Conditions: Non-Small-Cell Lung Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 133
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Pemetrexed intervention 2: Cisplatin intervention 3: Carboplatin
Intervention descriptions: intervention 1: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles intervention 2: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles intervention 3: Area under the concentration curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles

Protocol document: