Metastatic Non-small Cell Lung CancerPhase 3LUNAR-2NCT06216301
LUNAR-2: TTFields With Pembrolizumab + Platinum-based Chemotherapy for Metastatic NSCLC
A Phase 3 study testing NovoTTF-200T, Pembrolizumab and Platinum based chemotherapy in people with Metastatic Non-small Cell Lung Cancer, run by NovoCure GmbH at 104 sites in 17 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Non-small Cell Lung Cancer
- What is being tested?
- NovoTTF-200T, Pembrolizumab and Platinum based chemotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 734 participants
- Where
- 104 sitesin 17 countries
- Study dates
- 31 Jul 2024to Oct 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
104 sites in 17 countries. Contact the study team or a site near you to ask about taking part.
104 sites in 17 countries
United States38 sites, 38 recruiting
- Recruiting
Luminis Health Radiation Oncology - Anne Arundel Health System
Annapolis, Missouri, 21401
Rachael Niedelman, 443 659 8685 ext. 802, rniedelman@velocityclinical.com
- Recruiting
MultiCare Regional Cancer Center
Auburn, Washington, 98001
Stacey Macon, 1-253-403-0791, Stacey.macon@multicare.org
- Recruiting
Northwest Oncology & Hematology
Barrington, Illinois, 60010
Khalada Admad, 224-273-8971, khalada.ahmad@ascension.org
- Recruiting
Central Alabama Research
Birmingham, Alabama, 35209
Lorie Szymela, 205-949-1907, lszymela@centralalabamaresearch.com
- Recruiting
WakeMed Health & Hospitals
Cary, North Carolina, 27518
Taylor Childress, 919-350-1700 ext. 14842, tchildress@wakemed.org
- Recruiting
Old Parkland Hospital Hematology Oncology Clinic
Dallas, Texas, 75235
Ebele Mbanugo, 214-645-0326, ebele.mbanugo@utsouthwestern.edu
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75235
Ebele Mbanugo, 214-645-0326, ebele.mbanugo@utsouthwestern.edu
- Recruiting
DHR Health Oncology Institute
Edinburg, Texas, 78539
Edgar Lopez, 956-362-2394, ed.lopez@dhr-rgv.com
- Recruiting
Elmhurst Hospital Nancy Knowles Cancer Center
Elmhurst, Illinois, 60126
Jessica Schnase, 630-646-6029, Jessica.Schnase@EEHealth.org
- Recruiting
Parkview Packnett Family Cancer Institute
Fort Wayne, Indiana, 46845
Brian Chang, Dr., 1-833-724-8326, brian2.chang@parkview.com
Brian Chang
- Recruiting
St. Jude Herritage Medical Group
Fullerton, California, 92835
Larissa Ulloa, 800-627-8106, larissa.lacson@providence.org
- Recruiting
MultiCare Regional Cancer Center
Gig Harbor, Washington, 98335
Stacey Macon, 1-253-403-0791, Stacey.macon@multicare.org
- Recruiting
Western Regional Medical Center, LLC
Goodyear, Arizona, 85338
Janiece Denaro, 1- 623-207-3196, Janiece.Denaro@ctca-hope.com
- Recruiting
Houston Methodist Cancer Center
Houston, Texas, 77030
Nicole Barrios, 713-441-5607, nkbarrios@houstonmethodist.org
Jun Zhang
- Recruiting
Franciscan Health Indianapolis
Indianapolis, Indiana, 46237
Olivia Martin, 317-528-7822, Olivia.martin@franciscanalliance.org
- Recruiting
Baptist MD Anderson Cancer Center, Baptist Health
Jacksonville, Florida, 32207
Vanessa Tolsa, 305-915-6496, vanessa.tolsa@bmcjax.com
John Vu
- Recruiting
University of Kansas Cancer Center - North
Kansas City, Missouri, 64154
KUCC Navigation, 913-588-3671, kucc_navigation@kumc.edu
- Recruiting
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, 64064
KUCC Navigation, 913-588-3671, kucc_navigation@kumc.edu
- Recruiting
Edward Cancer Center
Naperville, Illinois, 60540-6766
