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LUNAR-2: TTFields mit Pembrolizumab + platinbasierter Chemotherapie bei metastasiertem NSCLC (LUNAR-2)

5. November 2026 aktualisiert von: NovoCure GmbH

LUNAR-2: Pivotale, randomisierte, offene Studie zu Tumorbehandlungsfeldern (TTFields, 150 kHz) in Kombination mit Pembrolizumab und platinbasierter Chemotherapie zur Behandlung von metastasiertem nicht-kleinzelligem Lungenkrebs

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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

734

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Belgien
      • Brussels, Belgien, 1200
        • Rekrutierung
        • Cliniques universitaires Saint-Luc
        • Kontakt:
      • Ghent, Belgien, 9000
  • Deutschland
  • Frankreich
      • Créteil, Frankreich, 94010
        • Rekrutierung
        • Centre Hospitalier Intercommunal de Creteil
        • Kontakt:
      • Limoges, Frankreich, 87000
        • Rekrutierung
        • CHU Limoges
        • Hauptermittler:
          • Thomas Egenod
        • Kontakt:
      • Marseille, Frankreich, 13003
      • Nantes, Frankreich, 44277
        • Rekrutierung
        • Hopital Prive du Confluent
        • Hauptermittler:
          • Cyriac Blonz
        • Kontakt:
      • Paris, Frankreich, 75005
      • Pessac, Frankreich, 33604
      • Pierre-Bénite, Frankreich, 69495
      • Strasbourg, Frankreich, 67091
  • Israel
      • Afula, Israel, 1834111
        • Rekrutierung
        • Emek Medical Center
        • Kontakt:
      • Haifa, Israel, 34561
  • Italien
      • Alessandria, Italien, 15121
      • Bergamo, Italien, 24125
      • Ferrara, Italien, 44124
        • Rekrutierung
        • Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna
        • Kontakt:
      • Meldola, Italien, 47014
        • Rekrutierung
        • IRCCS - Istituto Romagnolo per lo Studio Dei Tumori, Dino Amadori
        • Kontakt:
      • Pesaro, Italien, 61122
        • Rekrutierung
        • Azienda Sanitaria Territoriale Pesaro Urbino
        • Kontakt:
      • Roma, Italien, 00128
        • Rekrutierung
        • Universita Campus Bio-Medico di Roma (UCBM) - Policlinico Universitario
        • Kontakt:
      • Rome, Italien, 00186
      • Siena, Italien, 53100
        • Rekrutierung
        • Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
        • Kontakt:
          • Michele Maio
          • Telefonnummer: 00390577586336
          • E-Mail: maio@unisi.it
  • Japan
    • Osaka
      • Osaka, Osaka, Japan, 541-8567
        • Rekrutierung
        • Osaka International Cancer Institute
        • Kontakt:
        • Hauptermittler:
          • Kei Kunimasa
      • Sakai, Osaka, Japan, 590-0197
        • Rekrutierung
        • Kindai University Hospital
        • Hauptermittler:
          • Hidetoshi Hayashi
        • Kontakt:
    • Saitama
      • Hidaka, Saitama, Japan, 350-1298
        • Rekrutierung
        • Saitama Medical University International Medical Center
        • Kontakt:
    • Tokyo
      • Bunkyo, Tokyo, Japan, 113-8431
        • Rekrutierung
        • Juntendo University
        • Hauptermittler:
          • Takehito Shukuya
        • Kontakt:
      • Chuo-ku, Tokyo, Japan, 104-0045
        • Rekrutierung
        • National Cancer Center Hospital
        • Hauptermittler:
          • Hidehito Horinouchi
        • Kontakt:
  • Kanada
    • Alberta
      • Edmonton, Alberta, Kanada, T6G 1Z2
        • Rekrutierung
        • Cross Cancer Institute/University of Alberta
        • Kontakt:
        • Hauptermittler:
          • Haidar El Darsa
    • Ontario
      • Ottawa, Ontario, Kanada, K1H 8L6
        • Rekrutierung
        • The Ottawa Hospital Cancer Centre General Campus
        • Hauptermittler:
          • Garth Nicholas
        • Kontakt:
