An Observational Study of Tarceva (Erlotinib) in Routine Practice For First Line Maintenance Therapy in Patients With Non Small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT01194050 |
Recruitment Status
:
Completed
First Posted
: September 2, 2010
Last Update Posted
: November 2, 2016
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
Tracking Information | ||||
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First Submitted Date | September 1, 2010 | |||
First Posted Date | September 2, 2010 | |||
Last Update Posted Date | November 2, 2016 | |||
Study Start Date | June 2010 | |||
Actual Primary Completion Date | July 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
Overall survival at 1 year [ Time Frame: 12 months ] | |||
Original Primary Outcome Measures | Same as current | |||
Change History | Complete list of historical versions of study NCT01194050 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | |||
Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | An Observational Study of Tarceva (Erlotinib) in Routine Practice For First Line Maintenance Therapy in Patients With Non Small Cell Lung Cancer | |||
Official Title | Erlotinib (Tarceva) in Routine Clinical Practice for First Line Maintenance Therapy (1LM) in Patients With Advanced Non Small Cell Lung Cancer (NSCLC) | |||
Brief Summary | This observational study will investigate the tolerability and efficacy of Tarceva (erlotinib) in daily clinical practice under routine conditions in patients with locally advanced or metastatic non small cell lung cancer. Data will be collected for approximately 12 months. | |||
Detailed Description | Not Provided | |||
Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Probability Sample | |||
Study Population | Non small cell lung cancer patients | |||
Condition | Non-Squamous Non-Small Cell Lung Cancer | |||
Intervention | Not Provided | |||
Study Groups/Cohorts | Cohort | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
289 | |||
Original Estimated Enrollment |
600 | |||
Actual Study Completion Date | July 2013 | |||
Actual Primary Completion Date | July 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Germany | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01194050 | |||
Other Study ID Numbers | ML22816 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Hoffmann-La Roche | |||
Study Sponsor | Hoffmann-La Roche | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | Hoffmann-La Roche | |||
Verification Date | November 2016 |