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Brief Title: Assess the Efficacy, Safety and Tolerability of Gefitinib (Iressa® 250mg) as Maintenance Therapy in Locally Advanced or Metastatic (Stage IIIB/IV) Non Small Cell Lung Cancer (NSCLC)
Official Title: A Placebo-Controlled, Multicentre, Randomised, Parallel Group, Trial to Assess the Efficacy, Safety and Tolerability of Gefitinib (Iressa® 250mg) as Maintenance Therapy in Locally Advanced or Metastatic (StageIIIB/IV) Non Small Cell Lung Cancer (NSCLC) Chinese Patients Who HaveNot Experienced Disease Progression or Unacceptable Toxicity During Front Line Standard Platinum-Based Chemotherapy
Study ID: NCT00770588
Brief Summary: This is a double blind, multicentre, randomized, placebo-controlled study. The eligible patients will be randomized to receive gefitinib or placebo at 1:1 ratio. This study will recruit 296 male or female, histologically or cytologically diagnosed locally advanced or metastatic NSCLC patients with a World Health Organization (WHO) Performance Status (PS) 0-2. Patients must have completed 4 cycles of platinum based first line doublet chemotherapy without experiencing disease progression or unacceptable toxicity. The chemotherapy shall be given every 3 weeks, which includes cisplatin or carboplatin, combined with any one of the following: gemcitabine, paclitaxel, docetaxel, vinorelbine.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Research Site, Beijing, Beijing, China
Research Site, Fuzhou, Fujian, China
Research Site, Guangzhou, Guangdong, China
Research Site, Nanning, Guangxi, China
Research Site, Zhengzhou, Henan, China
Research Site, Wuhan, Hubei, China
Research Site, Nanjing, Jiangsu, China
Research Site, Changchun, Jilin, China
Research Site, Shengyang, Liaoning, China
Research Site, Shanghai, Shanghai, China
Research Site, Xi'an, Shanxi, China
Research Site, Chengdu, Sichuan, China
Research Site, Tianjin, Tianjin, China
Research Site, Hangzhou, Zhejiang, China