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LUNAR-2: TTFields med Pembrolizumab + platinbaseret kemoterapi til metastatisk NSCLC (LUNAR-2)

1. oktober 2026 opdateret af: NovoCure GmbH

LUNAR-2: Pivotal, randomiseret, åben-label undersøgelse af tumorbehandlingsfelter (TTFields, 150 kHz) samtidig med Pembrolizumab og platinbaseret kemoterapi til behandling af metastatisk ikke-småcellet lungekræft

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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:

  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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

734

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Belgien
      • Brussels, Belgien, 1200
        • Rekruttering
        • Cliniques universitaires Saint-Luc
        • Kontakt:
      • Ghent, Belgien, 9000
  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Rekruttering
        • The Ottawa Hospital Cancer Centre General Campus
        • Ledende efterforsker:
          • Garth Nicholas
        • Kontakt:
      • Toronto, Ontario, Canada, M4N 3M5
        • Rekruttering
        • Sunnybrook Health Sciences Center
        • Kontakt:
        • Ledende efterforsker:
          • Susanna Cheng
  • Det Forenede Kongerige
    • Greater London
      • London, Greater London, Det Forenede Kongerige
        • Rekruttering
        • Charing Cross Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Waleed Mohammed
    • Leicestershire
      • Leicester, Leicestershire, Det Forenede Kongerige, LE1 5WW
        • Rekruttering
        • University Hospitals of Leicester NHS Trust
        • Kontakt:
        • Ledende efterforsker:
          • Sean Dulloo
    • London
      • London, London, Det Forenede Kongerige, SW3 6JJ
        • Rekruttering
        • The Royal Marsden NHS Foundation Trust
        • Kontakt:
    • Merseyside
      • Liverpool, Merseyside, Det Forenede Kongerige, L7 8YA
        • Rekruttering
        • Clatterbridge Cancer Centre - Liverpool
        • Ledende efterforsker:
          • Carles Escriu
        • Kontakt:
    • Sutton
      • Sutton, Sutton, Det Forenede Kongerige, SM2 5PT
        • Rekruttering
        • The Royal Marsden NHS Foundation Trust - Sutton
        • Kontakt:
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35209
    • Arizona
      • Goodyear, Arizona, Forenede Stater, 85338
        • Rekruttering
        • Western Regional Medical Center, LLC
        • Kontakt:
    • California
      • Fullerton, California, Forenede Stater, 92835
      • Newport Beach, California, Forenede Stater, 92663
        • Rekruttering
        • Hoag Family Cancer Institute - Hoag Memorial Hospital
        • Kontakt:
      • Sacramento, California, Forenede Stater, 95816
        • Rekruttering
        • Sutter Institute for Medical Research
        • Kontakt:
    • Florida
      • Jacksonville, Florida, Forenede Stater, 32207
        • Rekruttering
        • Baptist MD Anderson Cancer Center, Baptist Health
        • Kontakt:
        • Ledende efterforsker:
          • John Vu
      • Ocala, Florida, Forenede Stater, 34474
        • Rekruttering
        • Florida Cancer Affiliates - Ocala Oncology
        • Kontakt:
      • Tampa, Florida, Forenede Stater, 33612
    • Illinois
      • Barrington, Illinois, Forenede Stater, 60010
      • Elmhurst, Illinois, Forenede Stater, 60126
        • Rekruttering
        • Elmhurst Hospital Nancy Knowles Cancer Center
        • Kontakt:
      • Naperville, Illinois, Forenede Stater, 60540-6766
      • Zion, Illinois, Forenede Stater, 60099
        • Rekruttering
        • Cancer Treatment Centers of America (CTCA)
        • Kontakt:
    • Indiana
      • Fort Wayne, Indiana, Forenede Stater, 46845
        • Rekruttering
        • Parkview Packnett Family Cancer Institute
        • Ledende efterforsker:
          • Brian Chang
        • Kontakt:
      • Indianapolis, Indiana, Forenede Stater, 46237
    • Kansas
      • Westwood, Kansas, Forenede Stater, 66205
        • Rekruttering
        • University of Kansas Cancer Center
        • Kontakt:
    • Missouri
      • Annapolis, Missouri, Forenede Stater, 21401
        • Rekruttering
        • Luminis Health Radiation Oncology - Anne Arundel Health System
        • Kontakt:
      • Kansas City, Missouri, Forenede Stater, 64154
        • Rekruttering
        • University of Kansas Cancer Center - North
        • Kontakt:
      • Lee's Summit, Missouri, Forenede Stater, 64064
