- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01161173
An Observational Study of Tarceva (Erlotinib) in Routine Daily Clinical Practice as Second Line Treatment in Patients With Non-small Cell Lung Cancer (TEAM)
February 25, 2016 updated by: Hoffmann-La Roche
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
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 dell lung cancer (NSCLC).
Data will be collected from patients who have received 1 course of standard systemic chemotherapy, experienced disease progression, and who are receiveingTarceva in a second-line setting.
Patients will also be followed through third-line treatment if there is disease progression on Tarceva therapy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
347
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Aalst, Belgium, 9300
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Antwerpen, Belgium, 2020
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Arlon, Belgium, 6700
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Bonheiden, Belgium, 2820
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Bouge, Belgium, 5004
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Boussu, Belgium, 7360
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Bruxelles, Belgium, 1020
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Bruxelles, Belgium, 1050
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Bruxelles, Belgium, 1200
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Bruxelles, Belgium, 1180
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Charleroi, Belgium, 6000
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Chimay, Belgium, 6460
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Duffel, Belgium, 2570
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Edegem, Belgium, 2650
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Frameries, Belgium, 7080
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Genk, Belgium, 3600
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Gilly, Belgium, 6060
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Hasselt, Belgium, 3500
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Leuven, Belgium, 3000
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Liege, Belgium, 4000
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Liège, Belgium, 4000
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Marche-En-Famenne, Belgium, 5411
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Mons, Belgium, 7000
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Namur, Belgium, 5000
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Oostende, Belgium, 8400
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Ottignies, Belgium, 1340
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Roeselare, Belgium, 8800
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Seraing, Belgium, 4100
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Sint Niklaas, Belgium, 9100
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Tournai, Belgium, 7500
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Turnhout, Belgium, 2300
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Verviers, Belgium, 4800
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Vilvoorde, Belgium, 1800
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Wilrijk, Belgium, 2610
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Differdange, Luxembourg, 4602
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Esch-alzette, Luxembourg
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Luxembourg, Luxembourg, 1210
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Non-small cell lung cancer patients with progressive disease after first-line chemotherapy.
Description
Inclusion Criteria:
- Adult patients ≥ 18 years of age.
- Written informed consent.
- Recurrent or metastatic, Stage III or IV non-small cell lung cancer (NSCLC).
- Measurable disease (Response Evaluation Criteria In Solid Tumors).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Prior course of standard systemic chemotherapy.
Exclusion Criteria:
- Contra-indications to treatment with Tarceva.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Erlotinib
Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
The recommended daily dose of erlotinib is 150 mg orally once daily.
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Erlotinib was provided in the retail versions of the product.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)
Time Frame: Baseline to the end of the study (up to 4 years, 4 months)
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The best overall response to treatment was determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs.
A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD.
SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started for TLs and the persistence of 1 or more non-TL(s).
PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.
For the best overall responses of CR and PR, a response was "confirmed" if a subsequent RECIST evaluation also showed a CR or PR.
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Baseline to the end of the study (up to 4 years, 4 months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Time to Disease Progression
Time Frame: Baseline to the end of the study (up to 4 years, 4 months)
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The time to disease progression was defined as the time from Baseline until disease progression as determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
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Baseline to the end of the study (up to 4 years, 4 months)
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Progression-free Survival
Time Frame: Baseline to the end of the study (up to 4 years, 4 months)
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Progression-free survival was defined as the time from Baseline until disease progression or death from any cause.
Progressive disease was determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
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Baseline to the end of the study (up to 4 years, 4 months)
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Overall Survival
Time Frame: Baseline to the end of the study (up to 4 years, 4 months)
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Overall survival was defined as the time from Baseline until or death from any cause
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Baseline to the end of the study (up to 4 years, 4 months)
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Change From Baseline in the Lung Cancer Symptom Scale (LCSS) Scores
Time Frame: Baseline to the end of the study (up to 4 years, 4 months)
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Study participants and treating physicians completed the LCSS, a measure of Quality of Life (QoL), at Baseline and throughout the study.
The patient LCSS measures 6 major symptoms, the Symptom Burden Index (SBI), associated with lung malignancies (3 thoracic [cough, dyspnea, haemoptysis] and 3 general symptoms [loss of appetite, fatigue, pain]) and 3 additional scores (overall symptomatic distress, interference with daily activities, global QoL), each on a 100 mm visual analogue scale (0=no impairment, 100=maximum impairment).
The physician LCSS evaluates the 6 lung malignancy associated symptoms, the SBI, on an ordinal scale (100=none, 75=mild, 50=moderate, 25=marked, 0=severe).
The average of the patient and physician SBI scores (6 symptoms) and the average of the patient total score (9 symptoms) ranged from 0 to 100, with a higher patient and a lower physician score indicating more impairment.
A negative patient and a positive physician change score indicates improvement.
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Baseline to the end of the study (up to 4 years, 4 months)
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Percentage of Participants Who Developed Rash
Time Frame: Baseline to the end of the study (up to 4 years, 4 months)
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At each study visit, the presence of skin rash was graded using the Common Toxicity Criteria (CTC), with grade 0 = no rash, grade 1 = mild, grade 2 = moderate, grade 3 = severe, and grade 4 = life threatening or disabling rash.
Reported is the percentage of participants who developed a grade ≥ 1 rash.
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Baseline to the end of the study (up to 4 years, 4 months)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
July 12, 2010
First Submitted That Met QC Criteria
July 12, 2010
First Posted (Estimate)
July 13, 2010
Study Record Updates
Last Update Posted (Estimate)
March 28, 2016
Last Update Submitted That Met QC Criteria
February 25, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ML21474
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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