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LUNAR-2：TTFields 联合 Pembrolizumab + 铂类化疗治疗转移性非小细胞肺癌 (LUNAR-2)

2026年11月5日 更新者：NovoCure GmbH

LUNAR-2：肿瘤治疗场（TTFields，150 kHz）联合派姆单抗和铂类化疗治疗转移性非小细胞肺癌的关键、随机、开放标签研究

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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

734

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
设备：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.

药品：Pembrolizumab

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

药品：Platinum based chemotherapy

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

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

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

药品：Platinum based chemotherapy

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

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Overall Survival (OS)
大体时间：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)
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Progression Free Survival (PFS)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

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NovoCure GmbH

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年7月31日

初级完成 (估计的)

2028年10月1日

研究完成 (估计的)

2028年10月1日

研究注册日期

首次提交

2023年12月29日

首先提交符合 QC 标准的

2024年1月10日

首次发布 (实际的)

2024年1月22日

研究记录更新

最后更新发布 (实际的)

2026年11月10日

上次提交的符合 QC 标准的更新

2026年11月5日

最后验证

2025年12月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • EF-44

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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