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
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