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Non-small Cell Lung CancerPhase 1/2NCT00749346

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

A Phase 1/2 study testing NovoTTF-100L in people with Non-small Cell Lung Cancer and NSCLC, run by NovoCure Ltd. at 4 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer, NSCLC
What is being tested?
NovoTTF-100L
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
4 sitesSwitzerland
Study dates
May 2008to Jul 2011
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 19Show fewer
  • 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).

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

4 sites in 1 country.

Switzerland4 sites

  • CCRC

    Basel

  • Kantonspital Graubunden

    Chur

  • Kantonspital Fribourg

    Fribourg

  • Kantonspital Winterthur

    Winterthur

Other trials in Switzerland

About this study

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

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.

Being tested
NovoTTF-100L
Keywords
TTFields, NSCLC, Alimta, Pemetrexed
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NovoTTF-100LDevice

    Also called TTFields, Pemetrexed, Alimta, Electric fields

    TTFields treatment 12h/d for the duration of the study (until progression)concomitant to standard Alimta dosing

Study groups in NCT00749346
Study groupRoleWhat they receive
AExperimentalTreatment with concomitant Alimta and NovoTTF-100L
Receives: Device: NovoTTF-100L

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Device related toxicity

    Measured: until 2 months after treatment termination

Secondary outcomes (1)

  1. Time to progression

    Measured: Six months after recruitment of the last patient in the trial

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionJul 2011
  4. Study completionJul 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00749346
Sponsor's protocol ID
EF-15
Status last verified
Sep 2011
First submitted
8 Sep 2008
Last updated
27 Sep 2011
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing NovoTTF-100L in people with Non-small Cell Lung Cancer and NSCLC, run by NovoCure Ltd. at 4 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Device related toxicity (time frame: until 2 months after treatment termination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00749346, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2011.

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