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LUNAR-2: TTFields com pembrolizumabe + quimioterapia à base de platina para NSCLC metastático (LUNAR-2)

5 de novembro de 2026 atualizado por: NovoCure GmbH

LUNAR-2: estudo principal, randomizado e aberto de campos de tratamento de tumores (TTFields, 150 kHz) concomitante com pembrolizumabe e quimioterapia à base de platina para o tratamento de câncer de pulmão metastático de células não pequenas

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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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 de estudo

Intervencional

Inscrição (Estimado)

734

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
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.

Medicamento: Pembrolizumab

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

Medicamento: Platinum based chemotherapy

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

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

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

Medicamento: Platinum based chemotherapy

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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Overall Survival (OS)
Prazo: 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)
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Progression Free Survival (PFS)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

NovoCure GmbH

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

31 de julho de 2024

Conclusão Primária (Estimado)

1 de outubro de 2028

Conclusão do estudo (Estimado)

1 de outubro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

29 de dezembro de 2023

Enviado pela primeira vez que atendeu aos critérios de CQ

10 de janeiro de 2024

Primeira postagem (Real)

22 de janeiro de 2024

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

5 de novembro de 2026

Última verificação

1 de dezembro de 2025

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • EF-44

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Sim

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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