LUNAR-2: TTFields With Pembrolizumab + Platinum-based Chemotherapy for Metastatic NSCLC
NCT ID: NCT06216301
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
734 participants
INTERVENTIONAL
2024-07-31
2028-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1: NovoTTF-200T, Pembrolizumab, and Platinum-based Chemotherapy
Subjects in this arm receive three treatments - TTFields using the NovoTTF-200T device, pembrolizumab, and platinum-based chemotherapy.
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.
Pembrolizumab
Pembrolizumab is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells.
Platinum based chemotherapy
Platinum-based chemotherapy is a standard chemotherapy regimen commonly used in the treatment of non-small cell lung cancer
Arm 2: Pembrolizumab and Platinum-based Chemotherapy
Subjects in this arm receive two treatments - pembrolizumab and platinum-based chemotherapy.
Pembrolizumab
Pembrolizumab is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells.
Platinum based chemotherapy
Platinum-based chemotherapy is a standard chemotherapy regimen commonly used in the treatment of non-small cell lung cancer
Interventions
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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.
Pembrolizumab
Pembrolizumab is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells.
Platinum based chemotherapy
Platinum-based chemotherapy is a standard chemotherapy regimen commonly used in the treatment of non-small cell lung cancer
Eligibility Criteria
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Inclusion Criteria
≥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
* 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.
18 Years
ALL
No
Sponsors
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NovoCure GmbH
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Facility Contacts
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Role: primary
Other Identifiers
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EF-44
Identifier Type: -
Identifier Source: org_study_id