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

Phase 1/Phase 2
18 Years
Not Enrolling
Non-small Cell Lung Cancer, NSCLC

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Trial Information

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

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.

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

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

- Active infection requiring iv antibiotics

- Active ulcer, unstable diabetes mellitus or other contra-indication to corticosteroid

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Device related toxicity

Outcome Time Frame:

until 2 months after treatment termination

Safety Issue:


Principal Investigator

Miklos Pless, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Kantonspital Winterthur


Switzerland: Swissmedic

Study ID:




Start Date:

May 2008

Completion Date:

July 2011

Related Keywords:

  • Non-Small Cell Lung Cancer
  • TTFields
  • Alimta
  • Pemetrexed
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms