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

NovoCure

Status and phase

Completed

Phase 2

Phase 1

Conditions

Non-small Cell Lung Cancer

NSCLC

Treatments

Device: NovoTTF-100L

Study type

Interventional

Funder types

Industry

Identifiers

NCT00749346

EF-15

Details and patient eligibility

About

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).

Full 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.

Enrollment

42 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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