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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01194050
First received: September 1, 2010
Last updated: September 22, 2014
Last verified: September 2014

September 1, 2010
September 22, 2014
June 2010
July 2013   (final data collection date for primary outcome measure)
Overall survival at 1 year [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01194050 on ClinicalTrials.gov Archive Site
  • Tolerability of Tarceva in daily clinical practice under routine conditions [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Efficacy of Tarceva in daily clinical practice under routine conditions [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Reproducibility of the results of the controlled SATURN study [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
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An Observational Study of Tarceva (Erlotinib) in Routine Practice For First Line Maintenance Therapy in Patients With Non Small Cell Lung Cancer
Erlotinib (Tarceva) in Routine Clinical Practice for First Line Maintenance Therapy (1LM) in Patients With Advanced Non Small Cell Lung Cancer (NSCLC)

This observational study will investigate the tolerability and efficacy of Tarce va (erlotinib) in daily clinical practice under routine conditions in patients w ith locally advanced or metastatic non small cell lung cancer. Data will be coll ected for approximately 12 months.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Probability Sample

Non small cell lung cancer patients

Non-Small Cell Lung Cancer
Not Provided
Cohort
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
289
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01194050
ML22816
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP