N
← Back to Search
Sponsored

Accelerate Your Clinical Trial Recruitment

Reach thousands of high-intent patients matching your specific inclusion criteria.

Start Campaign
RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: NovoCure GmbH • ClinicalTrials.gov ID: NCT06216301

Registry updated: 2026-10-06
Ad

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Check Eligibility →

Description

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.

Interventions

  • NovoTTF-200T (Device)
    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.
  • Pembrolizumab (Drug)
    Pembrolizumab is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells.
  • Platinum based chemotherapy (Drug)
    Platinum-based chemotherapy is a standard chemotherapy regimen commonly used in the treatment of non-small cell lung cancer

Eligibility criteria

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.

Conditions

Metastatic Non-small Cell Lung Cancer

Locations

  • 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
  • Baptist MD Anderson Cancer Center, Baptist Health — Jacksonville, Florida, 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
  • Parkview Packnett Family Cancer Institute — Fort Wayne, Indiana, 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
  • Houston Methodist Cancer Center — Houston, 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
  • The Ottawa Hospital Cancer Centre General Campus — Ottawa, Ontario, Canada
  • Sunnybrook Health Sciences Center — Toronto, Ontario, Canada
  • 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
  • Kindai University Hospital — Sakai, Osaka, Japan
  • Saitama Medical University International Medical Center — Hidaka, Saitama, Japan
  • Juntendo University — Bunkyo, Tokyo, Japan
  • National Cancer Center Hospital — Chuo-ku, Tokyo, Japan
  • 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
  • Charing Cross Hospital — London, Greater London, United Kingdom
  • University Hospitals of Leicester NHS Trust — Leicester, Leicestershire, United Kingdom
  • The Royal Marsden NHS Foundation Trust — London, London, United Kingdom
  • Clatterbridge Cancer Centre - Liverpool — Liverpool, Merseyside, United Kingdom
  • The Royal Marsden NHS Foundation Trust - Sutton — Sutton, Sutton, United Kingdom
Sponsored

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record