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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01512420
First received: December 19, 2011
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

This prospective observational study will evaluate the efficacy and safety of se cond-line Tarceva (erlotinib) in patients with previously treated advanced non-s mall 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 dem ographic patient characteristics prognostic factors related to overall survival with second-line Tarceva treatment. Data will be collected from eligible patient s for up to 2 years.


Condition
Non-Small Cell Lung Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Correlation of overall survival with baseline clinical/demographic patient characteristics [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Correlation of overall survival with baseline tumour characteristics [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Correlation of overall survival with previous treatment regimens [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rate (ORR), tumour assessments according to RECIST criteria [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Disease control rate [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]

Enrollment: 355
Study Start Date: November 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01512420

Locations
Spain
Vitoria, Alava, Spain, 01009
Elda, Alicante, Spain, 03600
Oviedo, Asturias, Spain, 33006
Santander, Cantabria, Spain, 39008
San Sebastian, Guipuzcoa, Spain, 20080
Barbastro, Huesca, Spain, 22300
Mahon, Islas Baleares, Spain, 07703
Palma De Mallorca, Islas Baleares, Spain, 07014
Santiago de Compostela, La Coruña, Spain, 15706
Logroño, La Rioja, Spain, 26006
Las Palmas de Gran Canaria, Las Palmas, Spain, 35020
Alcala de Henares, Madrid, Spain, 28805
Reus, Tarragona, Spain, 43204
La Laguna, Tenerife, Spain, 38320
Xativa, Valencia, Spain, 46800
Bilbao, Vizcaya, Spain, 48013
Barcelona, Spain, 08916
Barcelona, Spain, 08041
Barcelona, Spain, 08036
Barcelona, Spain, 08006
Caceres, Spain, 10003
Girona, Spain, 17007
Huesca, Spain, 22004
La Coruña, Spain, 15006
Leon, Spain, 24071
Lugo, Spain, 27003
Madrid, Spain, 28007
Madrid, Spain, 28905
Madrid, Spain, 28046
Madrid, Spain, 28040
Melilla, Spain, 52005
Salamanca, Spain, 37007
Teruel, Spain, 44002
Toledo, Spain, 45004
Valencia, Spain, 46015
Valencia, Spain, 46026
Valencia, Spain, 41014
Valencia, Spain, 46017
Valladolid, Spain, 47005
Zamora, Spain, 49021
Zaragoza, Spain, 50009
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01512420     History of Changes
Other Study ID Numbers: ML27773
Study First Received: December 19, 2011
Last Updated: August 26, 2014
Health Authority: Spain: Agencia Espanola de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014