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LUNAR-2 : TTFields avec pembrolizumab + chimiothérapie à base de platine pour le CPNPC métastatique (LUNAR-2)

5 novembre 2026 mis à jour par: NovoCure GmbH

LUNAR-2 : étude pivot, randomisée et ouverte sur les champs de traitement des tumeurs (TTFields, 150 kHz) en association avec le pembrolizumab et la chimiothérapie à base de platine pour le traitement du cancer du poumon non à petites cellules métastatique

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

734

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Allemagne
      • Berlin, Allemagne, 13125
        • Recrutement
        • Evangelische Lungenklinik Berlin
        • Contact:
      • Giessen, Allemagne, 35392
      • Halle, Allemagne, 06120
        • Recrutement
        • Krankenhaus Martha-Maria Halle-Dolau
        • Chercheur principal:
          • Wolfgang Schuette
        • Contact:
      • Heidelberg, Allemagne, 69126
      • Löwenstein, Allemagne, 74245
      • Oldenburg, Allemagne, 26121
  • Belgique
      • Brussels, Belgique, 1200
        • Recrutement
        • Cliniques universitaires Saint-Luc
        • Contact:
      • Ghent, Belgique, 9000
        • Recrutement
        • AZ Maria Middelares - Campus Maria Middelares
        • Contact:
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Recrutement
        • Cross Cancer Institute/University of Alberta
        • Contact:
        • Chercheur principal:
          • Haidar El Darsa
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recrutement
        • The Ottawa Hospital Cancer Centre General Campus
        • Chercheur principal:
          • Garth Nicholas
        • Contact:
          • Garth Nicholas
          • Numéro de téléphone: 70175 613-737-7700
          • E-mail: gnicholas@toh.ca
      • Toronto, Ontario, Canada, M4N 3M5
        • Recrutement
        • Sunnybrook Health Sciences Center
        • Contact:
        • Chercheur principal:
          • Susanna Cheng
    • Quebec
      • Montreal, Quebec, Canada, H2L 4M1
        • Recrutement
        • CHUM
        • Chercheur principal:
          • David Roberge
        • Contact:
  • Espagne
      • Barcelona, Espagne, 8916
        • Recrutement
        • Institut Catala d'Oncologia
        • Contact:
      • Lleida, Espagne, 25198
        • Recrutement
        • Hospital Universitario Arnau de Vilanova
        • Contact:
      • Madrid, Espagne, 28034
      • Madrid, Espagne, 28027
        • Recrutement
        • Clinica Universidad de Navarra (Madrid)
        • Contact:
          • Miguel Fernandez de Sanmamed Gutierrez
          • Numéro de téléphone: +34 948255400
          • E-mail: msanmamed@unav.es
      • Málaga, Espagne, 29010
        • Recrutement
        • Hospital Regional Universitario de Malaga
        • Contact:
      • Pamplona, Espagne, 31008
        • Recrutement
        • Clinica Universidad de Navarra
        • Contact:
          • Miguel Fernandez de Sanmamed Gutierrez
          • Numéro de téléphone: +34 948255400
          • E-mail: msanmamed@unav.es
    • Alicante
      • Elche, Alicante, Espagne, 3293
        • Recrutement
        • Hospital Universitario del Vinalopo
        • Contact:
    • Andalusia
      • Seville, Andalusia, Espagne, 41013
        • Recrutement
        • Hospital Universitario Virgen del Rocio
        • Contact:
          • Carlos Cabrera
          • Numéro de téléphone: +34 932 287 445
          • E-mail: ccabrera@uomi.es
    • Catalonia
      • Barcelona, Catalonia, Espagne, 8017
        • Recrutement
        • Clinica Mi Tres Torres Barcelona - Giromed Institute
        • Contact:
          • Carlos Cabrera Galvez
          • Numéro de téléphone: +34 932 287 445
          • E-mail: ccabrera@uomi.es
    • Madrid
      • Torrejón de Ardoz, Madrid, Espagne, 28850
        • Recrutement
        • Hospital Universitario de Torrejon
        • Contact:
  • France
      • Créteil, France, 94010
        • Recrutement
        • Centre Hospitalier Intercommunal de Creteil
        • Contact:
      • Limoges, France, 87000
        • Recrutement
