A Study of Tarceva (Erlotinib) and Standard of Care Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Tracking Information
Start Date ICMJE | March 2006 |
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Primary Completion Date | |
Current Primary Outcome Measures ICMJE (submitted: January 18, 2008) | Overall survival [ Time Frame: Event driven ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE (submitted: November 9, 2007) | Overall survival |
Change History | Complete list of historical versions of study NCT00556322 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: January 18, 2008) |
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Original Secondary Outcome Measures ICMJE (submitted: November 9, 2007) | Efficacy: progression-free survival; time to progression; objective respo |
Descriptive Information
Brief Title ICMJE | A Study of Tarceva (Erlotinib) and Standard of Care Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC) |
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Official Title ICMJE | An Open-label, Randomized Study to Evaluate the Effect of Tarceva, Compared With Alimta (Pemetrexed) or Taxotere (Docetaxel),on Survival in Patients With Advanced, Recurrent or Metastatic Non-small Cell Lung Cancer Who Have Experienced Disease Progression During Platinum-based Chemotherapy |
Brief Summary | This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva and that of standard of care chemotherapy in patients with advanced, recurrent, or metastatic NSCLC experiencing disease progression after failure of platinum-based chemotherapy.Eligible patients will be randomized to receive either Tarceva 150mg po daily, or comparator (either Alimta 500mg/m2 every 3 weeks, or Taxotere 75mg/m2 every 3 weeks). The anticipated time on study treatment is until disease progression ,and the target sample size is 500+ individuals. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Non-small Cell Lung Cancer |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 650 | ||||
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Estimated Completion Date | August 2014 | ||||
Primary Completion Date | |||||
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 | Australia, Austria, Belgium, Canada, Chile, China, Czech Republic, Denmark, France, Germany, Greece, Hungary, Italy, Korea, Republic of, Lithuania, Malaysia, New Zealand, Poland, Romania, Russian Federation, Slovakia, Slovenia, South Africa, Spain, Ukraine, United Kingdom, Venezuela |
Administrative Information
NCT ID ICMJE | NCT00556322 | ||||
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Responsible Party | Disclosures Group, Hoffmann-La Roche | ||||
Study ID Numbers ICMJE | BO18602 | ||||
Study Sponsor ICMJE | Hoffmann-La Roche | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Hoffmann-La Roche |
Source: http://clinicaltrials.gov/