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 (EGFR) - (TRIGGER)
Inclusion Criteria:
- Adult patients, >/=18 years of age
- Locally advanced or metastatic non-small cell lung cancer
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Life expectancy over >/=12 weeks
- Adequate hematological, liver, or kidney function
Exclusion Criteria:
- Previous therapy against epidermal growth factor receptor for metastatic disease
- Treatment with investigational drug during the 3 weeks before enrollment
- History of neoplasm
- Patients with symptomatic cerebral metastases
- 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:
12 months
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Italy: Ministry of Health
Study ID:
ML25514
NCT ID:
NCT01378962
Start Date:
March 2011
Completion Date:
June 2013
Related Keywords:
- Non-Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms