Maintenance ZD1839 (IRESSA®) Following Completion of Front Line, Platinum-Based, Double Chemotherapy in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer

Exclusion Criteria

• •Known severe hypersensitivity to ZD1839 or any of the excipients of these products.
• •Any evidence of clinically active interstitial lung disease (subjects with chronic, stable, radiographic changes who are asymptomatic need not be excluded).
• •Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.
• •Any unresolved chronic toxicity greater than common toxicity criteria (CTC) grade 2 from previous anticancer therapy excluding peripheral neuropathy or alopecia.
• •Evidence of any significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.
• •Pregnancy or breast feeding (women of child bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy.
• •Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
• •Signs of neurological symptoms consistent with new onset spinal cord compression or CNS metastases.
• •Treatment with any systemic anticancer therapies other than the prescribed protocol chemotherapy regimen (refer to Inclusion criterion -). Exception: Palliative radiotherapy for symptom relief of lesions present at diagnosis will be allowed; however, this radiotherapy must occur prior to completion of pre-study doublet chemotherapy.
• •Males must also be willing to practice acceptable methods of birth control while taking the drug to prevent pregnancy of a partner.