A 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 4
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Cancer
Both
Non-Small Cell Lung Cancer
Trial Information
A 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 (stage III/IV) non-small cell lung cancer with EGFR
mutations
- Measurable disease according to RECIST criteria
- ECOG performance status 0-2
- Adequate haematological, renal and liver function
Exclusion Criteria:
- Previous chemotherapy or therapy against EGFR for metastatic disease
- History of another malignancy, except for in situ carcinoma of the cervix, adequately
treated basal cell skin carcinoma, or radically treated prostate carcinoma with good
prognosis
- Symptomatic cerebral metastases
- Pre-existing parenchymal lung disease such as pulmonary fibrosis
- 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:
Progression-free survival, tumour assessments according to RECIST criteria
Outcome Time Frame:
36 months
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Finland: Ministry of Health
Study ID:
ML25575
NCT ID:
NCT01287754
Start Date:
October 2011
Completion Date:
September 2015
Related Keywords:
- Non-Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|
