An Observational Study of Tarceva (Erlotinib) in Patients With Non-Small Cell Lung Cancer

Completed

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

• Registration Number: NCT01488331
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This prospective, multi-center, observational study will assess the progression-free survival and safety of patients with locally advanced or metastatic non-small cell lung cancer treated with Tarceva (erlotinib) and not disease progressing after at least 9 months. Data will be collected for 24 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2011-12-06
• Study First Submitted QC: 2011-12-07
• Study First Posted: 2011-12-08
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 217

Inclusion Criteria

• Adult patients, >/=18 years of age
• Diagnosis of locally advanced or metastatic non-small cell lung cancer (NSCLC, stage III/IV)
• Treatment with Tarceva monotherapy and not progressing after at least 9 months at the date of study start

Exclusion Criteria

• Not agreeing to be followed-up (for a maximum of 24 months)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival	24 months

Secondary Outcome Measures

Name	Time	Method
Overall survival	24 months
Treatment compliance of patient	24 months
Best treatment response	24 months
Safety (incidence of adverse events)	24 months
Type of treatment response	24 months