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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00805194 |
The present trial will be performed to evaluate whether BIBF 1120 in combination with standard therapy of docetaxel in patients with stage IIIB/IV or recurrent NSCLC is more effective as compared to placebo in combination with standard therapy of docetaxel. A secondary aim is to obtain safety information as well as information on quality of life of patients treated with BIBF 1120 in combination to standard therapy with docetaxel. In addition, blood will be collected for pharmacokinetic analysis.
Condition | Intervention | Phase |
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Carcinoma, Non-Small-Cell Lung |
Drug: BIBF 1120 Drug: placebo Drug: docetaxel |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Efficacy Study |
Official Title: | LUME Lung 1 Randomised Double Blind Phase III Trial of BIBF 1120 Versus Placebo in Addition to Standard Therapy of Docetaxel in Patients With Advanced NSCLC |
Estimated Enrollment: | 1306 |
Study Start Date: | December 2008 |
Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Boehringer Ingelheim Study Coordinator | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 1199.13, Eudra CT No: 2007-004803-36 |
Study First Received: | December 8, 2008 |
Last Updated: | April 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00805194 History of Changes |
Health Authority: | Austria: Agency for Health and Food Safety; Belarus: Ministry of Health of Republic of Belarus; Belgium: Federal Agency for Medicinal Products and Health Products; Bulgaria: Bulgarian Drug Agency; China: SDFA; Croatia: Ministry of Health and Social Welfare of the Republic of Croatia; Czech Republic: State Institute for Drug Control; Denmark: The Danish Medicines Agency; France: Afssaps - French Health Products Safety Agency; Georgia: Ministry of Health; Germany: Federal Institute for Drugs and Medical Devices; Great Britain: Medicines and Heathcare Products Regulatory Agency; Greece: Ministry of health & social solidarity national organization for medicines; India: Central Drug Standard Control Organization; Israel: Ministry of Health; Italy: The Italian Medicines Agency; Korea, Republic of: KFDA; Lithuania: Lithuanian Bioethics Committee; Poland: Agency for Registration of Medicinal Products, Medical Devices & Biocides; Portugal: National Pharmacy and Medicines Institute; Romania: National Medicines Agency; Russia: Federal Supervising Service for Public Health and Social Development of the Ministry of Health and Social Development of the Russian Federation; Slovakia: State Institute for Drug Control; South Africa: The Registrar, Department of Health, Medicines Control Council; Spain: Medicines and Healthcare Products Agency; Switzerland: Swissmedic; Ukraine: State Pharmacological Centre of Ministry of Health; United States: Food and Drug Administration |
Docetaxel Thoracic Neoplasms Respiratory Tract Diseases Lung Neoplasms Lung Diseases |
Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Pharmacologic Actions Carcinoma Docetaxel Neoplasms |
Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |