Spots Global Cancer Trial Database for BIBW 2992 and BSC Versus Placebo and BSC in Non-small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib (LUX-LUNG 1)
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Trial Identification
Brief Title: BIBW 2992 and BSC Versus Placebo and BSC in Non-small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib (LUX-LUNG 1)
Official Title: Phase IIb/III Randomized, Double-blind Trial of BIBW 2992 Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Non-small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib (LUX-Lung 1)
Study ID: NCT00656136
Conditions
Study Description
Brief Summary: This randomized, double-blind, multi-center Phase IIb/III trial will be performed in patients with NSCLC who have received previous treatment with at least one but not more than two lines of cytotoxic chemotherapy (one line must have been a platinum-containing regimen) and either gefitinib or erlotinib for a period of at least 12 weeks and then progressed. The primary objective of this randomized trial is to determine the efficacy of BIBW 2992 as a single agent (Arm A) as compared to a matching placebo (Arm B) in this patient population. Patients on both treatment arms will receive best supportive care in addition to study treatment. Patients enrolled into the trial will be treated and followed until death or lost to follow-up.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
1200.23.038 Boehringer Ingelheim Investigational Site, Kingman, Arizona, United States
1200.23.046 Boehringer Ingelheim Investigational Site, Fayetteville, Arkansas, United States
1200.23.027 Boehringer Ingelheim Investigational Site, Anaheim, California, United States
1200.23.028 Boehringer Ingelheim Investigational Site, Berkeley, California, United States
1200.23.029 Boehringer Ingelheim Investigational Site, Modesto, California, United States
1200.23.045 Boehringer Ingelheim Investigational Site, Montebello, California, United States
1200.23.009 Boehringer Ingelheim Investigational Site, Orange, California, United States
1200.23.026 Boehringer Ingelheim Investigational Site, Palm Springs, California, United States
1200.23.024 Boehringer Ingelheim Investigational Site, North Miami Beach, Florida, United States
1200.23.020 Boehringer Ingelheim Investigational Site, New York, New York, United States
1200.23.013 Boehringer Ingelheim Investigational Site, Valhalla, New York, United States
1200.23.056 Boehringer Ingelheim Investigational Site, Salt lake City, Utah, United States
1200.23.039 Boehringer Ingelheim Investigational Site, Renton, Washington, United States
1200.23.050 Boehringer Ingelheim Investigational Site, Seattle, Washington, United States
1200.23.32004 Boehringer Ingelheim Investigational Site, Edegem, , Belgium
1200.23.32003 Boehringer Ingelheim Investigational Site, Gent, , Belgium
1200.23.32001 Boehringer Ingelheim Investigational Site, Leuven, , Belgium
1200.23.32005 Boehringer Ingelheim Investigational Site, Liège, , Belgium
1200.23.32006 Boehringer Ingelheim Investigational Site, Namur, , Belgium
1200.23.1002 Boehringer Ingelheim Investigational Site, Edmonton, Alberta, Canada
1200.23.1005 Boehringer Ingelheim Investigational Site, Vancouver, British Columbia, Canada
1200.23.1009 Boehringer Ingelheim Investigational Site, Toronto, Ontario, Canada
1200.23.1001 Boehringer Ingelheim Investigational Site, Montreal, Quebec, Canada
1200.23.1004 Boehringer Ingelheim Investigational Site, Montreal, Quebec, Canada
1200.23.86001 Boehringer Ingelheim Investigational Site, Beijing, , China
1200.23.86002 Boehringer Ingelheim Investigational Site, Beijing, , China
1200.23.86003 Boehringer Ingelheim Investigational Site, Beijing, , China
1200.23.86009 Boehringer Ingelheim Investigational Site, Chengdu, , China
1200.23.86007 Boehringer Ingelheim Investigational Site, Guangzhou, , China
1200.23.86008 Boehringer Ingelheim Investigational Site, Hangzhou, , China
1200.23.86004 Boehringer Ingelheim Investigational Site, Shanghai, , China
1200.23.86005 Boehringer Ingelheim Investigational Site, Shanghai, , China
1200.23.86006 Boehringer Ingelheim Investigational Site, Shanghai, , China
1200.23.3303A Boehringer Ingelheim Investigational Site, Besançon Cedex, , France
1200.23.3303C Boehringer Ingelheim Investigational Site, Besançon Cedex, , France
