A Nested Case-control Study to Determine the Relative Risk of and Risk Factors for Interstitial Lung Disease in a Cohort of NSCLC Patients Treated With and Without Gefitinib

AstraZeneca1 个研究点分布在 1 个国家目标入组 6,000 人开始时间: 2003年11月最近更新: 2011年1月28日

适应症

试验速览

The purposes of this study are:

To estimate the relative risk of ILD in advanced/recurrence NSCLC patients treated with gefitinib as compared to other chemotherapy treatment, and to assess the risk factors for ILD in advanced/recurrence NSCLC patients undergoing treatment
To provide an estimate of the incidence of ILD in a group of advanced/recurrence NSCLC patients undergoing treatment

•Advanced/recurrence NSCLC patients who have had one or more chemotherapy regimens.
•Patients who are to be treated with gefitinib or chemotherapy
•Cohort: All advanced/recurrence NSCLC patients participating in this post-marketing clinical study

•Patients judged by the investigator(s) to have ILD (provisional cases) among those registered in the cohort OR Randomly selected patients without ILD (controls) for each provisional case
•Case-control study: Patients enrolled in the case-control study; all consenting patients with ILD as cases and approximately 4 times as many consenting patients without ILD as controls randomly selected from the cohort

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