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Electric field therapy device takes on metastatic lung cancer in major trial

NCT ID NCT06216301

Disease control Sponsor: NovoCure GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial tests whether adding a wearable device that delivers electric fields (TTFields) to standard immunotherapy and chemotherapy improves survival in people with metastatic non-small cell lung cancer. About 734 participants who have not had prior treatment for their advanced cancer will be enrolled. The device is used at home and aims to disrupt cancer cell division.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tumor Treating Fields (TTFields) delivered by a portable device, plus pembrolizumab and platinum-based chemotherapy
What this could lead to
If successful, this could provide a new treatment option that extends survival for people with advanced lung cancer by adding TTFields to standard immunotherapy and chemotherapy.
What could go wrong
This is a Phase 3 trial, but results are not yet known. Adding a device may increase side effects or burden without clear benefit. The study is large but still experimental.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 734 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Neoplasm Metastasis non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic non-small cell lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    98 sites in 16 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • A.O. SS. Antonio e Biagio e Cesare Arrigo di Alessandria

    RECRUITING

    Alessandria, 15121, Italy

  • AHN Cancer Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15212, United States

    Contact Email: •••••@•••••

  • AZ Maria Middelares - Campus Maria Middelares

    RECRUITING

    Ghent, 9000, Belgium

  • Abramson Cancer Center

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte

    RECRUITING

    Siena, 53100, Italy

  • Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna

    RECRUITING

    Ferrara, 44124, Italy

  • Azienda Sanitaria Territoriale Pesaro Urbino

    RECRUITING

    Pesaro, 61122, Italy

  • Bacs-Kiskun Varmegyei Oktatokorhaz

    RECRUITING

    Kecskemét, 6000, Hungary

  • Bnai zion MC

    RECRUITING

    Haifa, 34561, Israel

  • CHU Limoges

    RECRUITING

    Limoges, 87000, France

  • CHU de Bordeaux

    RECRUITING

    Pessac, 33604, France

  • Cancer Treatment Centers of America (CTCA)

    RECRUITING

    Zion, Illinois, 60099, United States

  • Cantonal Hospital Baden

    RECRUITING

    Baden, 5404, Switzerland

  • Central Alabama Research

    RECRUITING

    Birmingham, Alabama, 35209, United States

  • Centre Hospitalier Intercommunal de Creteil

    RECRUITING

    Créteil, 94010, France

  • Centre Hospitalier Lyon Sud

    RECRUITING

    Pierre-Bénite, 69495, France

  • Charing Cross Hospital

    RECRUITING

    London, Greater London, United Kingdom

  • Clatterbridge Cancer Centre - Liverpool

    RECRUITING

    Liverpool, Merseyside, L7 8YA, United Kingdom

  • Clinica Mi Tres Torres Barcelona - Giromed Institute

    RECRUITING

    Barcelona, Catalonia, 8017, Spain

  • Clinica Universidad de Navarra

    RECRUITING

    Pamplona, 31008, Spain

  • Clinica Universidad de Navarra (Madrid)

    RECRUITING

    Madrid, 28027, Spain

  • Cliniques universitaires Saint-Luc

    RECRUITING

    Brussels, 1200, Belgium

  • Curie Oncology

    RECRUITING

    Singapore, 329563, Singapore

    Contact Email: •••••@•••••

  • DHR Health Oncology Institute

    RECRUITING

    Edinburg, Texas, 78539, United States

  • Edward Cancer Center

    RECRUITING

    Naperville, Illinois, 60540-6766, United States

  • Elmhurst Hospital Nancy Knowles Cancer Center

    RECRUITING

    Elmhurst, Illinois, 60126, United States

  • Emek Medical Center

    RECRUITING

    Afula, 1834111, Israel

  • Evangelische Lungenklinik Berlin

    RECRUITING

    Berlin, 13125, Germany

  • Fakultni nemocnice Olomouc FNOL

    RECRUITING

    Olomouc, 779 00, Czechia

  • Farkasgyepui Tudogyogyintezet

    RECRUITING

    Farkasgyepű, 8582, Hungary

  • Florida Cancer Affiliates - Ocala Oncology

    RECRUITING

    Ocala, Florida, 34474, United States

  • Franciscan Health Indianapolis

    RECRUITING

    Indianapolis, Indiana, 46237, United States

  • General University Hospital in Prague

    RECRUITING

    Prague, 12808, Czechia

  • HFR Freiburg-Kantonsspital

    RECRUITING

    Fribourg, 1752, Switzerland

  • Hoag Family Cancer Institute - Hoag Memorial Hospital

    RECRUITING

    Newport Beach, California, 92663, United States

  • Hopital Europeen

    RECRUITING

    Marseille, 13003, France

  • Hopital Prive du Confluent

    RECRUITING

    Nantes, 44277, France

  • Hospital Regional Universitario de Malaga

    RECRUITING

    Málaga, 29010, Spain

  • Hospital Ruber Internacional

    RECRUITING

    Madrid, 28034, Spain

  • Hospital Universitario Arnau de Vilanova

    RECRUITING

    Lleida, 25198, Spain

  • Hospital Universitario Virgen del Rocio

    RECRUITING

    Seville, Andalusia, 41013, Spain

  • Hospital Universitario de Torrejon

    RECRUITING

    Torrejón de Ardoz, Madrid, 28850, Spain

  • Hospital Universitario del Vinalopo

    RECRUITING

    Elche, Alicante, 3293, Spain

  • Houston Methodist Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Humanitas Gavazzeni

    RECRUITING

    Bergamo, 24125, Italy

  • IRCCS - Istituto Romagnolo per lo Studio Dei Tumori, Dino Amadori

    RECRUITING

    Meldola, 47014, Italy

  • Icon Cancer Centre Singapore (Singapore Oncology Consultants)

    RECRUITING

    Singapore, 574623, Singapore

  • Institut Catala d'Oncologia

    RECRUITING

    Barcelona, 8916, Spain

  • Institut Curie

    RECRUITING

    Paris, 75005, France

  • Jason Bates at University of Texas Health Science Center

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Karl Landsteiner Institut fur Lungenforschung und pneumologische Onkologie c/o Klinik Floridsdorf

    RECRUITING

    Vienna, 1210, Austria

  • Klinik Loewenstein gGmbH

    RECRUITING

    Löwenstein, 74245, Germany

  • Krankenhaus Martha-Maria Halle-Dolau

    RECRUITING

    Halle, 06120, Germany

  • Luminis Health Radiation Oncology - Anne Arundel Health System

    RECRUITING

    Annapolis, Missouri, 21401, United States

  • Medisch Centrum Leeuwarden (MCL) - Oncologisch Centrum Leeuwarden (OCL)

    RECRUITING

    Friesland, 8934 AD, Netherlands

  • Methodist Richardson Cancer Center

    RECRUITING

    Richardson, Texas, 75082, United States

    Contact Email: •••••@•••••

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • MultiCare Deaconess Cancer and Blood Specialty Center - Downtown

    RECRUITING

    Spokane, Washington, 99218, United States

  • MultiCare Institute for Research & Innovation

    RECRUITING

    Tacoma, Washington, 98405, United States

  • MultiCare Regional Cancer Center

    RECRUITING

    Auburn, Washington, 98001, United States

  • MultiCare Regional Cancer Center

    RECRUITING

    Gig Harbor, Washington, 98335, United States

  • MultiCare Regional Cancer Center

    RECRUITING

    Puyallup, Washington, 98372, United States

  • NCCS Singapore

    RECRUITING

    Singapore, 168583, Singapore

    Contact Email: •••••@•••••

  • Nemocnice Agel Ostrava-Vitkovice / Agel Ostrava-Vitkovice Hospital

    RECRUITING

    Ostrava, 70300, Czechia

  • New York Cancer & Blood Specialists (NYCBS)

    RECRUITING

    New Hyde Park, New York, 11042, United States

  • New York Cancer & Blood Specialists (NYCBS)

    RECRUITING

    New York, New York, 10028, United States

  • New York Cancer & Blood Specialists (NYCBS)

    RECRUITING

    Shirley, New York, 19967, United States

  • New York Cancer & Blood Specialists (NYCBS)

    RECRUITING

    The Bronx, New York, 10469, United States

  • Northwest Oncology & Hematology

    RECRUITING

    Barrington, Illinois, 60010, United States

  • Nouvel Hopital Civil (NHC)

    RECRUITING

    Strasbourg, 67091, France

  • Old Parkland Hospital Hematology Oncology Clinic

    RECRUITING

    Dallas, Texas, 75235, United States

  • Ospedale Isola Tiberina Gemelli

    RECRUITING

    Rome, 00186, Italy

  • Parkview Packnett Family Cancer Institute

    RECRUITING

    Fort Wayne, Indiana, 46845, United States

  • Pius-Hospital Oldenburg

    RECRUITING

    Oldenburg, 26121, Germany

  • Rijnstate Ziekenhuis

    RECRUITING

    Arnhem, 6815AD, Netherlands

  • Saitama Medical University International Medical Center

    RECRUITING

    Hidaka, Saitama, 350-1298, Japan

  • St Antonius Ziekenhuis

    RECRUITING

    Utrecht, 3543 AZ, Netherlands

  • St. Jansdal ziekenhuis

    RECRUITING

    Harderwijk, 3844 DG, Netherlands

  • St. Jude Herritage Medical Group

    RECRUITING

    Fullerton, California, 92835, United States

  • Sutter Institute for Medical Research

    RECRUITING

    Sacramento, California, 95816, United States

  • The Royal Marsden NHS Foundation Trust

    RECRUITING

    London, London, SW3 6JJ, United Kingdom

  • The Royal Marsden NHS Foundation Trust - Sutton

    RECRUITING

    Sutton, Sutton, SM2 5PT, United Kingdom

  • Thoraxklinik Heidelberg

    RECRUITING

    Heidelberg, 69126, Germany

  • Tolna Varmegyei Balassa Janos Korhaz

    RECRUITING

    Szekszárd, 7100, Hungary

  • UT Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75235, United States

  • Universita Campus Bio-Medico di Roma (UCBM) - Policlinico Universitario

    RECRUITING

    Roma, 00128, Italy

  • Universitaetsklinik fuer Innere Medizin V Innsbruck

    RECRUITING

    Innsbruck, 6020, Austria

  • University Hospital Giessen, ZIM IV

    RECRUITING

    Giessen, 35392, Germany

  • University Hospital Salzburg

    RECRUITING

    Salzburg, 5020, Austria

  • University Hospitals of Leicester NHS Trust

    RECRUITING

    Leicester, Leicestershire, LE1 5WW, United Kingdom

  • University of Kansas Cancer Center

    RECRUITING

    Westwood, Kansas, 66205, United States

  • University of Kansas Cancer Center - Lee's Summit

    RECRUITING

    Lee's Summit, Missouri, 64064, United States

  • University of Kansas Cancer Center - North

    RECRUITING

    Kansas City, Missouri, 64154, United States

  • University of Kansas Cancer Center - Overland Park

    RECRUITING

    Overland, Missouri, 66210, United States

  • University of Rochester Medical Center

    RECRUITING

    Rochester, New York, 14642, United States

  • Uniwersytecki Szpital Kliniczny

    RECRUITING

    Poznan, 60-693, Poland

  • WakeMed Health & Hospitals

    RECRUITING

    Cary, North Carolina, 27518, United States

  • Western Regional Medical Center, LLC

    RECRUITING

    Goodyear, Arizona, 85338, United States

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