A Randomized, Open-Label, Parallel Group, International, Multicenter, Phase III Study of Oral ZD1839 (IRESSA®) Versus Intravenous Docetaxel (TAXOTERE®) in Patients With Locally Advanced or Metastatic Recurrent Non-Small Cell Lung Cancer Who Have Previously Received Platinum-Based Chemotherapy

Inclusion Criteria:

- Measurable (uni dimensional) disease by RECIST criteria in a lesion not previously
irradiated or non measurable disease

- Locally advanced or metastatic NSCLC, not amenable to curative surgery or
radiotherapy

- Advanced non-small cell lung cancer (NSCLC) that has recurred or progressed after
receiving prior treatment with platinum-based chemotherapy

- WHO performance status (PS) 0-2

- Absolute Neutrophil Count (ANC) >1.5 x 109/liter (L) and platelets >100 x 109/L

- Life expectancy of at least 8 weeks

Exclusion Criteria:

- Prior ZD1839 therapy

- Prior docetaxel treatment for NSCLC

- Less than 14 days since completion of prior radiotherapy

- Less than 21 days since prior chemotherapy, immunotherapy or biological systemic
anticancer therapy

- Evidence of clinically active Interstitial Lung Disease

- Other co-existing malignancies or malignancies diagnosed within the last 5 years with
the exception of basal cell carcinoma or cervical cancer in situ

- Newly diagnosed CNS metastases that have not yet been treated with surgery and/or
radiation. Patients with previously diagnosed and treated CNS metastases or spinal
cord compression may be considered if they have evidence of clinically SD (no steroid
therapy or steroid dose being tapered) for at least 28 days

- Patients with pre existing peripheral neuropathy >= grade 2 (NCI CTC criteria)