Chemotherapy With Pemetrexed in Combination With Platinum for Advanced Non-Small Cell Lung Cancer (NSCLC)

A Randomized Phase 2 Study of Pemetrexed in Combination With Cisplatin or Carboplatin in the First Line Therapy of Advanced NSCLC

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.

Inclusion Criteria:

• Cytologically and/or histologically confirmed NSCLC Stage IIIb or IV
• No previous systemic chemotherapy for this cancer
• At least one uni-dimensionally measurable lesion meeting Response Evaluation Criteria In Solid Tumors (RECIST) criteria
• Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1 and adequate organ function
• Prior radiation therapy allowed but limited to <25% of the patient's bone marrow

Exclusion Criteria:

• Serious concomitant systemic disorder or active infection
• Mild to moderate renal insufficiency, but unable to interrupt salicylates or other nonsteroidal anti-inflammatory drugs
• Symptomatic central nervous system (CNS) metastases requiring concurrent corticosteroid therapy
• Presence of clinically significant third-space fluid collections