An Observational Study of Tarceva (Erlotinib) in Routine Practice For First Line Maintenance Therapy in Patients With Non Small Cell Lung Cancer

Completed

• Conditions: Non-Squamous Non-Small Cell Lung Cancer

• Registration Number: NCT01194050
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-09-01
• Study First Submitted QC: 2010-09-01
• Study First Posted: 2010-09-02
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 289

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

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Exclusion Criteria

• Not willing or not able to sign written informed consent form

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival at 1 year	12 months

Secondary Outcome Measures

Name	Time	Method
Reproducibility of the results of the controlled SATURN study	12 months
Tolerability of Tarceva in daily clinical practice under routine conditions	12 months
Efficacy of Tarceva in daily clinical practice under routine conditions	12 months