First line IRESSA™ versus carboplatin/paclitaxel in Asia - IPASS

1. Primary Outcome Measure: Median progression free survival (PFS) in months   [ Time Frame: Tumour assessments as per RECIST were performed at baseline and then every 42 days ± 7 days from randomization until data cut off (14th April 2008). ]

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2. Secondary Outcome Measure: Median Overall Survival (OS) in Months at OS data cut off (14th June 2010)   [ Time Frame: Following the PFS DCO on 14th April 2008 information on survival status was collected every 8 weeks. ]

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3. Secondary Outcome Measure: Objective tumour response rate according to RECIST   [ Time Frame: Tumour assessments as per RECIST were performed at baseline and then every 42 days ± 7 days from randomization until data cut off (14th April 2008). ]

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4. Secondary Outcome Measure: Common Toxicity Criteria (CTC) grade 3, 4, or 5 neutropenia   [ Time Frame: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel ]

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5. Secondary Outcome Measure: Common Toxicity Criteria (CTC) grade 3, 4, or 5 thrombocytopenia   [ Time Frame: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel ]

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6. Secondary Outcome Measure: Common Toxicity Criteria (CTC) grade 3, 4, or 5 leukopenia   [ Time Frame: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel ]

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7. Secondary Outcome Measure: Common Toxicity Criteria (CTC) grade 3, 4, or 5 anaemia   [ Time Frame: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel ]

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8. Secondary Outcome Measure: Neurotoxicity   [ Time Frame: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel ]

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9. Secondary Outcome Measure: Rashes/acnes   [ Time Frame: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel ]

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10. Secondary Outcome Measure: Diarrhoea   [ Time Frame: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel ]

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11. Secondary Outcome Measure: Nausea   [ Time Frame: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel ]

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12. Secondary Outcome Measure: Vomiting   [ Time Frame: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel ]

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13. Secondary Outcome Measure: Common Toxicity Criteria (CTC) grade 3, 4, or 5 liver transaminases   [ Time Frame: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel ]

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14. Secondary Outcome Measure: Quality of life (QoL) as measured by the total score of the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) questionnaire   [ Time Frame: FACT-L data were collected at baseline, week 1, every 3 weeks (from baseline) until day 127, then every 42 days until the patient was confirmed as having objectively progressed (via RECIST), and at treatment discontinuation. ]

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15. Secondary Outcome Measure: Quality of life (QoL) as measured by the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) questionnaire   [ Time Frame: FACT-L data were collected at baseline, week 1, every 3 weeks (from baseline) until day 127, then every 42 days until the patient was confirmed as having objectively progressed (via RECIST), and at treatment discontinuation. ]

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16. Secondary Outcome Measure: Symptom improvement as measured by the Lung Cancer Subscale (LCS) of the FACT-L questionnaire   [ Time Frame: FACT-L data were collected at baseline, week 1, every 3 weeks (from baseline) until day 127, then every 42 days until the patient was confirmed as having objectively progressed (via RECIST), and at treatment discontinuation. ]

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