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)

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Prospective, Observational Study to Identify Different Prognostic Factors Related to Survival in Patients With Previously Treated Advanced NSCLC With Wild-type Epidermal Growth Factor Receptor (EGFR) Gene.

Conditions
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Non-Squamous Non-Small Cell Lung Cancer

Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of overall survival with baseline clinical/demographic patient characteristics |  | approximately 2 years | 
| Correlation of overall survival with baseline tumour characteristics |  | approximately 2 years | 
| Correlation of overall survival with previous treatment regimens |  | approximately 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Safety: Incidence of adverse events |  | approximately 2 years |