      • Toronto, Ontario, Kanada, M4N 3M5
        • Rekrutierung
        • Sunnybrook Health Sciences Center
        • Kontakt:
        • Hauptermittler:
          • Susanna Cheng
    • Quebec
      • Montreal, Quebec, Kanada, H2L 4M1
  • Niederlande
      • Arnhem, Niederlande, 6815AD
        • Rekrutierung
        • Rijnstate Ziekenhuis
        • Kontakt:
      • Friesland, Niederlande, 8934 AD
        • Rekrutierung
        • Medisch Centrum Leeuwarden (MCL) - Oncologisch Centrum Leeuwarden (OCL)
        • Kontakt:
      • Harderwijk, Niederlande, 3844 DG
      • Utrecht, Niederlande, 3543 AZ
  • Polen
      • Poznan, Polen, 60-693
        • Rekrutierung
        • Uniwersytecki Szpital Kliniczny
        • Kontakt:
  • Schweiz
      • Baden, Schweiz, 5404
      • Fribourg, Schweiz, 1752
        • Rekrutierung
        • HFR Freiburg-Kantonsspital
        • Hauptermittler:
          • Alessandra Curioni-Fontecedro
        • Kontakt:
  • Singapur
      • Singapore, Singapur, 329563
        • Rekrutierung
        • Curie Oncology
        • Kontakt:
      • Singapore, Singapur, 168583
      • Singapore, Singapur, 574623
        • Rekrutierung
        • Icon Cancer Centre Singapore (Singapore Oncology Consultants)
        • Kontakt:
  • Spanien
      • Barcelona, Spanien, 8916
        • Rekrutierung
        • Institut Catala d'Oncologia
        • Kontakt:
      • Lleida, Spanien, 25198
        • Rekrutierung
        • Hospital Universitario Arnau de Vilanova
        • Kontakt:
      • Madrid, Spanien, 28034
      • Madrid, Spanien, 28027
        • Rekrutierung
        • Clinica Universidad de Navarra (Madrid)
        • Kontakt:
          • Miguel Fernandez de Sanmamed Gutierrez
          • Telefonnummer: +34 948255400
          • E-Mail: msanmamed@unav.es
      • Málaga, Spanien, 29010
        • Rekrutierung
        • Hospital Regional Universitario de Malaga
        • Kontakt:
      • Pamplona, Spanien, 31008
        • Rekrutierung
        • Clinica Universidad de Navarra
        • Kontakt:
          • Miguel Fernandez de Sanmamed Gutierrez
          • Telefonnummer: +34 948255400
          • E-Mail: msanmamed@unav.es
    • Alicante
      • Elche, Alicante, Spanien, 3293
        • Rekrutierung
        • Hospital Universitario del Vinalopo
        • Kontakt:
    • Andalusia
      • Seville, Andalusia, Spanien, 41013
        • Rekrutierung
        • Hospital Universitario Virgen del Rocio
        • Kontakt:
    • Catalonia
      • Barcelona, Catalonia, Spanien, 8017
        • Rekrutierung
        • Clinica Mi Tres Torres Barcelona - Giromed Institute
        • Kontakt:
    • Madrid
      • Torrejón de Ardoz, Madrid, Spanien, 28850
        • Rekrutierung
        • Hospital Universitario de Torrejon
        • Kontakt:
  • Tschechien
      • Olomouc, Tschechien, 779 00
        • Rekrutierung
        • Fakultni nemocnice Olomouc FNOL
        • Kontakt:
      • Ostrava, Tschechien, 70300
        • Rekrutierung
        • Nemocnice Agel Ostrava-Vitkovice / Agel Ostrava-Vitkovice Hospital
        • Kontakt:
      • Prague, Tschechien, 12808
        • Rekrutierung
        • General University Hospital in Prague
        • Kontakt:
  • Ungarn
      • Farkasgyepű, Ungarn, 8582
        • Rekrutierung
        • Farkasgyepui Tudogyogyintezet
        • Kontakt:
      • Kecskemét, Ungarn, 6000
      • Szekszárd, Ungarn, 7100
        • Rekrutierung
        • Tolna Varmegyei Balassa Janos Korhaz
        • Kontakt:
  • Vereinigte Staaten
    • Alabama
      • Birmingham, Alabama, Vereinigte Staaten, 35209
    • Arizona
      • Goodyear, Arizona, Vereinigte Staaten, 85338
        • Rekrutierung
        • Western Regional Medical Center, LLC
        • Kontakt:
    • California
      • Fullerton, California, Vereinigte Staaten, 92835
      • Newport Beach, California, Vereinigte Staaten, 92663
        • Rekrutierung
        • Hoag Family Cancer Institute - Hoag Memorial Hospital
        • Kontakt:
      • Sacramento, California, Vereinigte Staaten, 95816
        • Rekrutierung
        • Sutter Institute for Medical Research
        • Kontakt:
    • Florida
      • Jacksonville, Florida, Vereinigte Staaten, 32207
        • Rekrutierung
        • Baptist MD Anderson Cancer Center, Baptist Health
        • Kontakt:
        • Hauptermittler:
          • John Vu
      • Ocala, Florida, Vereinigte Staaten, 34474
        • Rekrutierung
        • Florida Cancer Affiliates - Ocala Oncology
        • Kontakt:
      • Tampa, Florida, Vereinigte Staaten, 33612
    • Illinois
      • Barrington, Illinois, Vereinigte Staaten, 60010
      • Elmhurst, Illinois, Vereinigte Staaten, 60126
        • Rekrutierung
        • Elmhurst Hospital Nancy Knowles Cancer Center
        • Kontakt:
      • Naperville, Illinois, Vereinigte Staaten, 60540-6766
      • Zion, Illinois, Vereinigte Staaten, 60099
        • Rekrutierung
        • Cancer Treatment Centers of America (CTCA)
        • Kontakt:
    • Indiana
      • Fort Wayne, Indiana, Vereinigte Staaten, 46845
        • Rekrutierung
        • Parkview Packnett Family Cancer Institute
        • Hauptermittler:
          • Brian Chang
        • Kontakt:
      • Indianapolis, Indiana, Vereinigte Staaten, 46237
    • Kansas
      • Westwood, Kansas, Vereinigte Staaten, 66205
        • Rekrutierung
        • University of Kansas Cancer Center
        • Kontakt:
    • Missouri
      • Annapolis, Missouri, Vereinigte Staaten, 21401
        • Rekrutierung
        • Luminis Health Radiation Oncology - Anne Arundel Health System
        • Kontakt:
      • Kansas City, Missouri, Vereinigte Staaten, 64154
        • Rekrutierung
        • University of Kansas Cancer Center - North
        • Kontakt:
      • Lee's Summit, Missouri, Vereinigte Staaten, 64064
        • Rekrutierung
        • University of Kansas Cancer Center - Lee's Summit
        • Kontakt:
      • Overland, Missouri, Vereinigte Staaten, 66210
        • Rekrutierung
        • University of Kansas Cancer Center - Overland Park
        • Kontakt:
    • New York
      • New Hyde Park, New York, Vereinigte Staaten, 11042
        • Rekrutierung
        • New York Cancer & Blood Specialists (NYCBS)
        • Kontakt:
      • New York, New York, Vereinigte Staaten, 10028
        • Rekrutierung
        • New York Cancer & Blood Specialists (NYCBS)
        • Kontakt:
      • Rochester, New York, Vereinigte Staaten, 14642
      • Shirley, New York, Vereinigte Staaten, 19967
        • Rekrutierung
        • New York Cancer & Blood Specialists (NYCBS)
        • Kontakt:
      • The Bronx, New York, Vereinigte Staaten, 10469
        • Rekrutierung
        • New York Cancer & Blood Specialists (NYCBS)
        • Kontakt:
    • North Carolina
      • Cary, North Carolina, Vereinigte Staaten, 27518
        • Rekrutierung
        • WakeMed Health & Hospitals
        • Kontakt:
    • Pennsylvania
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
      • Pittsburgh, Pennsylvania, Vereinigte Staaten, 15212
        • Rekrutierung
        • AHN Cancer Center
        • Kontakt:
    • Texas
      • Dallas, Texas, Vereinigte Staaten, 75235
      • Dallas, Texas, Vereinigte Staaten, 75235
      • Edinburg, Texas, Vereinigte Staaten, 78539
        • Rekrutierung
        • DHR Health Oncology Institute
        • Kontakt:
      • Houston, Texas, Vereinigte Staaten, 77030
        • Rekrutierung
        • Houston Methodist Cancer Center
        • Hauptermittler:
          • Jun Zhang
        • Kontakt:
      • Richardson, Texas, Vereinigte Staaten, 75082
        • Rekrutierung
        • Methodist Richardson Cancer Center
        • Kontakt:
      • San Antonio, Texas, Vereinigte Staaten, 78229
        • Rekrutierung
        • Jason Bates at University of Texas Health Science Center
        • Kontakt:
    • Washington
      • Auburn, Washington, Vereinigte Staaten, 98001
        • Rekrutierung
        • MultiCare Regional Cancer Center
        • Kontakt:
      • Gig Harbor, Washington, Vereinigte Staaten, 98335
        • Rekrutierung
        • MultiCare Regional Cancer Center
        • Kontakt:
      • Puyallup, Washington, Vereinigte Staaten, 98372
        • Rekrutierung
        • MultiCare Regional Cancer Center
        • Kontakt:
      • Spokane, Washington, Vereinigte Staaten, 99218
        • Rekrutierung
        • MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
        • Kontakt:
      • Tacoma, Washington, Vereinigte Staaten, 98405
        • Rekrutierung
        • MultiCare Institute for Research & Innovation
        • Kontakt:
  • Vereinigtes Königreich
    • Greater London
      • London, Greater London, Vereinigtes Königreich
        • Rekrutierung
        • Charing Cross Hospital
        • Kontakt:
        • Hauptermittler:
          • Waleed Mohammed
    • Leicestershire
      • Leicester, Leicestershire, Vereinigtes Königreich, LE1 5WW
        • Rekrutierung
        • University Hospitals of Leicester NHS Trust
        • Kontakt:
        • Hauptermittler:
          • Sean Dulloo
    • London
      • London, London, Vereinigtes Königreich, SW3 6JJ
        • Rekrutierung
        • The Royal Marsden NHS Foundation Trust
        • Kontakt:
    • Merseyside
      • Liverpool, Merseyside, Vereinigtes Königreich, L7 8YA
        • Rekrutierung
        • Clatterbridge Cancer Centre - Liverpool
        • Hauptermittler:
          • Carles Escriu
        • Kontakt:
    • Sutton
      • Sutton, Sutton, Vereinigtes Königreich, SM2 5PT
        • Rekrutierung
        • The Royal Marsden NHS Foundation Trust - Sutton
        • Kontakt:
  • Österreich
      • Innsbruck, Österreich, 6020
        • Rekrutierung
        • Universitaetsklinik fuer Innere Medizin V Innsbruck
        • Kontakt:
      • Salzburg, Österreich, 5020
        • Rekrutierung
        • University Hospital Salzburg
        • Kontakt:
      • Vienna, Österreich, 1210
        • Rekrutierung
        • Karl Landsteiner Institut fur Lungenforschung und pneumologische Onkologie c/o Klinik Floridsdorf
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Gerät: 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.

Arzneimittel: Pembrolizumab

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

Arzneimittel: Platinum based chemotherapy

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

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

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

Arzneimittel: Platinum based chemotherapy

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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Overall Survival (OS)
Zeitfenster: 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)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Progression Free Survival (PFS)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

NovoCure GmbH

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

31. Juli 2024

Primärer Abschluss (Geschätzt)

1. Oktober 2028

Studienabschluss (Geschätzt)

1. Oktober 2028

Studienanmeldedaten

Zuerst eingereicht

29. Dezember 2023

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

10. Januar 2024

Zuerst gepostet (Tatsächlich)

22. Januar 2024

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

5. November 2026

Zuletzt verifiziert

1. Dezember 2025

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • EF-44

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Ja

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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