1200.23.3305A Boehringer Ingelheim Investigational Site, Caen Cedex 5, , France
1200.23.3304A Boehringer Ingelheim Investigational Site, La Tronche, , France
1200.23.3304B Boehringer Ingelheim Investigational Site, La Tronche, , France
1200.23.3307A Boehringer Ingelheim Investigational Site, Lyon Cedex 4, , France
1200.23.3301A Boehringer Ingelheim Investigational Site, Paris cedex 20, , France
1200.23.3302A Boehringer Ingelheim Investigational Site, Paris, , France
1200.23.3302B Boehringer Ingelheim Investigational Site, Paris, , France
1200.23.3306A Boehringer Ingelheim Investigational Site, Toulouse cedex 9, , France
1200.23.3306C Boehringer Ingelheim Investigational Site, Toulouse cedex 9, , France
1200.23.49010 Zentralklinik Bad Berka GmbH, Bad Berka, , Germany
1200.23.49002 Innere Klinik und Poliklinik (Tumorforschung), Essen, , Germany
1200.23.49003 Asklepios Fachkliniken München-Gauting, Gauting, , Germany
1200.23.49005 Krankenhaus Großhansdorf, Großhansdorf, , Germany
1200.23.49008 Universitätsklinik Hamburg-Eppendorf, Hamburg, , Germany
1200.23.49004 Johannes Gutenberg-Universität Mainz, Mainz, , Germany
1200.23.49001 Universitätsklinikum Mannheim, Mannheim, , Germany
1200.23.49006 HSK, Dr. Horst-Schmidt-Kliniken GmbH, Wiesbaden, , Germany
1200.23.85202 Boehringer Ingelheim Investigational Site, Hong Kong, , Hong Kong
1200.23.39003 Boehringer Ingelheim Investigational Site, Genova, , Italy
1200.23.39007 Boehringer Ingelheim Investigational Site, Orbassano (TO), , Italy
1200.23.39002 Boehringer Ingelheim Investigational Site, Perugia, , Italy
1200.23.39004 Boehringer Ingelheim Investigational Site, Prato, , Italy
1200.23.39008 Boehringer Ingelheim Investigational Site, Roma, , Italy
1200.23.39001 Boehringer Ingelheim Investigational Site, Rozzano (MI), , Italy
1200.23.82005 Boehringer Ingelheim Investigational Site, Gyeonggi-do, , Korea, Republic of
1200.23.82006 Boehringer Ingelheim Investigational Site, Hwasun, , Korea, Republic of
1200.23.82001 Boehringer Ingelheim Investigational Site, Seoul, , Korea, Republic of
1200.23.82002 Boehringer Ingelheim Investigational Site, Seoul, , Korea, Republic of
1200.23.82003 Boehringer Ingelheim Investigational Site, Seoul, , Korea, Republic of
1200.23.82004 Boehringer Ingelheim Investigational Site, Seoul, , Korea, Republic of
1200.23.31002 Boehringer Ingelheim Investigational Site, Amsterdam, , Netherlands
1200.23.31001 Boehringer Ingelheim Investigational Site, Groningen, , Netherlands
1200.23.31003 Boehringer Ingelheim Investigational Site, Helmond, , Netherlands
1200.23.65001 Boehringer Ingelheim Investigational Site, Singapore, , Singapore
1200.23.3405 Boehringer Ingelheim Investigational Site, Barcelona, , Spain
1200.23.3404 Boehringer Ingelheim Investigational Site, Cruces, , Spain
1200.23.3401 Boehringer Ingelheim Investigational Site, Madrid, , Spain
1200.23.3403 Boehringer Ingelheim Investigational Site, Madrid, , Spain
1200.23.3406 Boehringer Ingelheim Investigational Site, Madrid, , Spain
1200.23.3402 Boehringer Ingelheim Investigational Site, Valencia, , Spain
1200.23.88604 Taichung Veterans General Hospital, Taichung, , Taiwan
1200.23.88605 China Medical University Hospital, Taichung, , Taiwan
1200.23.88606 National Cheng Kung University Hospital, Tainan, , Taiwan
1200.23.88601 National Taiwan University Hospital, Taipei, , Taiwan
1200.23.88602 Veterans General Hospital, Taipei, , Taiwan
1200.23.88607 Tri-Service General Hospital, Taipei, , Taiwan
1200.23.88603 Chang Gung Memorial Hosp-Linkou, Taoyuan, , Taiwan
1200.23.66001 Boehringer Ingelheim Investigational Site, Chiangmai, , Thailand
1200.23.66003 Boehringer Ingelheim Investigational Site, Pathumwan, Bangkok, , Thailand
1200.23.66002 Boehringer Ingelheim Investigational Site, Songkla, , Thailand
1200.23.4404 Boehringer Ingelheim Investigational Site, Dundee, , United Kingdom
1200.23.4403 Boehringer Ingelheim Investigational Site, Edinburgh, , United Kingdom
1200.23.4401 Boehringer Ingelheim Investigational Site, Glasgow, , United Kingdom
1200.23.4405 Boehringer Ingelheim Investigational Site, London, , United Kingdom
1200.23.4406 Boehringer Ingelheim Investigational Site, Sutton, , United Kingdom
Contact Details
Name: Boehringer Ingelheim
Affiliation: Boehringer Ingelheim
Role: STUDY_CHAIR
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