BIBW 2992 Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation
Tracking Information
Start Date ICMJE | August 2009 |
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Estimated Primary Completion Date | August 2011 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: July 29, 2009) | The primary endpoint will be progression free survival, as determined by RECIST 1.1. [ Time Frame: 2 years ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00949650 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: July 29, 2009) | Objective response (CR, PR) and Disease control (CR, PR, SD) according to RECIST 1.1, Overall survival, Deterioration of body weight and ECOG performance status, Health related quality of life (HRQOL), Pharmacokinetics of BIBW 2992, Safety of BIBW 2992 [ Time Frame: 2 years ] |
Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | BIBW 2992 Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation |
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Official Title ICMJE | LUX LUNG 3; A Randomised, Open-label, Phase III Study of BIBW 2992 Versus Chemotherapy as First-line Treatment for Patients With Stage IIIB or IV Adenocarcinoma of the Lung Harbouring an EGFR Activating Mutation |
Brief Summary | This randomised, open label phase III trial will be performed in patients with adenocarcinoma of the lung with tumours harbouring an EGFR activating mutation. The objectives of the trial are to compare the efficacy of single agent BIBW 2992 (Arm A) with Pemetrexed/Cisplatin chemotherapy (Arm B) as first line treatment for this group of patients. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Parallel Assignment, Efficacy Study |
Condition ICMJE |
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Intervention ICMJE |
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Recruitment Information
Estimated Enrollment ICMJE | 330 | ||||
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Completion Date | |||||
Estimated Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Argentina, Australia, Austria, Belgium, Canada, France, Germany, Hong Kong, Hungary, Ireland, Italy, Japan, Korea, Republic of, Malaysia, Mexico, Peru, Philippines, Romania, Russian Federation, Taiwan, Thailand, Ukraine, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00949650 | ||||
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Responsible Party | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim | ||||
Study ID Numbers ICMJE | 1200.32, EUDRACT 2008-005615-18 | ||||
Study Sponsor ICMJE | Boehringer Ingelheim Pharmaceuticals | ||||
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Investigators ICMJE |
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Information Provided By | Boehringer Ingelheim Pharmaceuticals |
Source: http://clinicaltrials.gov/