An Exploratory Phase 2 Study of Pemetrexed/Cisplatin as Pre-operative Chemotherapy in the Treatment of Stage IIIAN2 Nonsquamous Non-Small Cell Lung Cancer
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)
- No prior therapy for lung cancer
- Measurable disease according to version 1.1 of 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- Have previously completed or withdrawn from this study or any other study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