Effect of Tumor Treating Fields (TTFields) (150 kHz) Concurrent With Standard of Care Therapies for Treatment of Stage 4 Non-small Cell Lung Cancer (NSCLC) Following Platinum Failure (LUNAR)

September 26, 2023 updated by: NovoCure GmbH

LUNAR: Pivotal, Randomized, Open-label Study of Tumor Treating Fields (TTFields) Concurrent With Standard of Care Therapies for Treatment of Stage 4 Non-small Cell Lung Cancer (NSCLC) Following Platinum Failure

The study is a prospective, randomized controlled phase III trial aimed to test the efficacy and safety of TTFields, using the NovoTTF-200T device, concurrent with standard therapies for stage 4 NSCLC patients, following progression while on or after platinum based treatment. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

Study Overview

Detailed Description

PAST PRE-CLINICAL AND CLINICAL EXPERIENCE:

The effect of the electric fields (TTFields, TTF) has demonstrated significant activity in in vitro and in vivo NSCLC pre-clinical models both as a single modality treatment and in combination with chemotherapies and PD-1 inhibitors. TTFields have been demonstrated to act synergistically with taxanes and have been shown to be additive when combined with PD-1 inhibitors. In addition, TTFields have shown to inhibit metastatic spread of malignant melanoma in in vivo experiment.

In a pilot study, 42 patients with advanced NSCLC who had had tumor progression after at least one line of prior chemotherapy, received pemetrexed together with TTFields (150 kHz) applied to the chest and upper abdomen until disease progression (Pless M., et al., Lung Cancer 2011). The combination was well tolerated and the only device-related adverse event was mild to moderate contact dermatitis. Efficacy endpoints were remarkably high compared to historical data for pemetrexed alone.

In addition, a phase III trial of Optune® (200 kHz) as monotherapy compared to active chemotherapy in recurrent glioblastoma patients showed TTFields to be equivalent to active chemotherapy in extending survival, associated with minimal toxicity, good quality of life, and activity within the brain (14% response rate) (Stupp R., et al., EJC 2012). Finally, a phase III trial of Optune® combined with maintenance temozolomide compared to maintenance temozolomide alone has shown that combined therapy led to a significant improvement in both progression free survival and overall survival in patients with newly diagnosed glioblastoma without the addition of high grade toxicity and without decline in quality of life (Stupp R., et al., JAMA 2015).

DESCRIPTION OF THE TRIAL:

All patients included in this trial are patients with squamous or non-squamous, stage 4 NSCLC who had disease progression on or after receiving platinum based chemotherapy. In addition, all patients must meet all eligibility criteria.

Eligible patients will be randomly assigned to one of two groups:

Patients receive docetaxel or immune checkpoint inhibitor in combination with TTFields using the NovoTTF-100L System.

Patients receive docetaxel or immune checkpoint inhibitor without TTFields. Patients will be randomized at a 1:1 ratio. Baseline tests will be performed in patients enrolled in both arms. If assigned to the NovoTTF-100L group, the patients will be treated continuously with the device until disease progression in the thorax and/or liver according to RECIST or irRECIST (Immune-Related Response Evaluation Criteria In Solid Tumors) (depending if the patient is receiving docetaxel or immune checkpoint inhibitor, respectively).

On both arms, patients who have disease progression according to RECIST or irRECIST (depending if the patient is receiving docetaxel or immune checkpoint inhibitor, respectively) will switch to a third line treatment according to local practice.

SCIENTIFIC BACKGROUND:

Electric fields exert forces on electric charges similar to the way a magnet exerts forces on metallic particles within a magnetic field. These forces cause movement and rotation of electrically charged biological building blocks, much like the alignment of metallic particles seen along the lines of force radiating outwards from a magnet.

Electric fields can also cause muscles to twitch and if strong enough may heat tissues. TTFields are alternating electric fields of low intensity. This means that they change their direction repetitively many times a second. Since they change direction very rapidly (150 thousand times a second), they do not cause muscles to twitch, nor do they have any effects on other electrically activated tissues in the body (brain, nerves and heart). Since the intensities of TTFields in the body are very low, they do not cause heating.

