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:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01161173
First received: July 12, 2010
Last updated: May 7, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This observational study will evaluate the safety and efficacy of Tarceva (erlotinib) in routine clinical practice as second line treatment in patients with recurrent or metastatic Non-Small Cell Lung Cancer (NSCLC). Data will be collected from patients who have received one course of standard systemic chemotherapy, experienced 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: | May 2013 |
| Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Cohort |
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
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: | May 7, 2013 |
| 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 Erlotinib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013