At a glance
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A Randomized Phase 2 Study of Pemetrexed in Combination With Cisplatin or Carboplatin in the First Line Therapy of Advanced NSCLC
In Brief
A Phase 2 clinical trial evaluating Pemetrexed, Cisplatin, and 1 other intervention for Non-Small-Cell Lung Cancer. Completed, enrolled 133 participants across 12 sites.
Detailed Summary
This is a two-arm, parallel, open-label, Phase 2 multicenter study of pemetrexed as first line combination therapy with either cisplatin or carboplatin in the palliative setting of stage IIIb and IV non-small cell lung cancer patients. Approximately 130 patients will be included in about 15 centers in Germany and randomized to one of the above treatment regimens in a 1:1 ratio. Chemotherapy will be administered over a maximum of six cycles with a standard length of 21 days. Primary objective will be the Progression Free Survival Time of patients as assessed in both treatment arms.
Study Details
Timeline
Interventions
500 mg/m2, intravenous (IV), every 21 days x 6 cycles
75 mg/m2, intravenous (IV), every 21 days x 6 cycles
Area under the concentration curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles