Non-small Cell Lung Cancer, NSCLC
Conditions
Keywords
TTFields, NSCLC, Alimta, Pemetrexed
Brief summary
An open-label phase I-II trial will be performed in 42 patients with pretreated locally advanced non-small cell lung cancer. The trial is designed to estimate the efficacy and to determine safety of NovoTTF-100L treatment combined with Pemetrexed for advanced NSCLC patients. Patients will receive standard Pemetrexed therapy (at 500 mg/m2 iv q3w for 3 cycles) concomitant to NovoTTF-100L therapy (12 hours a day, daily until the end of all three cycles of Alimta). Repeat treatments with Alimta + NovoTTF-100L will be offered as long as the patient is stable or responding. If there is a in-field response with progression outside of the NovoTTF field, Pemetrexed is to be stopped and third line chemotherapy with Docetaxel is to be initiated (35 mg/m2 weekly, d1, 8, 15, q 28 d).
Detailed description
The trial will be conducted in two stages. Fourteen patients will be recruited to a phase I stage of the trial. After all 14 patients have received 3 courses of Alimta (9 weeks of NovoTTF-100L treatment), these patients will be analyzed for toxicity. If the incidence of device related serious adverse events is \< 20%, the trial will continue to the second stage where 42 patients will be assessed for safety and efficacy as part of a phase II study (including the first 14 patients in the phase I study). Efficacy will be assessed based on local disease control in the lungs and liver, time to systemic disease progression, and overall survival. Patients will be followed for at least 6 months after the last course of NovoTTF-100L is applied to assess survival.
Interventions
DEVICENovoTTF-100L
TTFields treatment 12h/d for the duration of the study (until progression)concomitant to standard Alimta dosing
Sponsors
NovoCure Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) * Stage IV or IIIB with malignant pleural effusion, also locally advanced NSCLC not otherwise amenable to local treatment (surgery or radiotherapy) * One line of prior chemotherapy * Measurable disease * Greater or equal to 18 years * Life expectancy of at least 12 weeks * ECOG performance status 0-2 * Laboratory requirements at entry: * Blood cell counts: * Absolute neutrophils ≥ 1.0 x 109/L * Platelets ≥100 x 109/L * Hemoglobin ≥ 10 g/dl * Renal function: * Creatinine clearance ≥ 45 mL/min * Hepatic functions: * ASAT and ALAT ≤ 3 x UNL * Alkaline phosphatase ≤ 5 x UNL * Signed informed consent prior to start protocol specific requirements * Pregnancy test (β-HCG) must be negative (needed only for women of childbearing potential).
Exclusion criteria
* Known brain metastases or meningeal carcinomatosis * Other serious concomitant illness of medical conditions: * Congestive heart failure or angina pectoris except if it is medically controlled. * Previous history of myocardial infarction within 1 year from study entry. * Uncontrolled hypertension or arrhythmias * Implanted pacemaker, defibrillator or deep brain stimulation device * History of significant neurologic or psychiatric disorders including dementia or seizures * Active infection requiring iv antibiotics * Active ulcer, unstable diabetes mellitus or other contra-indication to corticosteroid therapy * Concurrent treatment with other experimental drugs * Participation in clinical trials with other experimental agents within 30 days of study entry * Psychological, familial, sociological or geographical conditions which don't permit medical follow-up and compliance with the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Device related toxicity | until 2 months after treatment termination |
Secondary
| Measure | Time frame |
|---|---|
| Time to progression | Six months after recruitment of the last patient in the trial |
Countries
Switzerland
Outcome results
None listed