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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02973789
Recruitment Status : Active, not recruiting
First Posted : November 25, 2016
Last Update Posted : May 17, 2023
Sponsor:
Information provided by (Responsible Party):
NovoCure Ltd. ( NovoCure GmbH )

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Nonsmall Cell Lung Cancer NSCLC Device: NovoTTF-200T Drug: Immune checkpoint inhibitors or docetaxel Phase 3

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 276 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2016
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Docetaxel

Arms and Interventions
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Arm Intervention/treatment
Experimental: NovoTTF-200T
Patients receive TTFields using the NovoTTF-200T device together with immune checkpoint inhibitors or docetaxel
 Device: NovoTTF-200T

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 Name: TTFields

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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Overall survival of patients treated with TTFields + docetaxel vs. docetaxel alone (superiority analysis) [ Time Frame: 4 years ]
  2. Overall survival of patients treated with TTFields + immune checkpoint inhibitors vs. immune checkpoint inhibitors alone (superiority) [ Time Frame: 4 years ]
  3. Overall Survival of patients treated with TTFields + docetaxel Vs. immune checkpoint inhibitors alone (non-inferiority analysis) [ Time Frame: 4 years ]
  4. 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 ]
  5. 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 ]
  6. Quality of life using the EORTC QLQ C30 questionnaire with LC13 addendum [ Time Frame: 4 years ]
  7. 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 ]
  8. 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 ]
  9. The effect of treatment compliance with NovoTTF-200T on overall survival and progression free survival outcomes [ Time Frame: 4 years ]
  10. Adverse events, severity and frequency based on Common Terminology Criteria for Adverse Events (CTCAE) V4.03 [ Time Frame: 4 years ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02973789


Locations
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Sponsors and Collaborators
NovoCure GmbH
More Information
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Publications:

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Responsible Party: NovoCure GmbH
ClinicalTrials.gov Identifier: NCT02973789    
Other Study ID Numbers: EF-24
First Posted: November 25, 2016    Key Record Dates
Last Update Posted: May 17, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by NovoCure Ltd. ( NovoCure GmbH ):
Non-Small Cell Lung Cancer
NSCLC
Treatment
Minimal Toxicity
TTFields
TTF
 Tumor Treating Fields
Novocure
Docetaxel
PD-1 inhibitor
PD-L1 inhibitor
Immune checkpoint inhibitor
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
 Bronchial Neoplasms
Docetaxel
Immune Checkpoint Inhibitors
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological