Recurrent Non Small Cell Lung Cancer Clinical Trial
Official title:
A Randomized Phase II Study of Itraconazole and Pemetrexed in Patients With Previously Treated Non-Squamous Non-Small Cell Lung Cancer
Primary Objective
To evaluate the 3-month event-free survival of the combination of the combination of
itraconazole and pemetrexed in patients with recurrent/refractory non-small cell lung cancer.
Secondary Objectives
To determine the objective response rate of the combination of itraconazole and pemetrexed in
patients with recurrent/refractory non-small cell lung cancer.
Primary Objective
To evaluate the 3-month event-free survival of the combination of the combination of
itraconazole and pemetrexed in patients with recurrent/refractory non-small cell lung cancer.
3-month event-free survival (EFS) is defined as the proportion of patients who are alive and
without event after 3 months (evaluated in a window of +/- 1 week) of treatment. Events are
defined as disease progression or death from any cause. All patients treated on protocol will
be included in the determination of EFS, regardless of treatment modification or
discontinuation.
Secondary Objectives
To determine the objective response rate of the combination of itraconazole and pemetrexed in
patients with recurrent/refractory non-small cell lung cancer. The best overall response is
the best response recorded from the start of the treatment until disease
progression/recurrence (taking as reference for progressive disease the smallest measurements
recorded since the treatment started). The patient's best response assignment will depend on
the achievement of both measurement and confirmation criteria.
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