A PHASE II MULTICENTRE RANDOMISED, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ZD1839 (IRESSA TM) (250MG TABLET) PLUS BEST SUPPORTIVE CARE (BSC) VERSUS PLACEBO PLUS BSC IN CHEMOTHERAPY-NAÏVE PATIENTS WITH ADVANCED (STAGE IIIB OR IV) NON-SMALL CELL LUNG CANCER (NSCLC) AND POOR PERFORMANCE STATUS

INTERVENTION: Product Name: Iressa (gefitinib) Product Code: ZD1839 Pharmaceutical Form: Tablet INN or Proposed INN: gefitinib Current Sponsor code: 1839IL0711 Other descriptive name: INSTEP Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 250‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: Non‐Small Cell Lung Cancer PRIMARY OUTCOME: Main Objective: To compare ZD1839 + best supportive care (BSC) versus placebo + BSC in terms of progression‐free survival Primary end point(s): Progression‐free survival Secondary Objective: 1. To compare ZD1839 + BSC versus placebo + BSC in terms of overall objective tumour response rate (complete response [CR] and partial response [PR]); 2. To compare ZD1839 + BSC versus placebo + BSC in terms of overall survival; 3. To compare ZD1839 + BSC versus placebo + BSC in terms of pulmonary symptom improvement; 4. To compare ZD1839 + BSC versus placebo + BSC in terms of quality of life; 5. To compare ZD1839 + BSC versus placebo + BSC in terms of tolerability; INCLUSION CRITERIA: 1.Provision of written informed consent 2.Male or female, aged 18 years and over 3.Histologically or cytological confirmation of non‐small cell lung carcinoma: adenocarcinoma (including bronchoalveolar), squamous cell carcinoma, large cell carcinoma or mixed (adenocarcinoma and squamous) or undifferentiated carcinoma. This may be from the initial diagnosis of NSCLC or subsequent biopsy. Note: sputum cytology alone is not acceptable. Cytological specimens obtained by brushing, washing or needle aspiration of a defined lesion are acceptable 4.NSCLC, locally advanced (Stage IIIB) or metastatic (stage IV) disease, not amenable to curative surgery or radiotherapy 5.Measurable disease according to RECIST criteria with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site. 6.Ability to provide plasma and urine samples for biomarker analysis 7.WHO performance status (PS) of 2 or 3 8.No