Jessica Schnase, 630-646-6029, Jessica.Schnase@EEHealth.org
- Recruiting
New York Cancer & Blood Specialists (NYCBS)
New Hyde Park, New York, 11042
Laura Parisi, 631-675-5146, lparisi@nycancer.com
- Recruiting
New York Cancer & Blood Specialists (NYCBS)
New York, New York, 10028
Laura Parisi, 631-675-5146, lparisi@nycancer.com
- Recruiting
Hoag Family Cancer Institute - Hoag Memorial Hospital
Newport Beach, California, 92663
Patrice Jones, 949-764-5501, Patrice.Jones@hoag.org
- Recruiting
Florida Cancer Affiliates - Ocala Oncology
Ocala, Florida, 34474
Megan Cerrato, 352-547-1943, Megan.Cerrato@usoncology.com
- Recruiting
University of Kansas Cancer Center - Overland Park
Overland, Missouri, 66210
KUCC Navigation, 913-588-3671, kucc_navigation@kumc.edu
- Recruiting
Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
Ryan Roddy, 267-408-3199, ryan.roddy@pennmedicine.upenn.edu
- Recruiting
AHN Cancer Center
Pittsburgh, Pennsylvania, 15212
Ariel Lopez-Chavez, 412-518-5025, clinicaltrials@ahn.org
- Recruiting
MultiCare Regional Cancer Center
Puyallup, Washington, 98372
Stacey Macon, 1-253-403-0791, Stacey.macon@multicare.org
- Recruiting
Methodist Richardson Cancer Center
Richardson, Texas, 75082
Crystee Cooper, 214-947-1280, ClinicalResearch@mhd.com
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14642
Sierra Napoli, 585-276-0648, Sierra_Napoli@URMC.Rochester.edu
- Recruiting
Sutter Institute for Medical Research
Sacramento, California, 95816
Clara Dunn, 1-916-454-6931, Clara.Dunn@sutterhealth.org
- Recruiting
Jason Bates at University of Texas Health Science Center
San Antonio, Texas, 78229
Epp Goodwin, 210-450-5798, goodwine@uthscsa.edu
- Recruiting
New York Cancer & Blood Specialists (NYCBS)
Shirley, New York, 19967
Laura Parisi, 631-675-5146, lparisi@nycancer.com
- Recruiting
MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
Spokane, Washington, 99218
Rachel Smith, 1-509-838-2531, rachel.smith@multicare.org
- Recruiting
MultiCare Institute for Research & Innovation
Tacoma, Washington, 98405
Stacey Macon, 1-253-403-0791, Stacey.macon@multicare.org
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Maya Douglas, 813-745-0969, maya.douglas@moffitt.org
- Recruiting
New York Cancer & Blood Specialists (NYCBS)
The Bronx, New York, 10469
Laura Parisi, 631-675-5146, lparisi@nycancer.com
- Recruiting
University of Kansas Cancer Center
Westwood, Kansas, 66205
KUCC Navigation, 913-588-3671, kucc_navigation@kumc.edu
- Recruiting
Cancer Treatment Centers of America (CTCA)
Zion, Illinois, 60099
Sylvia Schneiderman, 1-847-746-6983, sylvia.schneiderman@coh.org
Spain10 sites, 10 recruiting
- Recruiting
Clinica Mi Tres Torres Barcelona - Giromed Institute
Barcelona, Catalonia, 8017
Carlos Cabrera Galvez, +34 932 287 445, ccabrera@uomi.es
- Recruiting
Institut Catala d'Oncologia
Barcelona, 8916
Enric Carcereny Costa, +34 677 254 583, ecarcereny@iconcologia.net
- Recruiting
Hospital Universitario del Vinalopo
Elche, Alicante, 3293
Eugenio Palomares Garcia, +34 966679800, epalomares@vinaloposalud.com
- Recruiting
Hospital Universitario Arnau de Vilanova
Lleida, 25198
Alberto Rodrigo Caceres, +34 973 003 754, alberto.rcaceres@gmail.com
- Recruiting
Clinica Universidad de Navarra (Madrid)
Madrid, 28027
Miguel Fernandez de Sanmamed Gutierrez, +34 948255400, msanmamed@unav.es
- Recruiting
Hospital Ruber Internacional
Madrid, 28034
Antonio Calles Blanco, +34 913875090, antonio.calles.co@quironsalud.es
