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.

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 355

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
  • Barcelona, Spain, 08041
  • Barcelona, Spain, 08916
  • Barcelona, Spain, 08006
  • Caceres, Spain, 10003
  • Girona, Spain, 17007
  • Huesca, Spain, 22004
  • La Coruña, Spain, 15006
  • Leon, Spain, 24071
  • Lugo, Spain, 27003
  • Madrid, Spain, 28040
  • Madrid, Spain, 28046
  • Madrid, Spain, 28905
  • Madrid, Spain, 28007
  • Salamanca, Spain, 37007
  • Teruel, Spain, 44002
  • Toledo, Spain, 45004
  • Valencia, Spain, 46017
  • Valencia, Spain, 46026
  • Valencia, Spain, 41014
  • Valencia, Spain, 46015
  • Valladolid, Spain, 47005
  • Zamora, Spain, 49021
  • Zaragoza, Spain, 50009
  • Alava
    • Vitoria, Alava, Spain, 01009
  • Alicante
    • Elda, Alicante, Spain, 03600
  • Asturias
    • Oviedo, Asturias, Spain, 33011
  • Cantabria
    • Santander, Cantabria, Spain, 39008
  • Guipuzcoa
    • San Sebastian, Guipuzcoa, Spain, 20080
  • Huesca
    • Barbastro, Huesca, Spain, 22300
  • Islas Baleares
    • Mahon, Islas Baleares, Spain, 07703
    • Palma De Mallorca, Islas Baleares, Spain, 07014
  • La Coruña
    • Santiago de Compostela, La Coruña, Spain, 15706
  • La Rioja
    • Logroño, La Rioja, Spain, 26006
  • Las Palmas
    • Las Palmas de Gran Canaria, Las Palmas, Spain, 35020
  • Madrid
    • Alcala de Henares, Madrid, Spain, 28805
  • Malaga
    • Melilla, Malaga, Spain, 52005
  • Tarragona
    • Reus, Tarragona, Spain, 43204
  • Tenerife
    • La Laguna, Tenerife, Spain, 38320
  • Valencia
    • Xativa, Valencia, Spain, 46800
  • Vizcaya
    • Bilbao, Vizcaya, Spain, 48013

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with previously treated advanced NSCLC, with wild-type EGFR gene or squamous cell carcinoma histology

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: December 19, 2011
• First Submitted That Met QC Criteria: January 13, 2012
• First Posted (Estimate): January 19, 2012

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: ML27773