EF-24/LUNAR: Randomized, open-label approval study of Tumor Treating Fields (TTFields) simultaneously with therapies according to the treatment standard for the treatment of non-small cell lung cancer (NSCLC) stage 4 after platinum failure

Austria, Belgium, Bulgaria, Canada, China, Croatia, Czech Republic, Czechia, France, Germany, Hong Kong, Hungary, Italy, Netherlands, Poland, Serbia, Spain, Switzerland, United States (ICTRP)

ICTRP Studien-ID
NCT02973789 (ICTRP)

Offizieller Titel (Genehmigt von der Ethikkommission)
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 (BASEC)

Wissenschaftlicher Titel
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 (ICTRP)

Öffentlicher Titel
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) (ICTRP)

Untersuchte Krankheit(en)
Nonsmall Cell Lung Cancer;NSCLC (ICTRP)

Untersuchte Intervention
Device: NovoTTF-200T;Drug: Immune checkpoint inhibitors or docetaxel (ICTRP)

Studientyp
Interventional (ICTRP)

Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)

Ein-/Ausschlusskriterien
Gender: All
Maximum age: N/A
Minimum age: 22 Years
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 (ICTRP)

nicht verfügbar

Primäre und sekundäre Endpunkte
Overall survival of patients treated with TTFields + docetaxel or immune checkpoint inhibitors vs. docetaxel or immune checkpoint inhibitors alone (superiority analysis) (ICTRP)

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

Registrierungsdatum
22.11.2016 (ICTRP)

Einschluss des ersten Teilnehmers
nicht verfügbar

Sekundäre Sponsoren
nicht verfügbar

Weitere Kontakte
Katy Kerschen, clinicaltrials@novocure.com, +1 603 206 2337 (ICTRP)

Sekundäre IDs
EF-24 (ICTRP)

Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar

Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT02973789 (ICTRP)