Spots Global Cancer Trial Database for First Line Treatment in EGFR Mutation Positive Advanced NSCLC Patients With Central Nervous System (CNS) Metastases
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Trial Identification
Brief Title: First Line Treatment in EGFR Mutation Positive Advanced NSCLC Patients With Central Nervous System (CNS) Metastases
Official Title: A Randomized, Open-label, Controlled, Multi-Center Phase II/III Study to Assess the Efficacy and Safety of AZD3759 vs. a Standard of Care EGFR TKI, as First Line Treatment to EGFR Mutation Positive Advanced NSCLC With CNS Metastases
Study ID: NCT03653546
Study Description
Brief Summary: The first-line treatment with single agent AZD3759 results in superior Progression Free Survival (PFS) compared to Standard of Care (SoC) Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKI), in patients with advanced EGFR mutation positive non-small cell lung cancer (NSCLC) with Central Nervous System (CNS) metastasis
Detailed Description: This is a Phase II/III randomized, open-label, multicenter study to compare the efficacy and safety of first line single-agent AZD3759 vs. Erlotinib or Gefitinib treatment in patients with advanced EGFR mutation positive NSCLC with CNS metastases. Eligible patients with documented EGFR mutation+ (L858R and/or Exon 19Del) TKI-naïve advanced NSCLC and documented intracranial disease will be enrolled.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
China site, Hefei, Anhui, China
China site, Fuzhou, Fujian, China
China site, Xiamen, Fujian, China
China site, Guangzhou, Guangdong, China
China site, Guangzhou, Guangdong, China
China site, Haerbin, Heilongjiang, China
China site, Zhengzhou, Henan, China
China site, Zhengzhou, Henan, China
China site, Wuhan, Hubei, China
China site, Wuhan, Hubei, China
China site, Wuhan, Hubei, China
China site, Yichang, Hubei, China
China site, Changsha, Hunan, China
China site, Nanjing, Jiangsu, China
China site, Nanjing, Jiangsu, China
China site, Suzhou, Jiangsu, China
China site, Wuxi, Jiangsu, China
China site, Xuzhou, Jiangsu, China
China site, Yangzhou, Jiangsu, China
China site, Changchun, Jilin, China
China site, Changchun, Jilin, China
China site, Xi'an, Shaanxi, China
China site 0123, Jinan, Shandong, China
China site, Linyi, Shandong, China
China site, Weifang, Shandong, China
China site, Yantai, Shandong, China
China site, Chengdu, Sichuan, China
China site, Kunming, Yunnan, China
China site, Hangzhou, Zhejiang, China
China site, Hangzhou, Zhejiang, China
China site, Hangzhou, Zhejiang, China
China site, Beijing, , China
China site, Beijing, , China
China site, Beijing, , China
China site, Beijing, , China
China site, Chongqing, , China
China site, Chongqing, , China
China site, Chongqing, , China
China site, Shanghai, , China
China site, Shanghai, , China
China site, Tianjin, , China
Korea Site, Chungbuk, , Korea, Republic of
Korea site, Daegu, , Korea, Republic of
Korea site, Gyeonggi-do, , Korea, Republic of
Korea site, Gyeongsang, , Korea, Republic of
Korea site, Incheon, , Korea, Republic of
Korea Site, Seoul, , Korea, Republic of
Korea site, Seoul, , Korea, Republic of
Korea Site, Seoul, , Korea, Republic of
Korea site, Seoul, , Korea, Republic of
Korea site, Seoul, , Korea, Republic of
Korea site, Suwon, , Korea, Republic of
Korea site, Ulsan, , Korea, Republic of
Singapore site, Singapore, , Singapore
Taiwan site, Taichung, , Taiwan
Taiwan site, Tainan, , Taiwan
Taiwan site, Taipei, , Taiwan
Taiwan site, Taoyuan, , Taiwan
Contact Details
Name: Yilong Wu, M.D.
Affiliation: Guangdong Provincial People's Hospital
Role: STUDY_CHAIR
Name: Myung-Ju Ahn, M.D.
Affiliation: Samsung Medical Center, Sungkyunkwan University School of Medicine
Role: PRINCIPAL_INVESTIGATOR
Name: Jie Wang, M.D.
Affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Role: PRINCIPAL_INVESTIGATOR
Name: Qing Zhou, M.D.
Affiliation: Guangdong Provincial People's Hospital
Role: PRINCIPAL_INVESTIGATOR
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