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)

Non-Squamous Non-Small Cell Lung Cancer Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01512420
• Other study ID #: ML27773
• Status: Completed
• Phase: N/A
• First received: December 19, 2011
• Last updated: November 1, 2016
• Start date: November 2011
• Est. completion date: February 2015

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Espanola de Medicamentos y Productos Sanitarios
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 355
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Squamous Non-Small Cell Lung Cancer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of overall survival with baseline clinical/demographic patient characteristics		approximately 2 years	No
Primary	Correlation of overall survival with baseline tumour characteristics		approximately 2 years	No
Primary	Correlation of overall survival with previous treatment regimens		approximately 2 years	No
Secondary	Objective response rate (ORR), tumour assessments according to RECIST criteria		approximately 2 years	No
Secondary	Disease control rate		approximately 2 years	No
Secondary	Progression-free survival		approximately 2 years	No
Secondary	Safety: Incidence of adverse events		approximately 2 years	No