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Phase 3 N=291 Randomized Treatment

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)

Nonsmall Cell Lung Cancer · NSCLC

Enrolled (actual)
291
Serious AEs
46.8%
Results posted
Mar 2026
Primary outcome: Primary: Overall Survival of Patients Treated With TTFields + Docetaxel or Immune Checkpoint Inhibitors vs. Docetaxel or Immune Checkpoint Inhibitors Alone (Superiority Analysis) — 13.2; 9.9 Months — p=0.041

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
NovoTTF-200T (Device); Immune checkpoint inhibitors or docetaxel (Drug)
Age
Adult, Older Adult · 22+ yrs
Sex
All
Sponsor
NovoCure GmbH
Primary completion
Sep 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Overall Survival of Patients Treated With TTFields + Docetaxel or Immune Checkpoint Inhibitors vs. Docetaxel or Immune Checkpoint Inhibitors Alone (Superiority Analysis)
13.2; 9.9 0.041 sig
SECONDARY
Overall Survival of Patients Treated With TTFields + Immune Checkpoint Inhibitors vs. Immune Checkpoint Inhibitors Alone (Superiority)
19.0; 10.8 0.024 sig
SECONDARY
Overall Survival of Patients Treated With TTFields + Docetaxel vs. Docetaxel Alone (Superiority Analysis)
11.1; 8.9 0.469
SECONDARY
Overall Survival of Patients Treated With TTFields + Docetaxel Vs. Immune Checkpoint Inhibitors Alone (Non-inferiority Analysis)
11.1; 10.8
SECONDARY
Progression-free Survival of Patients Treated With Docetaxel or Immune Checkpoint Inhibitors + TTFields vs. Docetaxel or Immune Checkpoint Inhibitors Alone, Based on RECIST Criteria
4.4; 4.2
SECONDARY
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.
28; 27
SECONDARY
Quality of Life Using the EORTC QLQ C30 Questionnaire With LC13 Addendum
0.0; 7.9; -8.0; 2.2; -12.5; 5.8
SECONDARY
Analyses of the Effects of NovoTTF-200T With Each Type of Immune Checkpoint Inhibitor on Overall Survival and Progression Free Survival
46.9; 12.7; 18.5; 10.0; 23.6; 30.0
SECONDARY
Analysis of the Effects of NovoTTF-200T on Overall Survival and Progression Free Survival Within Each Histological Subgroup (Squamous and Non-squamous)
13.2; 9.9; 13.9; 10.1; 5.3; 4.0
SECONDARY
The Effect of Treatment Compliance With NovoTTF-200T on Overall Survival and Progression Free Survival Outcomes
32; 109
SECONDARY
Adverse Events, Severity and Frequency Based on Common Terminology Criteria for Adverse Events (CTCAE) V4.03
15; 23; 34; 75; 59; 103

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.

Eligibility Criteria

Inclusion Criteria

  • 22 years of age and older (some regional variations to inclusion age exist)
  • Life expectancy of ≥ 3 months
  • Histological diagnosis of squamous or non-squamous, inoperable, metastatic NSCLC
  • Diagnosis of radiological progression while on or after first platinum-based systemic therapy administered for advanced or metastatic disease.
  • 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.
  • 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.
  • 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.
  • ECOG Score of 0-2
  • Assigned by the physician to receive either docetaxel or immune checkpoint inhibitor per standard of care regimen
  • Able to operate the NovoTTF-200T device independently or with the help of a caregiver
  • Signed informed consent for the study protocol

Exclusion Criteria

  • 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:
  • The patients are neurologically returned to baseline (except for residual signs or symptoms related to CNS treatment).
  • No treatment for the metastases to CNS during the screening period (e.g. surgery, radiotherapy, corticosteroid therapy- prednisone > 10 mg/day or equivalent).
  • No progress in CNS lesions as indicated by MRI within 14 days prior to randomization.
  • No meningeal metastasis or spinal cord compression.
  • Patients planned to receive immune checkpoint inhibitor with contra-indications to receive immunotherapy
  • Patients planned to receive docetaxel with contra-indications to receive docetaxel
  • Severe comorbidities:
  • Clinically significant (as determined by the investigator) hematological, hepatic and renal dysfunction, defined as: Neutrophil count 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
  • 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)
  • 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
  • History of pericarditis
  • History of interstitial lung disease
  • History of cerebrovascular accident (CVA) within 6 months prior to randomization or that is not stable
  • Active infection or serious underlying medical condition that would impair the ability of the patient to received protocol therapy
  • 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
  • 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
  • Concurrent treatment with other experimental treatments for NSCLC while on the study
  • Implantable electronic medical devices (e.g. pacemaker, defibrillator) in the upper torso
  • Known allergies to medica
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02973789). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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