An Observational Study of Tarceva (Erlotinib) in Previously Treated Patients With Advanced Non-Small Cell Lung Cancer With Wild-Type Epidermal Growth Factor Receptor (EGFR) Gene (WILT)

Completed

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

• Registration Number: NCT01512420
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This prospective observational study will evaluate the efficacy and safety of second-line Tarceva (erlotinib) in patients with previously treated advanced non-small cell lung cancer with confirmed wild-type epidermal growth factor receptor (EGFR) gene. The aim of the study is to identify from baseline clinical and demographic patient characteristics prognostic factors related to overall survival with second-line Tarceva treatment. Data will be collected from eligible patients for up to 2 years.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-12-19
• Study First Submitted QC: 2012-01-13
• Study First Posted: 2012-01-19
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 355

Inclusion Criteria

• Adult patients, >/= 18 years of age
• Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC)
• Patients with known wild-type EGFR gene; patients with unknown EGFR mutation status are allowed if they fulfil the following criteria:
• squamous cell carcinoma lung cancer histology, and
• current smoker, or former smoker who has stopped smoking less than 10 years ago and has had a total of >15 pack-years of smoking
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
• Patients having failed one prior chemotherapy regimen and eligible for a second-line treatment with Tarceva

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Exclusion Criteria

• Current treatment with an investigational drug or participation in another investigational study
• Severe or uncontrolled systemic disease, active infection, concomitant malignancy or a second primary malignancy except for in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin
• Clinically active interstitial lung disease
• Recent myocardial infarction or unstable angina
• Progressive or uncontrolled brain metastases

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation of overall survival with previous treatment regimens	approximately 2 years
Correlation of overall survival with baseline clinical/demographic patient characteristics	approximately 2 years
Correlation of overall survival with baseline tumour characteristics	approximately 2 years

Secondary Outcome Measures

Name	Time	Method
Safety: Incidence of adverse events	approximately 2 years
Objective response rate (ORR), tumour assessments according to RECIST criteria	approximately 2 years
Disease control rate	approximately 2 years
Progression-free survival	approximately 2 years