        • CHU Limoges
        • Chercheur principal:
          • Thomas Egenod
        • Contact:
      • Marseille, France, 13003
      • Nantes, France, 44277
        • Recrutement
        • Hopital Prive du Confluent
        • Chercheur principal:
          • Cyriac Blonz
        • Contact:
      • Paris, France, 75005
        • Recrutement
        • Institut Curie
        • Contact:
      • Pessac, France, 33604
      • Pierre-Bénite, France, 69495
        • Recrutement
        • Centre Hospitalier Lyon Sud
        • Contact:
      • Strasbourg, France, 67091
  • Hongrie
      • Farkasgyepű, Hongrie, 8582
        • Recrutement
        • Farkasgyepui Tudogyogyintezet
        • Contact:
      • Kecskemét, Hongrie, 6000
      • Szekszárd, Hongrie, 7100
        • Recrutement
        • Tolna Varmegyei Balassa Janos Korhaz
        • Contact:
  • Israël
      • Afula, Israël, 1834111
        • Recrutement
        • Emek Medical Center
        • Contact:
      • Haifa, Israël, 34561
  • Italie
      • Alessandria, Italie, 15121
      • Bergamo, Italie, 24125
      • Ferrara, Italie, 44124
        • Recrutement
        • Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna
        • Contact:
      • Meldola, Italie, 47014
        • Recrutement
        • IRCCS - Istituto Romagnolo per lo Studio Dei Tumori, Dino Amadori
        • Contact:
      • Pesaro, Italie, 61122
        • Recrutement
        • Azienda Sanitaria Territoriale Pesaro Urbino
        • Contact:
      • Roma, Italie, 00128
        • Recrutement
        • Universita Campus Bio-Medico di Roma (UCBM) - Policlinico Universitario
        • Contact:
      • Rome, Italie, 00186
      • Siena, Italie, 53100
        • Recrutement
        • Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
        • Contact:
          • Michele Maio
          • Numéro de téléphone: 00390577586336
          • E-mail: maio@unisi.it
  • Japon
    • Osaka
      • Osaka, Osaka, Japon, 541-8567
        • Recrutement
        • Osaka International Cancer Institute
        • Contact:
        • Chercheur principal:
          • Kei Kunimasa
      • Sakai, Osaka, Japon, 590-0197
        • Recrutement
        • Kindai University Hospital
        • Chercheur principal:
          • Hidetoshi Hayashi
        • Contact:
    • Saitama
      • Hidaka, Saitama, Japon, 350-1298
        • Recrutement
        • Saitama Medical University International Medical Center
        • Contact:
    • Tokyo
      • Bunkyo, Tokyo, Japon, 113-8431
        • Recrutement
        • Juntendo University
        • Chercheur principal:
          • Takehito Shukuya
        • Contact:
      • Chuo-ku, Tokyo, Japon, 104-0045
        • Recrutement
        • National Cancer Center Hospital
        • Chercheur principal:
          • Hidehito Horinouchi
        • Contact:
  • L'Autriche
      • Innsbruck, L'Autriche, 6020
        • Recrutement
        • Universitaetsklinik fuer Innere Medizin V Innsbruck
        • Contact:
      • Salzburg, L'Autriche, 5020
        • Recrutement
        • University Hospital Salzburg
        • Contact:
          • Richard Greil
          • Numéro de téléphone: 43-662-4482 4100
          • E-mail: r.greil@salk.at
      • Vienna, L'Autriche, 1210
        • Recrutement
        • Karl Landsteiner Institut fur Lungenforschung und pneumologische Onkologie c/o Klinik Floridsdorf
        • Contact:
  • Pays-Bas
      • Arnhem, Pays-Bas, 6815AD
        • Recrutement
        • Rijnstate Ziekenhuis
        • Contact:
      • Friesland, Pays-Bas, 8934 AD
        • Recrutement
        • Medisch Centrum Leeuwarden (MCL) - Oncologisch Centrum Leeuwarden (OCL)
        • Contact:
      • Harderwijk, Pays-Bas, 3844 DG
      • Utrecht, Pays-Bas, 3543 AZ
  • Pologne
      • Poznan, Pologne, 60-693
        • Recrutement
        • Uniwersytecki Szpital Kliniczny
        • Contact:
  • Royaume-Uni
    • Greater London
      • London, Greater London, Royaume-Uni
        • Recrutement
        • Charing Cross Hospital
        • Contact:
        • Chercheur principal:
          • Waleed Mohammed
    • Leicestershire