- Recruiting
Hospital Regional Universitario de Malaga
Málaga, 29010
Airam Padilla Alvarez, +34 951 308 130, airampadillaalvarez@gmail.com
- Recruiting
Clinica Universidad de Navarra
Pamplona, 31008
Miguel Fernandez de Sanmamed Gutierrez, +34 948255400, msanmamed@unav.es
- Recruiting
Hospital Universitario Virgen del Rocio
Seville, Andalusia, 41013
Carlos Cabrera, +34 932 287 445, ccabrera@uomi.es
- Recruiting
Hospital Universitario de Torrejon
Torrejón de Ardoz, Madrid, 28850
Luis Cabezon Gutierrez, +34 916262626, lcabezon@torrejonsalud.com
France8 sites, 8 recruiting
- Recruiting
Centre Hospitalier Intercommunal de Creteil
Créteil, 94010
Christos Chouaid, +33 1 57 02 20 70, christos.chouaid@chicreteil.fr
- Recruiting
CHU Limoges
Limoges, 87000
Thomas Egenod, +33 5 55 05 68 92, Thomas.Egenod@chu-limoges.fr
Thomas Egenod
- Recruiting
Hopital Europeen
Marseille, 13003
Remi Bonetto, +33 4 13 42 74 82, drc-he@hopital-europeen.fr
- Recruiting
Hopital Prive du Confluent
Nantes, 44277
Cyriac Blonz, +33 2 28 27 20 88, BLONZ.CYRIAC@groupeconfluent.fr
Cyriac Blonz
- Recruiting
Institut Curie
Paris, 75005
Nicolas Girard, 33144324677, nicolas.girard2@curie.fr
- Recruiting
CHU de Bordeaux
Pessac, 33604
Claire Bardel, +33 5 57 65 63 38, claire.bardel@chu-bordeaux.fr
- Recruiting
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
Sebastien Couraud, +33 (0)4 78 86 44 01, sebastien.couraud@chu-lyon.fr
- Recruiting
Nouvel Hopital Civil (NHC)
Strasbourg, 67091
Celine Mascaux, 33-3-69 55 06 44, celine.mascaux@chru-strasbourg.fr
Italy8 sites, 8 recruiting
- Recruiting
A.O. SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Alessandria, 15121
Pier Luigi Piovano, 00390131208345, plpiovano@ospedale.al.it
Clinical Trial Center, +39 013120 6893, clinicaltrialcenter@ospedale.al.it
- Recruiting
Humanitas Gavazzeni
Bergamo, 24125
Chiara Catania, 00390354204106, chiara.catania@gavazzeni.it
- Recruiting
Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna
Ferrara, 44124
Luana Calabro, 00390532239661, luana.calabro@unife.it
- Recruiting
IRCCS - Istituto Romagnolo per lo Studio Dei Tumori, Dino Amadori
Meldola, 47014
Angelo Delmonte, +39 0543 739100, angelo.delmonte@irst.emr.it
- Recruiting
Azienda Sanitaria Territoriale Pesaro Urbino
Pesaro, 61122
Rita Chiari, +39 331 689 3387, rita.chiari@sanita.marche.it
- Recruiting
Universita Campus Bio-Medico di Roma (UCBM) - Policlinico Universitario
Roma, 00128
Giuseppe Tonini, +39 06 225411000, g.tonini@policlinicocampus.it
- Recruiting
Ospedale Isola Tiberina Gemelli
Rome, 00186
Emilio Bria, +39 06 6837 0271, emilio.bria@policlinicogemelli.it
- Recruiting
Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
Siena, 53100
Michele Maio, 00390577586336, maio@unisi.it
Germany6 sites, 6 recruiting
- Recruiting
Evangelische Lungenklinik Berlin
Berlin, 13125
Norman von-Palubitzki, +49 30 9480 2569, Norman.von-Palubitzki@jsd.de
- Recruiting
University Hospital Giessen, ZIM IV
Giessen, 35392
Anika Holzapfel, +49 641 985 59263, Anika.Holzapfel@uniklinikum-giessen.de
- Recruiting
Krankenhaus Martha-Maria Halle-Dolau
Halle, 06120
Franziska Gebauer, +49 345 559 1434, franziska.gebauer@martha-maria.de
Wolfgang Schuette
- Recruiting
Thoraxklinik Heidelberg
Heidelberg, 69126
Helge Bischoff, +49 6221 396 1350, Studienkoordination-Onkologie.THOR@med.uni-heidelberg.de
- Recruiting
Klinik Loewenstein gGmbH
Löwenstein, 74245
Nicolyn Roessel, +49 7130 15 6226, Nicolyn.Roessel@slk-kliniken.de
- Recruiting
Pius-Hospital Oldenburg
Oldenburg, 26121
Frank Griesinger, +49 441 229 1611, Frank.Griesinger@Pius-Hospital.de
United Kingdom5 sites, 5 recruiting
- Recruiting
University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, LE1 5WW
Clare Belcher, 01162586935, clare.belcher2@nhs.net
Sean Dulloo
- Recruiting
Clatterbridge Cancer Centre - Liverpool
Liverpool, Merseyside, L7 8YA
William McCaig, 07795 129946, william.mccaig1@nhs.net
Carles Escriu
- Recruiting
Charing Cross Hospital
London, Greater London
Denebeth Calla, 020-331-10291, Denebeth.calla@nhs.net
Waleed Mohammed
- Recruiting
The Royal Marsden NHS Foundation Trust
London, London, SW3 6JJ
Michael Davidson, +44 20 7352 8171, lung.trials@rmh.nhs.uk
- Recruiting
The Royal Marsden NHS Foundation Trust - Sutton
Sutton, Sutton, SM2 5PT
Michael Davidson, +44 20 7352 8171, lung.trials@rmh.nhs.uk
Japan4 sites, 4 recruiting
- Recruiting
Juntendo University
Bunkyo, Tokyo, 113-8431
Takehito Shukuya, 81-3-3814-5672, tshukuya@juntendo.ac.jp
Takehito Shukuya
- Recruiting
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045
Hidehito Horinouchi, 81-3542-2511, hhorinou@ncc.go.jp
Hidehito Horinouchi
- Recruiting
Saitama Medical University International Medical Center
Hidaka, Saitama, 350-1298
Saitama Medical University International Medical Center, 042-984-4183, chikenme@saitama-med.ac.jp
- Recruiting
Kindai University Hospital
Sakai, Osaka, 590-0197
Hidetoshi Hayashi, 81-72-288-7222, hidet31@med.kindai.ac.jp
Hidetoshi Hayashi
Netherlands4 sites, 4 recruiting
- Recruiting
Rijnstate Ziekenhuis
Arnhem, 6815AD
Siyar Demir, +31 88 005 6730, sdemir@rijnstate.nl
- Recruiting
Medisch Centrum Leeuwarden (MCL) - Oncologisch Centrum Leeuwarden (OCL)
Friesland, 8934 AD
Johanna Hellinga, 0031 58 286 3768, Johanna.Post@mcl.nl
- Recruiting
St. Jansdal ziekenhuis
Harderwijk, 3844 DG
Martine Lammens, +31 341 463 911, m.lammens@mediflowresearch.nl
- Recruiting
St Antonius Ziekenhuis
Utrecht, 3543 AZ
Lisanne Kastelijn, 31-88-3201572, l.kastelijn1@antoniusziekenhuis.nl
Austria3 sites, 3 recruiting
- Recruiting
Universitaetsklinik fuer Innere Medizin V Innsbruck
Innsbruck, 6020
Florian Kocher, +43512504-0, florian.kocher@i-med.ac.at
- Recruiting
University Hospital Salzburg
Salzburg, 5020
Richard Greil, 43-662-4482 4100, r.greil@salk.at
- Recruiting
Karl Landsteiner Institut fur Lungenforschung und pneumologische Onkologie c/o Klinik Floridsdorf
Vienna, 1210
Maximilian Hochmair, +43 1 27700 3855, maximilian.hochmair@gesundheitsverbund.at
Czechia3 sites, 3 recruiting
- Recruiting
Fakultni nemocnice Olomouc FNOL
Olomouc, 779 00
Bohuslav Melichar, +420588444295, bohuslav.melichar@fnol.cz
- Recruiting
Nemocnice Agel Ostrava-Vitkovice / Agel Ostrava-Vitkovice Hospital
Ostrava, 70300
Jaromir Roubec, +420595633400, jaromir.roubec@vtn.agel.cz
- Recruiting
General University Hospital in Prague
Prague, 12808
Milada Zemanova, +420224966405, milada.zemanova@vfn.cz
Hungary3 sites, 3 recruiting
- Recruiting
Farkasgyepui Tudogyogyintezet
Farkasgyepű, 8582
Zsolt Kiraly, +36 20 926 4476, dr.kiraly.zsolt@gmail.com
- Recruiting
Bacs-Kiskun Varmegyei Oktatokorhaz
Kecskemét, 6000
Zsuzsanna Kelemen, +36 20 588 1072, study.zsuzsannadrkelemen@gmail.com
- Recruiting
Tolna Varmegyei Balassa Janos Korhaz
Szekszárd, 7100
Yousuf Al-Farhat, +36 30 644 1744, yalfarhat@gmail.com
Singapore3 sites, 3 recruiting
