A Study of Pemetrexed/Cisplatin as Pre-operative Treatment of Early Stage Nonsquamous Non-Small Cell Lung Cancer

An Exploratory Phase 2 Study of Pemetrexed/Cisplatin as Pre-operative Chemotherapy in the Treatment of Stage IIIAN2 Nonsquamous Non-Small Cell Lung Cancer

The purpose of this trial is to assess how well the combination of pemetrexed with cisplatin can reduce tumor size.

Inclusion Criteria:

• Nonsquamous Non-Small Cell Lung Cancer that was confirmed by tissue biopsy
• Stage IIIAN2 disease (T1aN2, T1bN2, T2aN2, T2bN2, and T3N2)
• Tumor considered potentially resectable
• Good performance status (score of 0 or 1) according to Eastern Cooperative Oncology Group scale (ECOG)
• No prior therapy for lung cancer
• Measurable disease according to version 1.1 of Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
• Life expectancy of at least 6 months
• Organs are functioning well (bone marrow reserve, liver, kidney, lung)
• Signed Informed Consent
• Women must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen (for example, intrauterine device, birth control pills, or barrier device) during and for 6 months after last dose of study drug; must have a negative pregnancy test within 7 days before study enrollment; and must not be breast-feeding.
• Men must be surgically sterile, or compliant with a contraceptive regimen during and for 6 months after last dose of study drug.
• Be fit for surgery at the time of enrollment

Exclusion Criteria:

• Receiving or have received an investigational drug or device within the last 30 days
• Have previously completed or withdrawn from this study or any other study investigating pemetrexed
• Serious concomitant systemic disorder
• Serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease
• Receiving concurrent administration of any other anticancer therapy
• Have received a recent (within 30 days of enrollment) or are receiving concurrent yellow fever vaccination
• Inability or unwillingness to take Pemetrexed supplementation/premedication (folic acid, vitamin B12, or corticosteroids)
• Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose less than or equal to 1.3 grams per day