      • Leicester, Leicestershire, Royaume-Uni, LE1 5WW
        • Recrutement
        • University Hospitals of Leicester NHS Trust
        • Contact:
        • Chercheur principal:
          • Sean Dulloo
    • London
      • London, London, Royaume-Uni, SW3 6JJ
        • Recrutement
        • The Royal Marsden NHS Foundation Trust
        • Contact:
    • Merseyside
      • Liverpool, Merseyside, Royaume-Uni, L7 8YA
        • Recrutement
        • Clatterbridge Cancer Centre - Liverpool
        • Chercheur principal:
          • Carles Escriu
        • Contact:
    • Sutton
      • Sutton, Sutton, Royaume-Uni, SM2 5PT
        • Recrutement
        • The Royal Marsden NHS Foundation Trust - Sutton
        • Contact:
  • Singapour
      • Singapore, Singapour, 329563
        • Recrutement
        • Curie Oncology
        • Contact:
      • Singapore, Singapour, 168583
      • Singapore, Singapour, 574623
        • Recrutement
        • Icon Cancer Centre Singapore (Singapore Oncology Consultants)
        • Contact:
  • Suisse
      • Baden, Suisse, 5404
      • Fribourg, Suisse, 1752
        • Recrutement
        • HFR Freiburg-Kantonsspital
        • Chercheur principal:
          • Alessandra Curioni-Fontecedro
        • Contact:
  • Tchéquie
      • Olomouc, Tchéquie, 779 00
        • Recrutement
        • Fakultni nemocnice Olomouc FNOL
        • Contact:
      • Ostrava, Tchéquie, 70300
        • Recrutement
        • Nemocnice Agel Ostrava-Vitkovice / Agel Ostrava-Vitkovice Hospital
        • Contact:
      • Prague, Tchéquie, 12808
        • Recrutement
        • General University Hospital in Prague
        • Contact:
  • États-Unis
    • Alabama
      • Birmingham, Alabama, États-Unis, 35209
    • Arizona
      • Goodyear, Arizona, États-Unis, 85338
        • Recrutement
        • Western Regional Medical Center, LLC
        • Contact:
    • California
      • Fullerton, California, États-Unis, 92835
      • Newport Beach, California, États-Unis, 92663
        • Recrutement
        • Hoag Family Cancer Institute - Hoag Memorial Hospital
        • Contact:
      • Sacramento, California, États-Unis, 95816
        • Recrutement
        • Sutter Institute for Medical Research
        • Contact:
    • Florida
      • Jacksonville, Florida, États-Unis, 32207
        • Recrutement
        • Baptist MD Anderson Cancer Center, Baptist Health
        • Contact:
        • Chercheur principal:
          • John Vu
      • Ocala, Florida, États-Unis, 34474
        • Recrutement
        • Florida Cancer Affiliates - Ocala Oncology
        • Contact:
      • Tampa, Florida, États-Unis, 33612
        • Recrutement
        • Moffitt Cancer Center
        • Contact:
    • Illinois
      • Barrington, Illinois, États-Unis, 60010
        • Recrutement
        • Northwest Oncology & Hematology
        • Contact:
      • Elmhurst, Illinois, États-Unis, 60126
        • Recrutement
        • Elmhurst Hospital Nancy Knowles Cancer Center
        • Contact:
      • Naperville, Illinois, États-Unis, 60540-6766
      • Zion, Illinois, États-Unis, 60099
        • Recrutement
        • Cancer Treatment Centers of America (CTCA)
        • Contact:
    • Indiana
      • Fort Wayne, Indiana, États-Unis, 46845
        • Recrutement
        • Parkview Packnett Family Cancer Institute
        • Chercheur principal:
          • Brian Chang
        • Contact:
      • Indianapolis, Indiana, États-Unis, 46237
    • Kansas
      • Westwood, Kansas, États-Unis, 66205
        • Recrutement
        • University of Kansas Cancer Center
        • Contact:
    • Missouri
      • Annapolis, Missouri, États-Unis, 21401
        • Recrutement
        • Luminis Health Radiation Oncology - Anne Arundel Health System
        • Contact:
      • Kansas City, Missouri, États-Unis, 64154
        • Recrutement
        • University of Kansas Cancer Center - North
        • Contact:
      • Lee's Summit, Missouri, États-Unis, 64064
        • Recrutement
        • University of Kansas Cancer Center - Lee's Summit
        • Contact:
      • Overland, Missouri, États-Unis, 66210
        • Recrutement
        • University of Kansas Cancer Center - Overland Park
        • Contact:
    • New York
      • New Hyde Park, New York, États-Unis, 11042
        • Recrutement
        • New York Cancer & Blood Specialists (NYCBS)
        • Contact:
      • New York, New York, États-Unis, 10028
        • Recrutement
        • New York Cancer & Blood Specialists (NYCBS)
        • Contact:
      • Rochester, New York, États-Unis, 14642
      • Shirley, New York, États-Unis, 19967
        • Recrutement
        • New York Cancer & Blood Specialists (NYCBS)
        • Contact:
      • The Bronx, New York, États-Unis, 10469
        • Recrutement
        • New York Cancer & Blood Specialists (NYCBS)
        • Contact:
    • North Carolina
      • Cary, North Carolina, États-Unis, 27518
        • Recrutement
        • WakeMed Health & Hospitals
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, États-Unis, 19104
      • Pittsburgh, Pennsylvania, États-Unis, 15212
        • Recrutement
        • AHN Cancer Center
        • Contact:
    • Texas
      • Dallas, Texas, États-Unis, 75235
      • Dallas, Texas, États-Unis, 75235
        • Recrutement
        • Old Parkland Hospital Hematology Oncology Clinic
        • Contact:
      • Edinburg, Texas, États-Unis, 78539
        • Recrutement
        • DHR Health Oncology Institute
        • Contact:
      • Houston, Texas, États-Unis, 77030
        • Recrutement
        • Houston Methodist Cancer Center
        • Chercheur principal:
          • Jun Zhang
        • Contact:
      • Richardson, Texas, États-Unis, 75082
        • Recrutement
        • Methodist Richardson Cancer Center
        • Contact:
      • San Antonio, Texas, États-Unis, 78229
        • Recrutement
        • Jason Bates at University of Texas Health Science Center
        • Contact:
    • Washington
      • Auburn, Washington, États-Unis, 98001
        • Recrutement
        • MultiCare Regional Cancer Center
        • Contact:
      • Gig Harbor, Washington, États-Unis, 98335
        • Recrutement
        • MultiCare Regional Cancer Center
        • Contact:
      • Puyallup, Washington, États-Unis, 98372
        • Recrutement
        • MultiCare Regional Cancer Center
        • Contact:
      • Spokane, Washington, États-Unis, 99218
        • Recrutement
        • MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
        • Contact:
      • Tacoma, Washington, États-Unis, 98405
        • Recrutement
        • MultiCare Institute for Research & Innovation
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Dispositif: 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.

Médicament: Pembrolizumab

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

Médicament: Platinum based chemotherapy

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

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

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

Médicament: Platinum based chemotherapy

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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Overall Survival (OS)
Délai: 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)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Progression Free Survival (PFS)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

NovoCure GmbH

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

31 juillet 2024

Achèvement primaire (Estimé)

1 octobre 2028

Achèvement de l'étude (Estimé)

1 octobre 2028

Dates d'inscription aux études

Première soumission

29 décembre 2023

Première soumission répondant aux critères de contrôle qualité

10 janvier 2024

Première publication (Réel)

22 janvier 2024

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

10 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 novembre 2026

Dernière vérification

1 décembre 2025

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • EF-44

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Oui

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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