Titre 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
Protocole ID EF-24
ClinicalTrials.gov ID NCT02973789
Type(s) de cancer Poumon non à petites cellules
Phase Phase III
Stade Maladie avancée ou métastatique
Type étude Traitement
Médicament Tumor Treating Fields (TTFields)
Institution CIUSSS DE L'ESTRIE – CENTRE HOSP. UNIV. DE SHERBROOKE
   HOPITAL FLEURIMONT
      3001 12e Avenue Nord, Sherbrooke, QC, J1H 5N4
Ville Sherbrooke
Investigateur(trice) principal(e) Dre Nicole Bouchard
Coordonnateur(trice) Anick Champoux
 819-346-1110 poste 12811
Statut Fermé
Critètes d'éligibilité
  • 22 years of age and older
  • Life expectancy of ≥ 3 months
  • Histological diagnosis of squamous or non-squamous, inoperable, stage 4 NSCLC
  • Diagnosis of radiological progression while on or after first platinum-based systemic therapy
  • Randomization within 28 days of diagnosis of last progression
  • ECOG Score of 0-2
  • Assigned by the physician to receive either docetaxel or immune checkpoint inhibitor per standard of care regimens
  • Able to operate the NovoTTF-100L device independently or with the help of a caregiver
  • Signed informed consent for the study protocol
Critètes d'exclusion
  • Presence of brain metastasis or leptomeningeal spread of the disease
  • 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