- Recruiting
NCCS Singapore
Singapore, 168583
+65 6436 8000, clinical.trials@nccs.com.sg
- Recruiting
Curie Oncology
Singapore, 329563
Toh Chee Keong, +65 6259 5538, info@curieresearch.sg
- Recruiting
Icon Cancer Centre Singapore (Singapore Oncology Consultants)
Singapore, 574623
Daniel Chan, 6604 9919, daniel.chan@icon.team
Belgium2 sites, 2 recruiting
- Recruiting
Cliniques universitaires Saint-Luc
Brussels, 1200
Rachel Galot, 32-2-764 1037, rachel.galot@uclouvain.be
- Recruiting
AZ Maria Middelares - Campus Maria Middelares
Ghent, 9000
Paul Germonpre, +3292468400, Paul.germonpre@mijnziekenhuis.be
Canada2 sites, 2 recruiting
- Recruiting
The Ottawa Hospital Cancer Centre General Campus
Ottawa, Ontario, K1H 8L6
Garth Nicholas, 613-737-7700 ext. 70175, gnicholas@toh.ca
Garth Nicholas
- Recruiting
Sunnybrook Health Sciences Center
Toronto, Ontario, M4N 3M5
Vaishali Krishnanandan, 416-480-5000 ext. 67955, vaishali.krishnanandan@sunnybrook.ca
Susanna Cheng
Israel2 sites, 2 recruiting
- Recruiting
Emek Medical Center
Afula, 1834111
Gil Bar Sela, 972-50-2061207, gil_ba@clalit.org.il
- Recruiting
Bnai zion MC
Haifa, 34561
Abed Agbarya, 972-48-359359, abed.agbarya@b-zion.org.il
Switzerland2 sites, 2 recruiting
- Recruiting
Cantonal Hospital Baden
Baden, 5404
Sacha Rothschild, +41 56 486 27 62, klinische_forschung.onkologie@ksb.ch
- Recruiting
HFR Freiburg-Kantonsspital
Fribourg, 1752
Alessandra Curioni-Fontecedro, +41 26 306 20 10, Alessandra.curioni-fontecedro@h-fr.ch
Alessandra Curioni-Fontecedro
Poland1 site, 1 recruiting
- Recruiting
Uniwersytecki Szpital Kliniczny
Poznan, 60-693
Rodryg Ramlau, 00 48 61 854 90 40, rodryg.ramlau@usk.poznan.pl
About this study
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
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.
Read the 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:
- Histology - Squamous vs. non-squamous
- PD-L1 expression level - TPS <1% vs. 1% ≤TPS <50% vs. TPS ≥50%
- 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.
- Conditions
- Metastatic Non-small Cell Lung Cancer
- Being tested
- NovoTTF-200T, Pembrolizumab, Platinum based chemotherapy
- Keywords
- NSCLC, Metastatic
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NovoTTF-200TDevice
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.
PembrolizumabDrug
Pembrolizumab is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells.
Platinum based chemotherapyDrug
Platinum-based chemotherapy is a standard chemotherapy regimen commonly used in the treatment of non-small cell lung cancer
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: NovoTTF-200T, Pembrolizumab, and Platinum-based Chemotherapy | Experimental | Subjects in this arm receive three treatments - TTFields using the NovoTTF-200T device, pembrolizumab, and platinum-based chemotherapy. Receives: Device: NovoTTF-200T; Drug: Pembrolizumab; Drug: Platinum based chemotherapy |
| Arm 2: Pembrolizumab and Platinum-based Chemotherapy | Active comparator | Subjects in this arm receive two treatments - pembrolizumab and platinum-based chemotherapy. Receives: Drug: Pembrolizumab; Drug: Platinum based chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
To compare OS in subjects treated with TTFields concomitant with pembrolizumab and platinum-based chemotherapy compared to OS of those treated with pembrolizumab and platinum-based chemotherapy alone (superiority analysis).
Measured: up to 6 years
Progression Free Survival (PFS)
To compare PFS per RECIST v1.1 as assessed by BICR, in subjects treated with TTFields concomitant with pembrolizumab and platinum-based chemotherapy compared to PFS of those treated with pembrolizumab and platinum-based chemotherapy alone (superiority analysis)
Measured: up to 6 years
Secondary outcomes (14)
Progression Free Survival (PFS)
Progression Free Survival (PFS) per RECIST v1.1 as assessed by BICR, in subjects treated with TTFields concomitant with pembrolizumab and platinum-based chemotherapy and of those treated with pembrolizumab and platinum-based chemotherapy alone according to histology.
Measured: up to 6 years
Overall Survival (OS)
Overall Survival (OS) in subjects treated with TTFields concomitant with pembrolizumab and platinum-based chemotherapy and of those treated with pembrolizumab and platinum-based chemotherapy alone according to histology.
Measured: up to 6 years
Progression Free Survival (PFS)
PFS per RECIST v1.1 as assessed by BICR, in subjects treated with TTFields concomitant with pembrolizumab and platinum-based chemotherapy and of those treated with pembrolizumab and platinum-based chemotherapy alone according to PD-L1 Tumor Proportion Score (TPS).
Measured: up to 6 years
Overall Survival (OS)
OS in subjects treated with TTFields concomitant with pembrolizumab and platinum-based chemotherapy and of those treated with pembrolizumab and platinum-based chemotherapy alone according to PD-L1 TPS.
Measured: up to 6 years
Progression Free Survival (PFS)
PFS per RECIST v1.1 as assessed by BICR at 6 (PFS6), 12 (PFS12), 24 (PFS24), and 36 (PFS36) months in subjects treated with TTFields concomitant with pembrolizumab and platinum-based chemotherapy and of those treated with pembrolizumab and platinum-based chemotherapy alone.
Measured: up to 6 years
1, 2, and 3-year Survival Rate
1-, 2- and 3-year survival rate in subjects treated with TTFields concomitant with pembrolizumab and platinum-based chemotherapy and of those treated with pembrolizumab and platinum-based chemotherapy alone.
Measured: up to 6 years
Objective Response Rate (ORR)
Objective Response Rate (ORR) per RECIST v1.1 as assessed by BICR, in subjects treated with TTFields concomitant with pembrolizumab and platinum-based chemotherapy and of those treated with pembrolizumab and platinum-based chemotherapy alone.
Measured: up to 6 years
Duration of Response (DoR)
Duration of Response (DoR) per RECIST v1.1 as assessed by BICR, in subjects treated with TTFields concomitant with pembrolizumab and platinum-based chemotherapy and of those treated with pembrolizumab and platinum-based chemotherapy alone.
Measured: up to 6 years
Disease Control Rate (DCR)
Disease Control Rate (DCR) per RECIST v1.1 as assessed by BICR, in subjects treated with TTFields concomitant with pembrolizumab and platinum-based chemotherapy and of those treated with pembrolizumab and platinum-based chemotherapy alone.
Measured: up to 6 years
Progression Free Survival (PFS)
PFS per RECIST v1.1 as assessed by the investigator, in subjects treated with TTFields concomitant with pembrolizumab and platinum-based chemotherapy and of those treated with pembrolizumab and platinum-based chemotherapy alone.
Measured: up to 6 years
Objective Response Rate (ORR)
ORR per RECIST v1.1 as assessed by the investigator, in subjects treated with TTFields concomitant with pembrolizumab and platinum-based chemotherapy and of those treated with pembrolizumab and platinum-based chemotherapy alone.
Measured: up to 6 years
Duration of Response (DoR)
DoR per RECIST v1.1 as assessed by the investigator, in subjects treated with TTFields concomitant with pembrolizumab and platinum-based chemotherapy and of those treated with pembrolizumab and platinum-based chemotherapy alone.
Measured: up to 6 years
Disease Control Rate (DCR)
DCR per RECIST v1.1 as assessed by the investigator, in subjects treated with TTFields concomitant with pembrolizumab and platinum-based chemotherapy and of those treated with pembrolizumab and platinum-based chemotherapy alone.
Measured: up to 6 years
Adverse Events
Toxicity profile of TTFields concomitant with pembrolizumab and platinum-based chemotherapy. The analyses will be performed based on the incidence, severity, frequency of adverse events, and their association with study treatments.
Measured: up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start31 Jul 2024
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 734 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NovoCure GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216301
- Sponsor's protocol ID
- EF-44
- Acronym
- LUNAR-2
- Status last verified
- Dec 2025
- First submitted
- 29 Dec 2023
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06216301
- Acronym / sponsor ID
- LUNAR-2 / EF-44
- Conditions
- Metastatic Non-small Cell Lung Cancer
- Keywords
- NSCLC, Metastatic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 734 participants (estimated)
- Lead sponsor
- NovoCure GmbHIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Histology - Squamous vs. non-squamous
- PD-L1 expression level - TPS <1% vs. 1% ≤TPS <50% vs. TPS ≥50%
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: NovoTTF-200T, Pembrolizumab, and Platinum-based Chemotherapy | Experimental | Device: NovoTTF-200T, Drug: Pembrolizumab, Drug: Platinum based chemotherapySubjects in this arm receive three treatments - TTFields using the NovoTTF-200T device, pembrolizumab, and platinum-based chemotherapy. |
| Arm 2: Pembrolizumab and Platinum-based Chemotherapy | Active comparator | Drug: Pembrolizumab, Drug: Platinum based chemotherapySubjects in this arm receive two treatments - pembrolizumab and platinum-based chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- ≥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.
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NovoTTF-200TThe 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. | Device | Arm 1: NovoTTF-200T, Pembrolizumab, and Platinum-based Chemotherapy |
| PembrolizumabPembrolizumab is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells. | Drug | Arm 1: NovoTTF-200T, Pembrolizumab, and Platinum-based Chemotherapy, Arm 2: Pembrolizumab and Platinum-based Chemotherapy |
| Platinum based chemotherapyPlatinum-based chemotherapy is a standard chemotherapy regimen commonly used in the treatment of non-small cell lung cancer | Drug | Arm 1: NovoTTF-200T, Pembrolizumab, and Platinum-based Chemotherapy, Arm 2: Pembrolizumab and Platinum-based Chemotherapy |
Primary outcome
Overall Survival (OS)
Time frame: up to 6 years
To compare OS in subjects treated with TTFields concomitant with pembrolizumab and platinum-based chemotherapy compared to OS of those treated with pembrolizumab and platinum-based chemotherapy alone (superiority analysis).
Progression Free Survival (PFS)
Time frame: up to 6 years
To compare PFS per RECIST v1.1 as assessed by BICR, in subjects treated with TTFields concomitant with pembrolizumab and platinum-based chemotherapy compared to PFS of those treated with pembrolizumab and platinum-based chemotherapy alone (superiority analysis)
14 secondary outcomes
Progression Free Survival (PFS)
Time frame: up to 6 years
Overall Survival (OS)
Time frame: up to 6 years
Progression Free Survival (PFS)
Time frame: up to 6 years
Overall Survival (OS)
Time frame: up to 6 years
Progression Free Survival (PFS)
Time frame: up to 6 years
1, 2, and 3-year Survival Rate
Time frame: up to 6 years
Objective Response Rate (ORR)
Time frame: up to 6 years
Duration of Response (DoR)
Time frame: up to 6 years
Disease Control Rate (DCR)
Time frame: up to 6 years
Progression Free Survival (PFS)
Time frame: up to 6 years
Objective Response Rate (ORR)
Time frame: up to 6 years
Duration of Response (DoR)
Time frame: up to 6 years
Disease Control Rate (DCR)
Time frame: up to 6 years
Adverse Events
Time frame: up to 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Western Regional Medical Center, LLC
Goodyear, United States
104 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NovoTTF-200T, Pembrolizumab and Platinum based chemotherapy in people with Metastatic Non-small Cell Lung Cancer, run by NovoCure GmbH at 104 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 104 sites in United States, Spain, France, Italy, Germany and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: up to 6 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.