A Non-interventional Trial of Erlotinib (Tarceva) Metastatic Non-small Cell Lung Cancer

NCT ID: NCT02595450

Last Updated: 2016-01-25

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

299 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Study Completion Date

2014-11-30

Brief Summary

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This is a non-interventional, open label, single arm, multicenter study to assess the safety and efficacy of erlotinib in participants with non-small cell lung cancer.

Detailed Description

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Conditions

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Non-Small Cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Erlotinib

Participants with locally advanced or metastatic non-small cell lung cancer will be treated with erlotinib according to the product label. This non-interventional study will not affect by any means the treatment, medical care or monitoring of the participant, since it reports retrospective data, which already exist in the participants' medical files.

Erlotinib

Intervention Type DRUG

Participants with locally advanced or metastatic non-small cell lung cancer will be treated with erlotinib according to the product label. This non-interventional study will not affect by any means the treatment, medical care or monitoring of the participant, since it reports retrospective data, which already exist in the participants' medical files.

Interventions

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Erlotinib

Participants with locally advanced or metastatic non-small cell lung cancer will be treated with erlotinib according to the product label. This non-interventional study will not affect by any means the treatment, medical care or monitoring of the participant, since it reports retrospective data, which already exist in the participants' medical files.

Intervention Type DRUG

Other Intervention Names

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Tarceva

Eligibility Criteria

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Inclusion Criteria

* It is the physician's decision to prescribe erlotinib in participants and to document their treatment
* Participants must be candidates for receiving erlotinib for locally advanced or metastatic non-small cell lung cancer according to the product label

Exclusion Criteria

* Participants will be excluded if safety concerns occurred
* If the participant was not compliant or if the participant would wish to stop erlotinib therapy
Minimum Eligible Age

35 Years

Maximum Eligible Age

86 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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Bludesch, , Austria

Site Status

Countries

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Austria

Other Identifiers

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ML22190

Identifier Type: -

Identifier Source: org_study_id

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