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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

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: November 3, 2014
Last verified: November 2014
  Purpose

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.


Condition
Non-Small Cell Lung Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Erlotinib (Tarceva) in Routine Clinical Practice for First Line Maintenance Therapy (1LM) in Patients With Advanced Non Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Overall survival at 1 year [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 289
Study Start Date: June 2010
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Non small cell lung cancer patients

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01194050

Locations
Germany
Villingen-Schwenningen, Germany, 78052
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01194050     History of Changes
Other Study ID Numbers: ML22816
Study First Received: September 1, 2010
Last Updated: November 3, 2014
Health Authority: Germany: Federal Insititute for Drugs and Medical Devices

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014