The breakthrough finding made by Novocure was that finely tuned alternating fields of very low intensity, now termed TTFields (Tumor Treating Fields), cause a significant slowing in the growth of cancer cells. Due to the unique geometric shape of cancer cells when they are multiplying, TTFields cause electrically-charged cellular components of these cells to change their location within the dividing cell, disrupting their normal function and ultimately leading to cell death. In addition, cancer cells also contain miniature building blocks which act as tiny motors in moving essential parts of the cells from place to place. TTFields interfere with the normal orientation of these tiny motors related to other cellular components since they are electrically-charged as well. As a result of these two effects, tumor cell division is slowed, results in cellular death or reverses after continuous exposure to TTFields.

Other cells in the body (normal healthy tissues) are affected much less than cancer cells since they multiply at a much slower rate if at all. In addition TTFields can be directed to a certain part of the body, leaving sensitive areas out of their reach. Finally, the frequency of TTFields applied to each type of cancer is specific and may not damage normally dividing cells in healthy tissues.

In conclusion, TTFields hold the promise of serving as a brand new treatment for NSCLC with very few side effects.

Study Type

Interventional

Enrollment (Actual)

276

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Salzburg, Austria, 5020
        • Medical University Salzburg, State Hospital, University hospital for internal medicine III / PMU
      • Brussels, Belgium, 1000
        • Institut Jules Bordet - Department of Intensive Care and Thoracic Oncology
      • Herstal, Belgium, 4040
        • Clinique André Renard Herstal Oncologie
      • Mechelen, Belgium, 2800
        • AZ Sint Maarten
      • Plovdiv, Bulgaria, 4004
        • Complex Oncology Center (COC) - Plovdiv EOOD,
    • Quebec
      • Montréal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUSSS de l'Estrie - CHUS)
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Center
      • Guangzhou, China
        • Sun Yat-sen University Cancer Center
    • Beijing
      • Beijing, Beijing, China
        • Beijing Cancer Hospital
    • Guangdong
      • Guangzhou, Guangdong, China
        • Affiliated Cancer Hospital of Guangzhou Medical University
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Henan Cancer Hospital
      • Zhengzhou, Henan, China, 45003
        • Henan Provincial People's Hospital
    • Shandong
      • Zibo, Shandong, China, 250014
        • PKUCare Luzhong Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 31000
        • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
      • Hangzhou, Zhejiang, China, 311000
        • Zhejiang Cancer Hospital
      • Zagreb, Croatia, 10000
        • University Hospital Centre Zagreb
      • Prague, Czechia
        • General University Hospital in Prague
      • Prague, Czechia
        • Thomayerova Nemocnice Dept. of Pneumology
      • Vitkovice, Czechia
        • Vitkovicka nemocnice
      • Beauvais, France, 60021
        • Centre Hospitalier de Beauvais
      • Bordeaux, France
        • INSTITUT BERGONIE Centre Régional de Lutte Contre le Cancer
      • Lorient, France, 56100
        • Groupe Hospitalier Bretagne Sud
      • Nîmes, France, 30029
        • CHU Caremeau Service de Pneumologie
      • Paris, France
        • AH-HP Hôpital Saint Louis
      • Saint-Quentin, France, 21000
        • Centre Hospitalier de Saint-Quentin Service de pneumologie
      • Halle (Saale), Germany
        • Universitätsklinikum Halle - Universitätsklinik und Poliklinik für Innere Medizin IV
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
      • Szekszárd, Hungary, 7100
        • Tolna County, Balassa Janos Hospital, Department of oncology
      • Genova, Italy, 16132
        • ASL 3, Ospedale Villa Scassi
      • Meldola, Italy
        • IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
      • Ravenna, Italy
        • UOC Oncologia Medica Presidio Ospedaliero di Ravenna AUSL della Romagna
      • Saronno, Italy, 21047
        • Saronno Hospital
      • Harderwijk, Netherlands
        • St Jansdal Ziekenhuis
      • Rotterdam, Netherlands, 3015
        • Erasmus MC
      • Gdansk, Poland
        • Uniwersyteckie Centrum Kliniczne
      • Lublin, Poland
        • MS Clinsearch Specjalistyczny NZOZ
      • Poznan, Poland
        • Clinical Hospital of Przemienienia Pańskiego UM in Poznaniu
      • Szczecin, Poland, 70-891
        • Samodzielny Publiczny Wojewodzki Szpital Zespolony w Szczecinie
      • Łódź, Poland
        • Centrum Terapii Współczesnej
      • Belgrade, Serbia, 11080
        • Bezanijska kosa Clinical Hospital Center
      • Kragujevac, Serbia, 34000
        • University Clinical Center Kragujevac
      • Barcelona, Spain
        • Hospital Quirón Teknon, Instituto Oncológico Dr. Rosell
      • Madrid, Spain
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain
        • Hospital Universitario Puerta de Hierro
      • Madrid, Spain
        • Hospital Universitario Gregorio Marañón
      • Málaga, Spain
        • Hospital Regional Universitario Carlos Haya Medical Oncology Department
      • Toledo, Spain, 45071
        • Hospital Virgen de la Salud
      • Valencia, Spain
        • Hospital Universitari i Politecnic La Fe
    • Catalonia
      • Lleida, Catalonia, Spain
        • Hospital Universitario Arnau de Vilanova
      • Winterthur, Switzerland, 8400
        • Kantonsspital Winterthur Tumorzentrum Winterthur
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Central Alabama Research
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Ironwood Cancer & Research Center
      • Phoenix, Arizona, United States, 85004
        • Cancer Center at St. Joseph Hospital and Medical Center
    • California
      • Beverly Hills, California, United States, 90211
        • Beverly Hills Cancer Center
      • Fresno, California, United States, 93720
        • California Cancer Associates for Research and Excellence, Inc. cCARE
      • Fullerton, California, United States, 92835
        • St. Joseph Heritage Healthcare
      • Laguna Hills, California, United States, 92653
        • Saddleback Memorial Medical Center
      • Redlands, California, United States, 92373
        • Redlands Community Hospital (Emad Ibrahim, MD, Inc.)
      • Sacramento, California, United States, 95816
        • Sutter Institute for Medical Research
      • Sacramento, California, United States, 95186
        • Dignity Health - Mercy Cancer Centers
      • Whittier, California, United States, 90603
        • Innovative Clinical Research Institute
    • Colorado
      • Greeley, Colorado, United States, 80631
        • Banner MD Anderson Cancer Center at North Colorado Medical Center
    • Connecticut
      • Fairfield, Connecticut, United States, 06824
        • Associated Neurologists of Southern CT, P.C.
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Cancer Institute at MedStar Washington Hospital Center
    • Florida
      • Jacksonville, Florida, United States, 32204
        • GenesisCare USA
      • Miami, Florida, United States, 33176
        • Miami Cancer Institute
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Medical Center
      • Orlando, Florida, United States, 32804
        • AdventHealth Orlando
      • Orlando, Florida, United States, 32806
        • Adult Oncology Research
      • Plantation, Florida, United States
        • BRCR Medical Center Inc
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois Cancer Center
      • Peoria, Illinois, United States, 61615
        • Illinois CancerCare, P.C.
      • Springfield, Illinois, United States, 62702
        • Southern Illinois University, School of Medicine, Simmons Cancer Institute at SIU
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Franciscan Health Indianapolis
    • Kansas
      • Westwood, Kansas, United States, 66205
        • University of Kansas Cancer Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Norton Cancer Institute
      • Louisville, Kentucky, United States, 40202
        • University Medical Center, Inc; DBA University of Louisville
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane Cancer Center
      • New Orleans, Louisiana, United States, 70112
        • LSU Health Sciences Center -New Orleans
      • Shreveport, Louisiana, United States, 71105
        • CHRISTUS Health
    • Maine
      • Lewiston, Maine, United States
        • Central Maine Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland School of Medicine
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center, Division of Hematology and Oncology
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
      • Farmington Hills, Michigan, United States, 48336
        • Clinical Oncology Associates
      • Farmington Hills, Michigan, United States, 48336
        • Detroit Clinical Research Center
      • Ypsilanti, Michigan, United States, 48197
        • Saint Joseph Mercy Health System
    • Minnesota
      • Saint Paul, Minnesota, United States, 55101
        • HealthPartners Institute, Regions Cancer Care Center
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Cancer Institute
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Nebraska
      • Omaha, Nebraska, United States
        • University of Nebraska Medical Center
      • Omaha, Nebraska, United States, 68124
        • CHI Health Research Center
      • Omaha, Nebraska, United States, 68130
        • Oncology Hematology West, PC dba Nebraska Cancer Specialists
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • OptumCare Cancer Care
      • Reno, Nevada, United States, 89502
        • Renown Regional Medical Center Institute for Cancer
    • New Mexico
      • Albuquerque, New Mexico, United States, 87110
        • Presbyterian Cancer Center
    • New York
      • Flushing, New York, United States, 11355
        • New York-Presbyterian/Queens Radiation Oncology
      • Mount Kisco, New York, United States, 10549-3417
        • Northern Westchester Hospital
      • Stony Brook, New York, United States, 11794
        • Stony Brook Cancer Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Oncology Specialists of Charlotte
      • Salisbury, North Carolina, United States, 28144
        • W.G. Bill Hefner VA Med Center
      • Winston-Salem, North Carolina, United States, 27103
        • Piedmont Radiation Oncology, PA
    • Ohio
      • Akron, Ohio, United States, 44304
        • Summa Health
      • Toledo, Ohio, United States, 43623
        • Toledo Clinic Cancer Center
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Vita Medical Associates, P.C.
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Cancer Institute
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • UT/Erlanger Oncology & Hematology
    • Texas
      • Amarillo, Texas, United States, 79106
        • Texas Oncology - Amarillo
      • Arlington, Texas, United States, 76012
        • Texas Oncology - Arlington
      • Corpus Christi, Texas, United States, 78404
        • Christus Health Spohn Ministry
      • Dallas, Texas, United States, 75216
        • Dallas VA Medical Center
      • Dallas, Texas, United States, 75390
        • The University Of Texas Southwestern Medical Center
      • Dallas, Texas, United States, 75246
        • Texas Oncology- Baylor Charles A. Sammons Cancer Center
      • Houston, Texas, United States, 77030
        • Oncology Consultants, P.A.
      • McKinney, Texas, United States, 75071
        • Texas Oncology-McKinney
      • Paris, Texas, United States, 75460
        • Texas Oncology - Paris
      • Plano, Texas, United States, 75093
        • Texas Oncology- Plano West
      • Waco, Texas, United States, 76712
        • Baylor Scott & White Health/McClinton Cancer Center
      • Waco, Texas, United States, 76712
        • Texas Oncology-Waco
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute/University of Utah
    • Washington
      • Bellevue, Washington, United States, 98004
        • Overlake Medical Center & Clinics
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • UW Carbone Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 22 years of age and older (some regional variations to inclusion age exist)
  2. Life expectancy of ≥ 3 months
  3. Histological diagnosis of squamous or non-squamous, inoperable, metastatic NSCLC
  4. Diagnosis of radiological progression while on or after first platinum-based systemic therapy administered for advanced or metastatic disease.

