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)

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01512420

Enrollment

355

Registered

2012-01-19

Start date

2011-11-30

Completion date

2015-02-28

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Squamous Non-Small Cell Lung Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	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

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

Countries

Spain

Outcome results