Phase IIIb, 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 (ESSENCE)
Phase 3
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 IIIb, 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 (ESSENCE)
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Diagnosis of locally advanced or metastatic non-small cell lung cancer with
activating mutations in the tyrosine kinase domain of the epidermal growth factor
receptor (EGFR)
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Life expectancy >/=12 weeks
- Adequate hematological, liver and renal function
Exclusion Criteria:
- Previous chemotherapy or treatment against EGFR for metastatic disease
- Treatment with an investigational agent less than 3 weeks before enrolment
- History of neoplasm other than non-small cell lung cancer (except carcinoma in situ
of the uterine cervix, basal cell skin carcinoma, or prostate carcinoma)
- Patients with symptomatic cerebral metastases
- Any significant ophthalmologic abnormality
- Unstable systemic disease
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
Outcome Time Frame:
Approximately 2 years
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Serbia: Agency for Medicines and Medical Devices
Study ID:
ML27860
NCT ID:
NCT01667562
Start Date:
January 2012
Completion Date:
December 2014
Related Keywords:
- Non-Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|
