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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Device related toxicity
until 2 months after treatment termination
Miklos Pless, MD