        • Rekruttering
        • University of Kansas Cancer Center - Lee's Summit
        • Kontakt:
      • Overland, Missouri, Forenede Stater, 66210
        • Rekruttering
        • University of Kansas Cancer Center - Overland Park
        • Kontakt:
    • New York
      • New Hyde Park, New York, Forenede Stater, 11042
        • Rekruttering
        • New York Cancer & Blood Specialists (NYCBS)
        • Kontakt:
      • New York, New York, Forenede Stater, 10028
        • Rekruttering
        • New York Cancer & Blood Specialists (NYCBS)
        • Kontakt:
      • Rochester, New York, Forenede Stater, 14642
      • Shirley, New York, Forenede Stater, 19967
        • Rekruttering
        • New York Cancer & Blood Specialists (NYCBS)
        • Kontakt:
      • The Bronx, New York, Forenede Stater, 10469
        • Rekruttering
        • New York Cancer & Blood Specialists (NYCBS)
        • Kontakt:
    • North Carolina
      • Cary, North Carolina, Forenede Stater, 27518
        • Rekruttering
        • WakeMed Health & Hospitals
        • Kontakt:
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
      • Pittsburgh, Pennsylvania, Forenede Stater, 15212
        • Rekruttering
        • AHN Cancer Center
        • Kontakt:
    • Texas
      • Dallas, Texas, Forenede Stater, 75235
      • Dallas, Texas, Forenede Stater, 75235
      • Edinburg, Texas, Forenede Stater, 78539
        • Rekruttering
        • DHR Health Oncology Institute
        • Kontakt:
      • Houston, Texas, Forenede Stater, 77030
        • Rekruttering
        • Houston Methodist Cancer Center
        • Ledende efterforsker:
          • Jun Zhang
        • Kontakt:
      • Richardson, Texas, Forenede Stater, 75082
        • Rekruttering
        • Methodist Richardson Cancer Center
        • Kontakt:
      • San Antonio, Texas, Forenede Stater, 78229
        • Rekruttering
        • Jason Bates at University of Texas Health Science Center
        • Kontakt:
    • Washington
      • Auburn, Washington, Forenede Stater, 98001
        • Rekruttering
        • MultiCare Regional Cancer Center
        • Kontakt:
      • Gig Harbor, Washington, Forenede Stater, 98335
        • Rekruttering
        • MultiCare Regional Cancer Center
        • Kontakt:
      • Puyallup, Washington, Forenede Stater, 98372
        • Rekruttering
        • MultiCare Regional Cancer Center
        • Kontakt:
      • Spokane, Washington, Forenede Stater, 99218
        • Rekruttering
        • MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
        • Kontakt:
      • Tacoma, Washington, Forenede Stater, 98405
        • Rekruttering
        • MultiCare Institute for Research & Innovation
        • Kontakt:
  • Frankrig
      • Créteil, Frankrig, 94010
        • Rekruttering
        • Centre Hospitalier Intercommunal de Creteil
        • Kontakt:
      • Limoges, Frankrig, 87000
        • Rekruttering
        • CHU Limoges
        • Ledende efterforsker:
          • Thomas Egenod
        • Kontakt:
      • Marseille, Frankrig, 13003
      • Nantes, Frankrig, 44277
        • Rekruttering
        • Hopital Prive du Confluent
        • Ledende efterforsker:
          • Cyriac Blonz
        • Kontakt:
      • Paris, Frankrig, 75005
      • Pessac, Frankrig, 33604
      • Pierre-Bénite, Frankrig, 69495
      • Strasbourg, Frankrig, 67091
  • Holland
      • Arnhem, Holland, 6815AD
        • Rekruttering
        • Rijnstate Ziekenhuis
        • Kontakt:
      • Friesland, Holland, 8934 AD
        • Rekruttering
        • Medisch Centrum Leeuwarden (MCL) - Oncologisch Centrum Leeuwarden (OCL)
        • Kontakt:
      • Harderwijk, Holland, 3844 DG
      • Utrecht, Holland, 3543 AZ
  • Israel
      • Afula, Israel, 1834111
        • Rekruttering
        • Emek Medical Center
        • Kontakt:
      • Haifa, Israel, 34561
  • Italien
      • Alessandria, Italien, 15121
      • Bergamo, Italien, 24125
      • Ferrara, Italien, 44124
        • Rekruttering
        • Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna
        • Kontakt:
      • Meldola, Italien, 47014
        • Rekruttering
        • IRCCS - Istituto Romagnolo per lo Studio Dei Tumori, Dino Amadori
        • Kontakt:
      • Pesaro, Italien, 61122
        • Rekruttering
        • Azienda Sanitaria Territoriale Pesaro Urbino
        • Kontakt:
      • Roma, Italien, 00128
        • Rekruttering
        • Universita Campus Bio-Medico di Roma (UCBM) - Policlinico Universitario
        • Kontakt:
      • Rome, Italien, 00186
      • Siena, Italien, 53100
        • Rekruttering
        • Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
        • Kontakt:
          • Michele Maio
          • Telefonnummer: 00390577586336
          • E-mail: maio@unisi.it
  • Japan
    • Osaka
      • Sakai, Osaka, Japan, 590-0197
        • Rekruttering
        • Kindai University Hospital
        • Ledende efterforsker:
          • Hidetoshi Hayashi
        • Kontakt:
    • Saitama
      • Hidaka, Saitama, Japan, 350-1298
        • Rekruttering
        • Saitama Medical University International Medical Center
        • Kontakt:
    • Tokyo
      • Bunkyo, Tokyo, Japan, 113-8431
        • Rekruttering
        • Juntendo University
        • Ledende efterforsker:
          • Takehito Shukuya
        • Kontakt:
      • Chuo-ku, Tokyo, Japan, 104-0045
        • Rekruttering
        • National Cancer Center Hospital
        • Ledende efterforsker:
          • Hidehito Horinouchi
        • Kontakt:
  • Polen
      • Poznan, Polen, 60-693
        • Rekruttering
        • Uniwersytecki Szpital Kliniczny
        • Kontakt:
  • Schweiz
      • Baden, Schweiz, 5404
      • Fribourg, Schweiz, 1752
        • Rekruttering
        • HFR Freiburg-Kantonsspital
        • Ledende efterforsker:
          • Alessandra Curioni-Fontecedro
        • Kontakt:
  • Singapore
      • Singapore, Singapore, 329563
        • Rekruttering
        • Curie Oncology
        • Kontakt:
      • Singapore, Singapore, 168583
      • Singapore, Singapore, 574623
        • Rekruttering
        • Icon Cancer Centre Singapore (Singapore Oncology Consultants)
        • Kontakt:
  • Spanien
      • Barcelona, Spanien, 8916
        • Rekruttering
        • Institut Catala d'Oncologia
        • Kontakt:
      • Lleida, Spanien, 25198
        • Rekruttering
        • Hospital Universitario Arnau de Vilanova
        • Kontakt:
      • Madrid, Spanien, 28034
      • Madrid, Spanien, 28027
        • Rekruttering
        • Clinica Universidad de Navarra (Madrid)
        • Kontakt:
          • Miguel Fernandez de Sanmamed Gutierrez
          • Telefonnummer: +34 948255400
          • E-mail: msanmamed@unav.es
      • Málaga, Spanien, 29010
        • Rekruttering
        • Hospital Regional Universitario de Malaga
        • Kontakt:
      • Pamplona, Spanien, 31008
        • Rekruttering
        • Clinica Universidad de Navarra
        • Kontakt:
          • Miguel Fernandez de Sanmamed Gutierrez
          • Telefonnummer: +34 948255400
          • E-mail: msanmamed@unav.es
    • Alicante
      • Elche, Alicante, Spanien, 3293
        • Rekruttering
        • Hospital Universitario del Vinalopo
        • Kontakt:
    • Andalusia
      • Seville, Andalusia, Spanien, 41013
        • Rekruttering
        • Hospital Universitario Virgen del Rocio
        • Kontakt:
    • Catalonia
      • Barcelona, Catalonia, Spanien, 8017
        • Rekruttering
        • Clinica Mi Tres Torres Barcelona - Giromed Institute
        • Kontakt:
    • Madrid
      • Torrejón de Ardoz, Madrid, Spanien, 28850
        • Rekruttering
        • Hospital Universitario de Torrejon
        • Kontakt:
  • Tjekkiet
      • Olomouc, Tjekkiet, 779 00
        • Rekruttering
        • Fakultni nemocnice Olomouc FNOL
        • Kontakt:
      • Ostrava, Tjekkiet, 70300
        • Rekruttering
        • Nemocnice Agel Ostrava-Vitkovice / Agel Ostrava-Vitkovice Hospital
        • Kontakt:
      • Prague, Tjekkiet, 12808
        • Rekruttering
        • General University Hospital in Prague
        • Kontakt:
  • Tyskland
  • Ungarn
      • Farkasgyepű, Ungarn, 8582
        • Rekruttering
        • Farkasgyepui Tudogyogyintezet
        • Kontakt:
      • Kecskemét, Ungarn, 6000
      • Szekszárd, Ungarn, 7100
        • Rekruttering
        • Tolna Varmegyei Balassa Janos Korhaz
        • Kontakt:
  • Østrig
      • Innsbruck, Østrig, 6020
        • Rekruttering
        • Universitaetsklinik fuer Innere Medizin V Innsbruck
        • Kontakt:
      • Salzburg, Østrig, 5020
        • Rekruttering
        • University Hospital Salzburg
        • Kontakt:
      • Vienna, Østrig, 1210
        • Rekruttering
        • Karl Landsteiner Institut fur Lungenforschung und pneumologische Onkologie c/o Klinik Floridsdorf
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: 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.

Medicin: Pembrolizumab

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

Medicin: Platinum based chemotherapy

Platinum-based chemotherapy is a standard chemotherapy regimen commonly used in the treatment of non-small cell lung cancer
Aktiv komparator: Arm 2: Pembrolizumab and Platinum-based Chemotherapy

Subjects in this arm receive two treatments - pembrolizumab and platinum-based chemotherapy.
Medicin: Pembrolizumab

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

Medicin: Platinum based chemotherapy

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival (OS)
Tidsramme: 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).
up to 6 years
Progression Free Survival (PFS)
Tidsramme: 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)
up to 6 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression Free Survival (PFS)
Tidsramme: up to 6 years

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.
up to 6 years
Overall Survival (OS)
Tidsramme: up to 6 years

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.
up to 6 years
Progression Free Survival (PFS)
Tidsramme: up to 6 years

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).
up to 6 years
Overall Survival (OS)
Tidsramme: up to 6 years

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.
up to 6 years
Progression Free Survival (PFS)
Tidsramme: up to 6 years

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.
up to 6 years
1, 2, and 3-year Survival Rate
Tidsramme: up to 6 years

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.
up to 6 years
Objective Response Rate (ORR)
Tidsramme: up to 6 years

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.
up to 6 years
Duration of Response (DoR)
Tidsramme: up to 6 years

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.
up to 6 years
Disease Control Rate (DCR)
Tidsramme: up to 6 years

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.
up to 6 years
Progression Free Survival (PFS)
Tidsramme: up to 6 years

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.
up to 6 years
Objective Response Rate (ORR)
Tidsramme: up to 6 years

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.
up to 6 years
Duration of Response (DoR)
Tidsramme: up to 6 years

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.
up to 6 years
Disease Control Rate (DCR)
Tidsramme: up to 6 years

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.
up to 6 years
Adverse Events
Tidsramme: up to 6 years

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.
up to 6 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

NovoCure GmbH

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

31. juli 2024

Primær færdiggørelse (Anslået)

1. oktober 2028

Studieafslutning (Anslået)

1. oktober 2028

Datoer for studieregistrering

Først indsendt

29. december 2023

Først indsendt, der opfyldte QC-kriterier

10. januar 2024

Først opslået (Faktiske)

22. januar 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. oktober 2026

Sidst verificeret

1. december 2025

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • EF-44

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

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