An Observational Study of Tarceva (Erlotinib) in Routine Daily Clinical Practice as Second Line Treatment in Patients With Non-Small Cell Lung Cancer (TEAM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01161173
First received: July 12, 2010
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This observational study will evaluate the safety and efficacy of Tarceva (erlot inib) in routine clinical practice as second line treatment in patients with rec urrent or metastatic Non-Small Cell Lung Cancer (NSCLC). Data will be collected from patients who have received one course of standard systemic chemotherapy, ex perienced disease progression, and who receive Tarceva treatment in second-line setting. Patients will be followed also through third line treatment if there is disease progression on Tarceva therapy.


Condition
Non-Small Cell Lung Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Non-interventional Study to Follow and Evaluate Patients With Advanced NSCLC Who Are Treated in Second Line Setting With Tarceva (Erlotinib) in a "Real Life" Clinical Setting

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Efficacy in routine daily oncology practice: tumor assessments, European Cooperative Oncology Group (ECOG) performance status, quality of life (Lung Cancer Symptom Scale), as available [ Time Frame: 44 months ] [ Designated as safety issue: No ]
  • Safety: Adverse events [ Time Frame: 44 months ] [ Designated as safety issue: No ]

Enrollment: 350
Study Start Date: April 2008
Study Completion Date: August 2012
Primary Completion Date: August 2012 (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

NSCLC patients with PD after 1st line chemotherapy

Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Recurrent or metastatic, Stage III or IV Non-Small Cell Lung Cancer (NSCLC)
  • Measurable disease (RECIST criteria)
  • ECOG performance status 0-2
  • Prior course of standard systemic chemotherapy

Exclusion Criteria:

  • Contra-indications to treatment with Tarceva
  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: NCT01161173

Locations
Belgium
Aalst, Belgium, 9300
Antwerpen, Belgium, 2020
Arlon, Belgium, 6700
Bonheiden, Belgium, 2820
Bouge, Belgium, 5004
Boussu, Belgium, 7360
Bruxelles, Belgium, 1180
Bruxelles, Belgium, 1200
Bruxelles, Belgium, 1050
Bruxelles, Belgium, 1020
Charleroi, Belgium, 6000
Chimay, Belgium, 6460
Duffel, Belgium, 2570
Edegem, Belgium, 2650
Frameries, Belgium, 7080
Genk, Belgium, 3600
Gilly, Belgium, 6060
Hasselt, Belgium, 3500
Leuven, Belgium, 3000
Liege, Belgium, 4000
Liège, Belgium, 4000
Marche-En-Famenne, Belgium, 5411
Mons, Belgium, 7000
Namur, Belgium, 5000
Oostende, Belgium, 8400
Ottignies, Belgium, 1340
Roeselare, Belgium, 8800
Seraing, Belgium, 4100
Sint Niklaas, Belgium, 9100
Tournai, Belgium, 7500
Turnhout, Belgium, 2300
Verviers, Belgium, 4800
Vilvoorde, Belgium, 1800
Wilrijk, Belgium, 2610
Luxembourg
Differdange, Luxembourg, 4602
Esch-alzette, Luxembourg
Luxembourg, Luxembourg, 1210
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: NCT01161173     History of Changes
Other Study ID Numbers: ML21474
Study First Received: July 12, 2010
Last Updated: August 4, 2014
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 22, 2014