    1. Patients who received adjuvant or neoadjuvant platinum-based chemotherapy (after surgery and/or radiation therapy) and developed metastatic disease within 6 months of completing therapy are eligible.
    2. Patients with metastatic disease more than 6 months after adjuvant or neoadjuvant platinum-based chemotherapy, who also subsequently progressed during or after a platinum- based regimen given to treat the advanced or metastatic disease, are eligible.
    3. Patients should not receive any systemic therapy after platinum failure before enrollment into the study. Maintenance therapy after platinum based therapy and prior to progression is allowed.
  5. ECOG Score of 0-2
  6. Assigned by the physician to receive either docetaxel or immune checkpoint inhibitor per standard of care regimen
  7. Able to operate the NovoTTF-200T device independently or with the help of a caregiver
  8. Signed informed consent for the study protocol

Exclusion Criteria:

  1. Metastases to central nervous system (CNS) with clinical symptoms or evidence of new metastases to CNS during screening. Patients who previously received treatments for the metastases to CNS, are stable and meet the following requirements are allowed to be enrolled:

    1. The patients are neurologically returned to baseline (except for residual signs or symptoms related to CNS treatment).
    2. No treatment for the metastases to CNS during the screening period (e.g. surgery, radiotherapy, corticosteroid therapy- prednisone > 10 mg/day or equivalent).
    3. No progress in CNS lesions as indicated by MRI within 14 days prior to randomization.
    4. No meningeal metastasis or spinal cord compression.
  2. Patients planned to receive immune checkpoint inhibitor with contra-indications to receive immunotherapy
  3. Patients planned to receive docetaxel with contra-indications to receive docetaxel
  4. Severe comorbidities:

    1. Clinically significant (as determined by the investigator) hematological, hepatic and renal dysfunction, defined as: Neutrophil count < 1.5 x 10^9/L and platelet count < 100 x 10^9/L; bilirubin > 1.5 x ULN; AST and/or ALT > 2.5 x ULN or > 5 x ULN if patient has documented liver metastases; and serum creatinine > 1.5 x ULN
    2. History of significant cardiovascular disease unless the disease is well controlled. Significant cardiac disease includes second/third degree heart block; significant ischemic heart disease; poorly controlled hypertension; congestive heart failure of the New York Heart Association (NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary activity results in fatigue, palpitation or dyspnea)
    3. History of arrhythmia that is symptomatic or requires treatment. Patients with atrial fibrillation or flutter controlled by medication are not excluded from participation in the trial
    4. History of pericarditis
    5. History of interstitial lung disease
    6. History of cerebrovascular accident (CVA) within 6 months prior to randomization or that is not stable
    7. Active infection or serious underlying medical condition that would impair the ability of the patient to received protocol therapy
    8. History of any psychiatric condition that might impair patient's ability to understand or comply with the requirements of the study or to provide consent
    9. Any other malignancy requiring anti-tumor treatment in the past three years, excluding treated stage I prostate cancer, in situ cervical cancer, in situ breast cancer and non-melanomatous skin cancer
  5. Concurrent treatment with other experimental treatments for NSCLC while on the study
  6. Implantable electronic medical devices (e.g. pacemaker, defibrillator) in the upper torso
  7. Known allergies to medical adhesives or hydrogel
  8. Pregnancy or breast-feeding (patients with reproductive potential must use effective contraception methods throughout the entire study period, as determined by their investigator/gynecologist)
  9. Admitted to an institution by administrative or court order

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NovoTTF-200T
Patients receive TTFields using the NovoTTF-200T device together with immune checkpoint inhibitors or docetaxel

Patients receive continuous TTFields treatment using the NovoTTF-200T device. TTFields treatment will consist of wearing four electrically insulated electrode arrays on the chest. The treatment enables the patient to maintain regular daily routine.

Other Name: TTFields

Drug: Immune checkpoint inhibitors or docetaxel Patients receive standard of care with Immune checkpoint inhibitors or docetaxel

Other Names:
  • TTFields
Patients receive standard of care with Immune checkpoint inhibitors or docetaxel
Active Comparator: Best Standard of Care
Patients receive best standard of care with immune checkpoint inhibitors or docetaxel
Patients receive standard of care with Immune checkpoint inhibitors or docetaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival of patients treated with TTFields + docetaxel or immune checkpoint inhibitors vs. docetaxel or immune checkpoint inhibitors alone (superiority analysis)
Time Frame: 4 years
4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival of patients treated with TTFields + docetaxel vs. docetaxel alone (superiority analysis)
Time Frame: 4 years
4 years
Overall survival of patients treated with TTFields + immune checkpoint inhibitors vs. immune checkpoint inhibitors alone (superiority)
Time Frame: 4 years
4 years
Overall Survival of patients treated with TTFields + docetaxel Vs. immune checkpoint inhibitors alone (non-inferiority analysis)
Time Frame: 4 years
4 years
Progression-free survival of patients treated with docetaxel or immune checkpoint inhibitors + TTFields vs. docetaxel or immune checkpoint inhibitors alone, based on RECIST Criteria
Time Frame: 4 years
4 years
Overall radiological response rate (based on RECIST criteria) of patients treated with docetaxel or Immune checkpoint inhibitors + TTFields vs. docetaxel or immune checkpoint inhibitors alone.
Time Frame: 4 years
4 years
Quality of life using the EORTC QLQ C30 questionnaire with LC13 addendum
Time Frame: 4 years
4 years
Analyses of the effects of NovoTTF-200T with each type of immune checkpoint inhibitor on overall survival and progression free survival
Time Frame: 4 years
4 years
Analysis of the effects of NovoTTF-200T on overall survival and progression free survival within each histological subgroup (squamous and non-squamous)
Time Frame: 4 years
4 years
The effect of treatment compliance with NovoTTF-200T on overall survival and progression free survival outcomes
Time Frame: 4 years
4 years
Adverse events, severity and frequency based on Common Terminology Criteria for Adverse Events (CTCAE) V4.03
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Estimated)

September 1, 2023

Study Completion (Estimated)

September 1, 2023

Study Registration Dates

First Submitted

November 22, 2016

First Submitted That Met QC Criteria

November 22, 2016

First Posted (Estimated)

November 25, 2016

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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