An Observational Study of Tarceva (Erlotinib) in Routine Daily Clinical Practice as Second Line Treatment in Patients With Non-small Cell Lung Cancer

NCT ID: NCT01161173

Last Updated: 2016-03-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

347 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-30

Study Completion Date

2012-08-31

Brief Summary

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This observational study will evaluate the safety and efficacy of Tarceva (erlotinib) in routine clinical practice as second-line treatment in patients with recurrent or metastatic non-small dell lung cancer (NSCLC). Data will be collected from patients who have received 1 course of standard systemic chemotherapy, experienced disease progression, and who are receiveingTarceva in a second-line setting. Patients will also be followed through third-line treatment if there is disease progression on Tarceva therapy.

Detailed Description

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Conditions

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Nonsquamous Nonsmall Cell Neoplasm of Lung

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Erlotinib

Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.

Erlotinib

Intervention Type DRUG

Erlotinib was provided in the retail versions of the product.

Interventions

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Erlotinib

Erlotinib was provided in the retail versions of the product.

Intervention Type DRUG

Other Intervention Names

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Tarceva

Eligibility Criteria

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Inclusion Criteria

* Adult patients ≥ 18 years of age.
* Written informed consent.
* Recurrent or metastatic, Stage III or IV non-small cell lung cancer (NSCLC).
* Measurable disease (Response Evaluation Criteria In Solid Tumors).
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
* Prior course of standard systemic chemotherapy.

Exclusion Criteria

\- Contra-indications to treatment with Tarceva.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Aalst, , Belgium

Site Status

Antwerp, , Belgium

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Arlon, , Belgium

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Bonheiden, , Belgium

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Bouge, , Belgium

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Boussu, , Belgium

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Brussels, , Belgium

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Brussels, , Belgium

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Brussels, , Belgium

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Brussels, , Belgium

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Charleroi, , Belgium

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Chimay, , Belgium

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Duffel, , Belgium

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Edegem, , Belgium

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Frameries, , Belgium

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Genk, , Belgium

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Gilly, , Belgium

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Hasselt, , Belgium

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Leuven, , Belgium

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Liège, , Belgium

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Marche-en-Famenne, , Belgium

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Mons, , Belgium

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Namur, , Belgium

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Ostend, , Belgium

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Ottignies, , Belgium

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Roeselare, , Belgium

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Seraing, , Belgium

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Sint-Niklaas, , Belgium

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Tournai, , Belgium

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Turnhout, , Belgium

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Verviers, , Belgium

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Vilvoorde, , Belgium

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Wilrijk, , Belgium

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Differdange, , Luxembourg

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Esch-alzette, , Luxembourg

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Luxembourg, , Luxembourg

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Countries

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Belgium Luxembourg

Other Identifiers

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ML21474

Identifier Type: -

Identifier Source: org_study_id

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