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)

Completed · Phase 3

Conditions studied: Nonsmall Cell Lung Cancer, NSCLC

In brief

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.

Key facts

Study ID

NCT02973789

Run by

NovoCure GmbH

People needed

291

Starts

2016-12-01

Expected to finish

2024-10-09

Last updated by the study team

2026-03-18

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 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
• 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 medical adhesives or hydrogel
• Pregnancy or breast-feeding (patients with reproductive potential must use effective contraception methods throughout the entire study period, as determined by their investigator/gynecologist)
• Admitted to an institution by administrative or court order

Where it is running

• Ironwood Cancer & Research Center — Chandler, Arizona, United States
• Cancer Center at St. Joseph Hospital and Medical Center — Phoenix, Arizona, United States
• Beverly Hills Cancer Center — Beverly Hills, California, United States
• California Cancer Associates for Research and Excellence, Inc. cCARE — Fresno, California, United States
• St. Joseph Heritage Healthcare — Fullerton, California, United States
• Saddleback Memorial Medical Center — Laguna Hills, California, United States
• Redlands Community Hospital (Emad Ibrahim, MD, Inc.) — Redlands, California, United States
• Dignity Health - Mercy Cancer Centers — Sacramento, California, United States
• Sutter Institute for Medical Research — Sacramento, California, United States
• Innovative Clinical Research Institute — Whittier, California, United States
• Banner MD Anderson Cancer Center at North Colorado Medical Center — Greeley, Colorado, United States
• Associated Neurologists of Southern CT, P.C. — Fairfield, Connecticut, United States
• Washington Cancer Institute at MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• GenesisCare USA — Jacksonville, Florida, United States
• Miami Cancer Institute — Miami, Florida, United States
• Mount Sinai Medical Center — Miami Beach, Florida, United States
• AdventHealth Orlando — Orlando, Florida, United States
• Adult Oncology Research — Orlando, Florida, United States
• BRCR Medical Center INC — Plantation, Florida, United States
• University of Illinois Cancer Center — Chicago, Illinois, United States
• Illinois CancerCare, P.C. — Peoria, Illinois, United States
• Southern Illinois University, School of Medicine, Simmons Cancer Institute at SIU — Springfield, Illinois, United States
• Franciscan Health Indianapolis — Indianapolis, Indiana, United States
• University of Kansas Cancer Center — Westwood, Kansas, United States
• Central Alabama Research — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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