A Phase IIIb Randomized, Double-Blind Study Comparing Maintenance ZD1839 (IRESSA®) or Placebo Following Completion of Front Line, Platinum-Based, Double Chemotherapy in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer
- Must sign Informed Consent
- Females and males aged 18 years and over.
- Confirmed stage IIIB (T4-pleural effusion) and IV NSCLC.
- Either complete response, partial response, or stable disease following at least 4
cycles (3 in the setting of intolerable toxicity) but no more than 6 cycles of
definitive front line, platinum-based, doublet chemotherapy.
- No prior EGFR therapy
- No newly diagnosed intracerebral metastases while receiving or after completing
- At least 3 weeks (21 days) but no more than 4 weeks (28 days) since last dose of
- Must be completely healed from previous major oncologic surgery
- Life expectancy of ≥ 8 weeks.
- 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
- Treatment with a non-approved or investigational drug within 30 days before Day 1 of
- Signs of neurological symptoms consistent with new onset spinal cord compression or
- 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
- Males must also be willing to practice acceptable methods of birth control while
taking the drug to prevent pregnancy of a partner.