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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

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ClinicalTrials.gov Identifier: NCT01194050
Recruitment Status : Completed
First Posted : September 2, 2010
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease
Non-Squamous Non-Small Cell Lung Cancer

Study Type : Observational
Actual Enrollment : 289 participants
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)
Study Start Date : June 2010
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Group/Cohort
Cohort



Primary Outcome Measures :
  1. Overall survival at 1 year [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Tolerability of Tarceva in daily clinical practice under routine conditions [ Time Frame: 12 months ]
  2. Efficacy of Tarceva in daily clinical practice under routine conditions [ Time Frame: 12 months ]
  3. Reproducibility of the results of the controlled SATURN study [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01194050


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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01194050     History of Changes
Other Study ID Numbers: ML22816
First Posted: September 2, 2010    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action