NovoTTF-100L in Combination With Pemetrexed (Alimta®) for Advanced Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Open Label Pilot Study of NovoTTF-100L in Combination With Pemetrexed (Alimta®) for Advanced Non-small Cell Lung Cancer

Conditions
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Non-small Cell Lung Cancer, NSCLC

Intervention / Treatment
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* Device: NovoTTF-100L


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Treatment with concomitant Alimta and NovoTTF-100L | Device: NovoTTF-100L<br>* TTFields treatment 12h/d for the duration of the study (until progression)concomitant to standard Alimta dosing<br>* Other names: Electric fields;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device related toxicity |  | until 2 months after treatment termination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression |  | Six months after recruitment of the last patient in the trial | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TTFields, NSCLC, Alimta, Pemetrexed