NovoTTF-100L in Combination With Pemetrexed (Alimta®) for Advanced Non-small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT00749346 |
Recruitment Status :
Completed
First Posted : September 9, 2008
Last Update Posted : September 27, 2011
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Condition or disease | Intervention/treatment | Phase |
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Non-small Cell Lung Cancer NSCLC | Device: NovoTTF-100L | Phase 1 Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 42 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open Label Pilot Study of NovoTTF-100L in Combination With Pemetrexed (Alimta®) for Advanced Non-small Cell Lung Cancer |
Study Start Date : | May 2008 |
Actual Primary Completion Date : | July 2011 |
Actual Study Completion Date : | July 2011 |

Arm | Intervention/treatment |
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Experimental: A
Treatment with concomitant Alimta and NovoTTF-100L
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Device: NovoTTF-100L
TTFields treatment 12h/d for the duration of the study (until progression)concomitant to standard Alimta dosing
Other Names:
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- Device related toxicity [ Time Frame: until 2 months after treatment termination ]
- Time to progression [ Time Frame: Six months after recruitment of the last patient in the trial ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00749346
Switzerland | |
CCRC | |
Basel, Switzerland | |
Kantonspital Graubunden | |
Chur, Switzerland | |
Kantonspital Fribourg | |
Fribourg, Switzerland | |
Kantonspital Winterthur | |
Winterthur, Switzerland |
Principal Investigator: | Miklos Pless, MD | Kantonspital Winterthur |
Publications:
Responsible Party: | NovoCure Ltd. |
ClinicalTrials.gov Identifier: | NCT00749346 |
Other Study ID Numbers: |
EF-15 |
First Posted: | September 9, 2008 Key Record Dates |
Last Update Posted: | September 27, 2011 |
Last Verified: | September 2011 |
TTFields NSCLC Alimta Pemetrexed |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Carcinoma, Bronchogenic Bronchial Neoplasms Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |