Clinical trial NCT01512420: 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)
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-01-19
Enrollment: 355
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with previously treated advanced NSCLC, with wild-type EGFR gene or squamous cell carcinoma histology

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.


Eligibility criteria: 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

Primary outcomes:
measure: Correlation of overall survival with baseline clinical/demographic patient characteristics
timeFrame: approximately 2 years
measure: Correlation of overall survival with baseline tumour characteristics
timeFrame: approximately 2 years
measure: Correlation of overall survival with previous treatment regimens
timeFrame: approximately 2 years
Secondary outcomes:
measure: Objective response rate (ORR), tumour assessments according to RECIST criteria
timeFrame: approximately 2 years
measure: Disease control rate
timeFrame: approximately 2 years
measure: Progression-free survival
timeFrame: approximately 2 years
measure: Safety: Incidence of adverse events
timeFrame: approximately 2 years
Other outcomes:
Locations:
city: Vitoria
country: Spain
state: Alava
city: Elda
country: Spain
state: Alicante
city: Oviedo
country: Spain
state: Asturias
city: Santander
country: Spain
state: Cantabria
city: San Sebastian
country: Spain
state: Guipuzcoa
city: Barbastro
country: Spain
state: Huesca
city: Mahon
country: Spain
state: Islas Baleares
city: Palma De Mallorca
country: Spain
state: Islas Baleares
city: Santiago de Compostela
country: Spain
state: La Coruña
city: Logroño
country: Spain
state: La Rioja
city: Las Palmas de Gran Canaria
country: Spain
state: Las Palmas
city: Alcala de Henares
country: Spain
state: Madrid
city: Melilla
country: Spain
state: Malaga
city: Reus
country: Spain
state: Tarragona
city: La Laguna
country: Spain
state: Tenerife
city: Xativa
country: Spain
state: Valencia
city: Bilbao
country: Spain
state: Vizcaya
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Caceres
country: Spain
city: Girona
country: Spain
city: Huesca
country: Spain
city: La Coruña
country: Spain
city: Leon
country: Spain
city: Lugo
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Salamanca
country: Spain
city: Teruel
country: Spain
city: Toledo
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Valladolid
country: Spain
city: Zamora
country: Spain
city: Zaragoza
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: