Phase II, Open-label Study of Erlotinib (Tarceva®) Treatment in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Who Present Activating Mutations in the Tyrosine Kinase Domain of the Epidermal Growth Factor Receptor.
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Cancer
Both
Non-Small Cell Lung Cancer
Trial Information
Phase II, Open-label Study of Erlotinib (Tarceva®) Treatment in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Who Present Activating Mutations in the Tyrosine Kinase Domain of the Epidermal Growth Factor Receptor.
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Locally advanced or metastatic non-small cell lung cancer with EGFR mutations
- Measurable disease according to RECIST criteria
- Adequate haematological, renal and liver function
Exclusion Criteria:
- Previous chemotherapy or therapy against EGFR for metastatic disease
- Symptomatic cerebral metastases
- Pre-existing disease of the lung parenchyma such as lung fibrosis, lymphangitic
carcinomatosis
- History of another malignancy except for carcinoma in-situ of the cervix, adequately
treated basal cell skin carcinoma, or radically treated prostate carcinoma with good
prognosis
- Concomitant use of coumarins
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Response Rate: tumour assessments by computer tomography (CT) or magnetic resonance imaging (MRI) according to RECIST 1.1 criteria
Outcome Time Frame:
approximately 3.5 years
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Portugal: National Pharmacy and Medicines Institute (INFARMED)
Study ID:
ML25434
NCT ID:
NCT01260181
Start Date:
March 2011
Completion Date:
May 2014
Related Keywords:
- Non-Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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