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LUNAR-2: TTFields met Pembrolizumab + op platina gebaseerde chemotherapie voor gemetastaseerd NSCLC (LUNAR-2)

1 oktober 2026 bijgewerkt door: NovoCure GmbH

LUNAR-2: Cruciale, gerandomiseerde, open-label studie van tumorbehandelende velden (TTFields, 150 kHz) gelijktijdig met pembrolizumab en op platina gebaseerde chemotherapie voor de behandeling van gemetastaseerde niet-kleincellige longkanker

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

734

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Apparaat: 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.

Geneesmiddel: Pembrolizumab

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

Geneesmiddel: Platinum based chemotherapy

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

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

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

Geneesmiddel: Platinum based chemotherapy

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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overall Survival (OS)
Tijdsspanne: 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)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Progression Free Survival (PFS)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

NovoCure GmbH

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

31 juli 2024

Primaire voltooiing (Geschat)

1 oktober 2028

Studie voltooiing (Geschat)

1 oktober 2028

Studieregistratiedata

Eerst ingediend

29 december 2023

Eerst ingediend dat voldeed aan de QC-criteria

10 januari 2024

Eerst geplaatst (Werkelijk)

22 januari 2024

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

1 oktober 2026

Laatst geverifieerd

1 december 2025

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • EF-44

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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