Spots Global Cancer Trial Database for Safety and Efficacy Study of Icotinb in Non-small Cell Lung Cancer (NSCLC) Patients
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Safety and Efficacy Study of Icotinb in Non-small Cell Lung Cancer (NSCLC) Patients
Official Title: A Randomized,Double-blind,Multicenter Phase III Trial to Evaluate the Safety and Efficacy of Icotinib and Gefitinib in Advanced NSCLC Patients Previously Treated With Chemotherapy
Study ID: NCT01040780
Conditions
Study Description
Brief Summary: The purpose of this study is to determine whether Icotinib is at least non-inferior to Gefitinib in the treatment of advanced non-small cell lung cancer (NSCLC) patients after one or two chemotherapies.
Detailed Description: Lung cancer is the rapidest increased type of cancer in China with over 5 times incidence rate increase during the past 30 years . It is the leading cause of death of cancer in man and 2nd in women. With the development of gefitinib and erlotinib, EGFR-TKI (epidermal growth factor receptor -tyrosine kinase inhibitor) is the most successful novel drugs developed for the treatment of these patients in recent years, especially for NSCLC patients in Asia including China. Icotinib is a novel EGFR-TKI developed by a group of Chinese scientists and clinician. It appears to be at least as good as gefitinib in terms of efficacy and better in terms of safety in phase I/II trials. In this study, a randomized, double-blind, gefitinib as control, multi-center phase III trial was designed to evaluate the safety and efficacy of icotinib in the treatment of advanced NSCLC patients after failure of 1 or 2 chemotherapy. PFS (progress free survival) is the primary end-point with OS (overall survival), ORR (objective response), TTP (time to progress), HRQOL and safety as the secondary end-point. A total of 400 patients will be recruited. EGFR and K-ras gene mutational analysis as well as a population PK study have also been proposed.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Beijing Chao-Yang Hospital, Beijing, Beijing, China
Cancer Hospital, Chinese Academy of Medical Science, Beijing, Beijing, China
Peking Union Medical College Hospital, Beijing, Beijing, China
Bejing Cancer Hospital, Beijing, Beijing, China
307 Hospital of PLA, Beijing, Beijing, China
Peking University Third Hospital, Beijing, Beijing, China
Chinese PLA General Hospital, Beijing, Beijing, China
Beijing Chest Hospital, Beijing, Beijing, China
Third Affiliated Hospital, Third Military Medical University, Chongqing, Chongqing, China
Guanghzou General Hospital of PLA, Guangzhou, Guangdong, China
Guangdong General Hospital, Guangzhou, Guangdong, China
Nanfang Hospital， Southern Medical University, Guangzhou, Guangdong, China
Sun yat-sen Univerisity Cancer Center, Guanzhou, Guangdong, China
the Second Xiangya Hospital，Central South University, Changsha, Hunan, China
Hunan Cancer Hospital, Changsha, Hunan, China
81 Hospital of PLA, Nanjing, Jiangsu, China
Nanjing General Hospital of Nanjing Command，PLA, Nanjing, Jiangsu, China
Jiangsu Cancer Hospital, Nanjing, Jiangsu, China
Jilin Cancer Hospital, Changchun, Jilin, China
Ruijin Hospital，Shanghai Jiao-Tong University, Shanghai, Shanghai, China
Zhongshan Hospital，Fudan University, Shanghai, Shanghai, China
Changhai Hospital， Second Military Medical University, Shanghai, Shanghai, China
Shanghai Pulmonary Hospital, Shanghai, Shanghai, China
Tangdu Hospital, Fourth Military Medical University, Xi-an, Shanxi, China
Xijing Hospital, Fourth Military Medical University, Xi-An, Shanxi, China
The First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
Contact Details
Name: Yan Sun, M.D.
Affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Role: PRINCIPAL_INVESTIGATOR
Name: Li Zhang, M.D.
Affiliation: Sun Yat-sen University
Role: PRINCIPAL_INVESTIGATOR
Name: Fenlai Tan, M.D./Ph.D.
Affiliation: Zhejiang Betapharma Inc.
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
