A large placebo-controlled phase III study in patients with advanced NSCLC who had received one or two prior chemotherapy regimens, IRESSA Survival Evaluation in Lung Cancer (ISEL), showed some improvement in overall survival with single-agent gefitinib that failed to reach statistical significance compared with placebo in the overall or adenocarcinoma co-primary populations.
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A phase II study of single-agent gefitinib as first-line therapy in patients with stage IV non-small-cell lung cancer.
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