Spots Global Cancer Trial Database for A Study of IRESSA Treatment Beyond Progression in Addition to Chemotherapy Versus Chemotherapy Alone
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Trial Identification
Brief Title: A Study of IRESSA Treatment Beyond Progression in Addition to Chemotherapy Versus Chemotherapy Alone
Official Title: A Phase III Randomised, Double Blind, Placebo Controlled, Parallel, Multicentre Study to Assess the Efficacy and Safety of Continuing IRESSA 250 mg in Addition to Chemotherapy Versus Chemotherapy Alone in Patients Who Have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) and Have Progressed on First Line IRESSA
Study ID: NCT01544179
Conditions
Study Description
Brief Summary: The purpose of this study is to assess the efficacy and safety of gefitinib in patients who have progressed on first line gefitinib, comparing continuing gefitinib in addition to cisplatin plus pemetrexed combination chemotherapy versus cisplatin plus pemetrexed combination chemotherapy alone.
Detailed Description: A Phase III Randomised, Double blind, Placebo controlled, Parallel, Multicentre Study to Assess the Efficacy and Safety of continuing IRESSA 250 mg in addition to Chemotherapy versus Chemotherapy alone in Patients who have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) and have progressed on First Line IRESSA.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, Beijing, , China
Research Site, Beijing, , China
Research Site, Beijing, , China
Research Site, Beijing, , China
Research Site, Beijing, , China
Research Site, Beijing, , China
Research Site, Changchun, , China
Research Site, Changchun, , China
Research Site, Chengdu, , China
Research Site, Chengdu, , China
Research Site, Dalian, , China
Research Site, Guangzhou, , China
Research Site, Guangzhou, , China
Research Site, Hangzhou, , China
Research Site, Kunming, , China
Research Site, Nanjing, , China
Research Site, Shanghai, , China
Research Site, Shanghai, , China
Research Site, Shenyang, , China
Research Site, Shijiazhuang, , China
Research Site, Suzhou, , China
Research Site, Taiyuan, , China
Research Site, Wuhan, , China
Research Site, Xi'an, , China
Research Site, Ürümqi, , China
Research Site, Clermont Ferrand, , France
Research Site, Lille, , France
Research Site, Lyon, , France
Research Site, Paris, , France
Research Site, Villejuif, , France
Research Site, Hamburg, , Germany
Research Site, Löwenstein, , Germany
Research Site, Würzburg, , Germany
Research Site, Hong Kong, , Hong Kong
Research Site, Shatin, , Hong Kong
Research Site, Budapest, , Hungary
Research Site, Budapest, , Hungary
Research Site, Genova, , Italy
Research Site, Parma, , Italy
Research Site, Perugia, , Italy
Research Site, Pisa, , Italy
Research Site, Roma, , Italy
Research Site, Roma, , Italy
Research Site, Rozzano, , Italy
Research Site, Fukuoka-shi, , Japan
Research Site, Kashiwa, , Japan
Research Site, Osakasayama, , Japan
Research Site, Sakai-shi, , Japan
Research Site, Sunto-gun, , Japan
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, St.Petersburg, , Russian Federation
Research Site, Barcelona, , Spain
Research Site, Barcelona, , Spain
Research Site, Madrid, , Spain
Research Site, Majadahonda, , Spain
Research Site, Málaga, , Spain
Research Site, Sevilla, , Spain
Research Site, Zaragoza, , Spain
Research Site, Taichung, , Taiwan
Research Site, Taipei, , Taiwan
Contact Details
Name: Yuri Rukazenkov, MD PhD, GCL Oncology
Affiliation: AstraZeneca Global R&D, Alderley park, Cheshire, SK10 4TG, UK
Role: STUDY_DIRECTOR
Name: Tony Mok, M.D.
Affiliation: Department of Clinical Oncology, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, N.T., Hong KongDepartment of Clinical Oncology, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, N.T., Hong Kong
Role: PRINCIPAL_INVESTIGATOR
Name: Jean-Charles Soria, MD, PHD
Affiliation: Institute Gustave Roussy, France
Role: PRINCIPAL_INVESTIGATOR
Name: Haiyi Jiang, M.D. MSc
Affiliation: Zhangjiang Hi-tech Park, 3F, Room 3102, 199 Liangjing Road, Pudong Shanghai, postal code:201203
Role: STUDY_DIRECTOR
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