CompletedNCT00749346Updated Sep 27, 2011

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

A Phase 1/2 interventional study of NovoTTF-100L in Non-small Cell Lung Cancer and NSCLC, sponsored by NovoCure Ltd.. Completed at 4 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-09-27.

Sponsored by NovoCure Ltd. · Phase 1/2, Interventional, and Treatment

Phase: Phase 1/2
Study type: Interventional
Enrollment: 42
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study 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).

Read the 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.

Conditions studied

Non-small Cell Lung Cancer
NSCLC

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Keywords

TTFields
NSCLC
Alimta
Pemetrexed

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 42 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

NovoCure Ltd. is the lead sponsor of 19 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: 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

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

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 42 participants (estimated)

Study arms

Experimental
A
Treatment with concomitant Alimta and NovoTTF-100L
Device: NovoTTF-100L

Interventions

DeviceNovoTTF-100L
TTFields treatment 12h/d for the duration of the study (until progression)concomitant to standard Alimta dosing
Also known as: TTFields, Pemetrexed, Alimta, Electric fields

What researchers measure

Primary outcomes

Device related toxicity
Time frame: until 2 months after treatment termination

Secondary outcomes

Time to progression
Time frame: Six months after recruitment of the last patient in the trial

Study locations

4 sites

CCRC
Basel, Switzerland
Kantonspital Graubunden
Chur, Switzerland
Kantonspital Fribourg
Fribourg, Switzerland
Kantonspital Winterthur
Winterthur, Switzerland

References and documents

Publications

Kirson ED, Gurvich Z, Schneiderman R, Dekel E, Itzhaki A, Wasserman Y, Schatzberger R, Palti Y. Disruption of cancer cell replication by alternating electric fields. Cancer Res. 2004 May 1;64(9):3288-95. doi: 10.1158/0008-5472.can-04-0083. PubMed 15126372 ↗
Kirson ED, Dbaly V, Tovarys F, Vymazal J, Soustiel JF, Itzhaki A, Mordechovich D, Steinberg-Shapira S, Gurvich Z, Schneiderman R, Wasserman Y, Salzberg M, Ryffel B, Goldsher D, Dekel E, Palti Y. Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors. Proc Natl Acad Sci U S A. 2007 Jun 12;104(24):10152-7. doi: 10.1073/pnas.0702916104. Epub 2007 Jun 5. PubMed 17551011 ↗
Salzberg M, Kirson E, Palti Y, Rochlitz C. A pilot study with very low-intensity, intermediate-frequency electric fields in patients with locally advanced and/or metastatic solid tumors. Onkologie. 2008 Jul;31(7):362-5. doi: 10.1159/000137713. Epub 2008 Jun 24. PubMed 18596382 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 27, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00749346
Lead sponsor: NovoCure Ltd.
Responsible party: Sponsor
First posted: Sep 9, 2008
Start date: May 2008
Primary completion: Jul 2011
Completion: Jul 2011
Last update: Sep 27, 2011

Study contacts

Miklos Pless, MD

principal investigator · Kantonspital Winterthur

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.

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