner(s) of child-bearing potential, must agree to use an effective contraception * All subjects must sign written informed consent. Exclusion Criteria: All individuals meeting any of the following exclusion criteria will be excluded from study participation: * Mixed small cell and NSCLC histology. * EGFR sensitizing mutation and/or ALK translocation, and/or ROS1 and/or RET targetable gene rearrangement, and/or METex14 skipping mutation, and/or NTRK1/2 gene fusion and/or BRAF V600 mutations directed therapy is indicated or planned for other targeted therapy, where such testing and therapy is locally approved and available. * Has received systemic therapy for metastatic disease. * Had major surgery \<3 weeks prior to randomization * Received radiation therapy to the lung that is \> 30 Gy within 6 months of randomization. * Has received prior radiotherapy within 2 weeks of randomization. Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease. * Is expected to require any other form of antineoplastic therapy while on study. * Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. * Note: Subjects with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded * Has symptomatic Central Nervous System (CNS) metastases and/or carcinomatous meningitis. Subjects with asymptomatic CNS metastases or with previously treated brain metastases may participate provided they were treated before randomization (if applicable) and are neurologically stable and without requirement of steroid treatment for at least 7 days prior to randomization. * Has active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior randomization. Subjects with asthma that require intermittent use of bronchodilators, inhaled steroids, or local steroid injections would not be excluded from the study. * Had prior treatment with any other anti-PD-1, or PD-L1 or PD-L2 agent or an antibody or a small molecule targeting other immuno-regulatory receptors or mechanisms in the 12 months prior to randomization. * Participation in another clinical study with an investigational agent or device during the 4 weeks prior to randomization. * Concurrent treatment with other experimental treatments for NSCLC while in the study. * Has a known sensitivity to any component of the planned systemic therapies (pembrolizumab, cisplatin/carboplatin, pemetrexed/paclitaxel/nab-paclitaxel) . * Pregnant or breastfeeding * Admitted to an institution by administrative or court order.

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (90)