An Observational Study of Tarceva (Erlotinib) in Routine Practice For First Line Maintenance Therapy in Patients With Non Small Cell Lung Cancer

Tracking Information
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; (submitted: September 1, 2010)	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; (submitted: September 1, 2010)	Tolerability of Tarceva in daily clinical practice under routine conditions [ Time Frame: 12 months ]; Efficacy of Tarceva in daily clinical practice under routine conditions [ Time Frame: 12 months ]; Reproducibility of the results of the controlled SATURN study [ Time Frame: 12 months ]
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
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.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: April 1, 2013)	289
Original Estimated Enrollment; (submitted: September 1, 2010)	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: Adult patients with locally advanced or metastatic non-small cell lung cancer (stage IIIb or IV) with stable disease after 4 cycles of standard platinum-based first-line chemotherapy Exclusion Criteria: Not willing or not able to sign written informed consent form
Sex/Gender	Sexes Eligible for Study: All
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	Study Director: Clinical Trials Hoffmann-La Roche
PRS Account	Hoffmann-La Roche
Verification Date	November 2016