An Observational Study of Erlotinib (Tarceva) as Second-line Treatment in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer After Failure of Pemetrexed in First-line Therapy
NCT ID: NCT01664533
Last Updated: 2015-12-28
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
57 participants
OBSERVATIONAL
2011-09-30
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Erlotinib
Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
Erlotinib
Erlotinib was supplied as tablets in the retail product Tarceva.
Interventions
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Erlotinib
Erlotinib was supplied as tablets in the retail product Tarceva.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically documented locally advanced or metastatic non-small cell lung cancer (inoperable Stage III or IV according to the 7th TNM Classification of Malignant Tumors).
* Experiencing disease progression after pemetrexed-containing first-line chemotherapy regimen.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Initiated on second-line treatment with Tarceva at the most 4 weeks prior to study entry at baseline (date of signature of informed consent).
Exclusion Criteria
* Contraindication for Tarceva according to the Summary of Product characteristics.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Aalst, , Belgium
Antwerp, , Belgium
Boussu, , Belgium
Brussels, , Belgium
Charleroi, , Belgium
Dendermonde, , Belgium
Duffel, , Belgium
Edegem, , Belgium
Frameries, , Belgium
Genk, , Belgium
Gilly, , Belgium
Gosselies, , Belgium
Liège, , Belgium
Mons, , Belgium
Montegnée, , Belgium
Namur, , Belgium
Ottignies, , Belgium
Roeselare, , Belgium
Sint-Niklaas, , Belgium
Tournai, , Belgium
Turnhout, , Belgium
Countries
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Other Identifiers
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ML25708
Identifier Type: -
Identifier Source: org_study_id