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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: February 25, 2016
Last verified: February 2016
  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 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.

Condition Intervention
Nonsquamous Nonsmall Cell Neoplasm of Lung
Drug: Erlotinib

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:
  • 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) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Time to Disease Progression [ Time Frame: Baseline to the end of the study (up to 4 years, 4 months) ] [ Designated as safety issue: No ]
    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.

  • Progression-free Survival [ Time Frame: Baseline to the end of the study (up to 4 years, 4 months) ] [ Designated as safety issue: No ]
    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.

  • Overall Survival [ Time Frame: Baseline to the end of the study (up to 4 years, 4 months) ] [ Designated as safety issue: No ]
    Overall survival was defined as the time from Baseline until or death from any cause

  • 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) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Who Developed Rash [ Time Frame: Baseline to the end of the study (up to 4 years, 4 months) ] [ Designated as safety issue: No ]
    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.


Enrollment: 347
Study Start Date: April 2008
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Drug: Erlotinib
Erlotinib was provided in the retail versions of the product.
Other Name: Tarceva

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Non-small cell lung cancer patients with progressive disease after first-line chemotherapy.
Criteria

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.

  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, 1020
Bruxelles, Belgium, 1050
Bruxelles, Belgium, 1180
Bruxelles, Belgium, 1200
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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01161173     History of Changes
Other Study ID Numbers: ML21474 
Study First Received: July 12, 2010
Results First Received: August 5, 2015
Last Updated: February 25, 2016
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 26, 2016