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LUNAR-2: TTFields con pembrolizumab + chemioterapia a base di platino per NSCLC metastatico (LUNAR-2)

5 novembre 2026 aggiornato da: NovoCure GmbH

LUNAR-2: studio cardine, randomizzato, in aperto sui campi di trattamento dei tumori (TTFields, 150 kHz) in concomitanza con pembrolizumab e chemioterapia a base di platino per il trattamento del cancro polmonare metastatico non a piccole cellule

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

734

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Dispositivo: 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.

Droga: Pembrolizumab

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

Droga: Platinum based chemotherapy

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

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

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

Droga: Platinum based chemotherapy

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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Survival (OS)
Lasso di tempo: 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)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression Free Survival (PFS)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

NovoCure GmbH

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

31 luglio 2024

Completamento primario (Stimato)

1 ottobre 2028

Completamento dello studio (Stimato)

1 ottobre 2028

Date di iscrizione allo studio

Primo inviato

29 dicembre 2023

Primo inviato che soddisfa i criteri di controllo qualità

10 gennaio 2024

Primo Inserito (Effettivo)

22 gennaio 2024

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 novembre 2026

Ultimo verificato

1 dicembre 2025

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • EF-44

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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