Prospective, Open-label, Multicenter, National, Non-interventional Phase IV Trial of the Effectiveness, Safety and Tolerability of Tarceva as Second-line Treatment of Patients With Advanced Non-small Cell Lung Cancer (NSCLC), After Failure of First-line Treatment With a Pemetrexed-containing Chemotherapy Regimen
N/A
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Cancer
Both
Non-Small Cell Lung Cancer
Trial Information
Prospective, Open-label, Multicenter, National, Non-interventional Phase IV Trial of the Effectiveness, Safety and Tolerability of Tarceva as Second-line Treatment of Patients With Advanced Non-small Cell Lung Cancer (NSCLC), After Failure of First-line Treatment With a Pemetrexed-containing Chemotherapy Regimen
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Histologically or cytologically documented locally advanced or metastatic non-small
cell lung cancer (inoperable stage III or IV according to 7th TNM classification)
- Experiencing disease progression after pemetrexed-containing first-line chemotherapy
regimen
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Initiated on second-line treatment with Tarceva at the most 4 weeks prior to study
entry at baseline (date of signature of informed consent)
Exclusion Criteria:
- Prior chemotherapy/targeted therapy after disease progression after first-line
treatment in the advanced NSCLC setting
- Contraindication for Tarceva according to the Summary of Product characteristics
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Progression-free survival
Outcome Time Frame:
approximately 3 years
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Belgium: Institutional Review Board
Study ID:
ML25708
NCT ID:
NCT01664533
Start Date:
September 2011
Completion Date:
July 2014
Related Keywords:
- Non-Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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